TY - JOUR
AU1 - Hilliard, Marisa, E
AU2 - Eshtehardi, Sahar, S
AU3 - Minard, Charles, G
AU4 - Wheat,, Suzanne
AU5 - Gunn,, Sheila
AU6 - Sanders,, Cynthia
AU7 - Klenk,, Robyn
AU8 - Anderson, Barbara, J
AB - Abstract Objective Given persistent challenges achieving optimal diabetes outcomes in adolescence, new interventions to support disease self-management and emotional well-being are needed. Approaches that emphasize adolescents’ positive behaviors and attitudes (“strengths”) are designed to incorporate positive provider communications into clinical encounters to encourage youths’ engagement in adherence behaviors and enhance well-being. Methods This pilot study tested the feasibility, acceptability, and preliminary outcomes of a brief, strengths-based behavioral intervention for adolescents with type 1 diabetes. Adolescents (age 12–17 years) and parents were recruited, consented, and completed baseline and postintervention questionnaires. There was no randomization to a control group, and all participants received the pilot intervention. At the start of two clinic visits, diabetes care providers followed a semi-structured script to reinforce adolescents’ diabetes-related strengths and adherence behaviors. Results Of 116 eligible families, 84 consented and 64 completed baseline (M age = 15.0 ± 1.8 years, 56% female, 69% White, M HbA1c = 8.6 ± 1.6%). Providers reported the intervention usually (95%) took <10 min to deliver. Participants and providers enjoyed the intervention and would like to see it as part of routine clinical care. Pre–post data indicated significant improvements in youth-rated diabetes strengths, adherence, burden, and relationship with provider, parent-reported diabetes burden, and provider-rated relationship with family (p < .05). Objectively measured adherence and glycemic control did not change. Conclusions This brief strengths-based, clinic-integrated intervention was feasible to conduct and stakeholders were satisfied. This intervention holds promise to have a positive impact on adolescents’ diabetes adherence, well-being, and provider relationships. Lessons were learned to improve implementation and participant experience for a larger study. adherence, behavioral intervention, strengths, type 1 diabetes Type 1 diabetes (T1D) is the most common chronic condition of childhood (Mayer-Davis et al., 2017) and has complex daily self-management demands. Deteriorations in adherence and glycemic control are common during adolescence (Helgeson et al., 2017; King, Berg, Butner, Butler, & Wiebe, 2014). Risk factors for poor outcomes include emotional distress, diabetes burden, and family conflict (Hilliard, Wu, Rausch, Dolan, & Hood, 2013), and protective factors include an optimistic outlook, adaptive coping strategies, and supportive parental involvement (Yi-Frazier, Hilliard, Cochrane, & Hood, 2012). The Diabetes Resilience Model aims to identify and enhance positive individual, family, and systems-level processes (“strengths”) that help youth with T1D achieve good adherence, quality of life, and glycemic control (“resilient outcomes”) despite the challenges of T1D (Hilliard, Harris, & Weissberg-Benchell, 2012). Empirically supported behavioral interventions designed to reduce risk factors can help to reduce or prevent worsening outcomes in adolescence by teaching new skills to address diabetes-related problems (Hood, Rohan Peterson, & Drotar, 2010). Fewer behavioral interventions target resilient outcomes by identifying, reinforcing, and building on youths’ and families’ diabetes strengths (Fogel & Weissberg-Benchell, 2010). Strengths-based interventions delivered in classrooms have been successful in improving children’s academic and psychological outcomes (Shankland & Rossett, 2017; Taylor, Oberle, Durlak, & Weissberg, 2017), and similar approaches have begun to be used with pediatric populations. Pilot studies using positive psychology approaches with adolescents with T1D have also shown promise. For example, Promoting Resilience in Stress Management taught stress management skills and reported high participant satisfaction (Rosenberg et al., 2015), and Check It! used a combination of positive psychology exercises, token rewards, and parental affirmations, and showed that participants with greater positive affect had more improvements in adherence (Jaser, Patel, Rothman, Choi, & Whittemore, 2014). To reduce logistical and financial barriers to delivering behavioral interventions, there have also been efforts to integrate brief behavioral support into routine diabetes care (Datye, Moore, Russell, & Jaser, 2015). Intervention strategies delivered by diabetes providers during clinic appointments (e.g., discussions about quality of life or strategies for family involvement in T1D management) have had positive results and hold promise for implementation in routine care (De Wit et al., 2008; Monaghan et al., 2015). The purpose of the Diabetes Strengths Study was to pilot test a brief, strengths-based, clinic-integrated behavioral intervention delivered by medical providers in the context of routine ambulatory diabetes care, designed to support diabetes management and well-being among adolescents with T1D and their families. The emphasis of the intervention was to help providers highlight and reinforce youths’ and families’ current strengths and positive diabetes management behaviors (i.e., adherence) during clinical encounters. Youth with T1D attend diabetes clinic approximately quarterly, and this intervention was designed to take place at two consecutive routine appointments. The intervention consisted of assessing youth and family diabetes strengths and adherence before each visit, and training providers to start the clinical encounters with a semi-structured script that reinforced each patient and family’s unique “Diabetes Strengths Profile” generated from the strengths and adherence assessments. With its foundation in the Diabetes Resilience Model (Hilliard et al., 2012), this intervention aimed to promote resilient outcomes by strengthening existing protective behaviors and establishing supportive, patient-centered processes within the health-care system. The aims of the pilot Diabetes Strengths Study were to assess the feasibility and acceptability of the intervention and evaluate preliminary impact on clinical diabetes and emotional outcomes, and on patient/family–provider relationships. The intervention was hypothesized to be feasible to deliver and acceptable to participants and providers. Preliminary data were hypothesized to suggest improvements in adherence, glycemic control (i.e., HbA1c would decrease), diabetes strengths, family conflict, diabetes burden, and satisfaction with patient–provider relationships from preintervention to postintervention (approximately 4-month intervention period). Methods Intervention The intervention was delivered during two consecutive diabetes clinic appointments (typically scheduled 3–4 months apart). The dose of two sessions was selected based on success and feasibility reported by other brief clinician-delivered interventions with one to three sessions (De Wit et al., 2008; Monaghan et al., 2015). Before each appointment, adolescents and parents separately completed one assessment measure online to guide the intervention content: adolescents rated specific diabetes strengths and parents rated adolescents’ behavioral adherence to diabetes management tasks (described below). The first session’s assessment measure was included in the baseline assessment battery; for the second session, the assessment measure was administered alone (the full battery was not administered before the second session). Using the responses, a report (“Diabetes Strengths Profile,” Figure 1) was automatically generated, which study staff printed and distributed to the provider, adolescent, and parent. The Diabetes Strengths Profile highlighted the highest-rated positive behaviors from the assessment measures, following an algorithm that ensured that all profiles had at least three adolescent-reported diabetes strengths and three parent-reported adherence behaviors (described below). Figure 1. View largeDownload slide Example Diabetes Strengths Profile reviewed during intervention sessions by diabetes care provider at start of clinic visit. Figure 1. View largeDownload slide Example Diabetes Strengths Profile reviewed during intervention sessions by diabetes care provider at start of clinic visit. Providers were trained to review the Diabetes Strengths Profile with the adolescent and family at the start of their clinical encounters and to provide supportive feedback using the following structure: (1) review the Diabetes Strengths Profile items, (2) make positive, reinforcing statements, (3) elicit discussion about the strength and adherence behaviors, focusing on what the adolescent is doing well, and (4) encourage the adolescent to identify ways to continue to build on the strengths and/or engage in the adherence behaviors. Providers focused the conversation on the adolescent and engaged the parent after the adolescent had a chance to comment. The conversation was intended to last 5–10 min to minimize interference with clinic flow. Provider training consisted of a 2-hr session with the principal investigator (PI) and study staff before participant enrollment, including instruction in how to provide positive feedback based on the adolescent’s unique set of diabetes strengths per the study protocol, demonstration, and role-play. Approximately 6 months after the initial training, there was a 1-hr booster session including protocol review and role-play. The PI and study staff were also available as needed to answer questions. This pilot study used a single-arm design without a control group. All adolescent–parent dyads received the intervention at two consecutive diabetes clinic appointments and were therefore not blinded to study condition. For the purpose of assessing feasibility and acceptability, this design permitted more participants to be exposed to the intervention in less time than alternative designs with a control group. This increased the ability to assess participant and provider perceptions about the intervention, obtain feedback to refine the intervention, and detect pre–post changes in study outcomes (Phase IIa; Czajkowski et al., 2015). Procedure This study was approved by the local institutional review board. Potentially eligible participants were identified by reviewing upcoming diabetes clinic schedules at two community-based clinic locations of a large, tertiary children’s hospital system in the Southern United States. Study staff conducted eligibility screenings via the electronic medical record for all patients scheduled for upcoming appointments with the providers trained to deliver the intervention, and mailed an informational letter about the study to potentially eligible families. Staff called each family to confirm eligibility, describe the study, answer questions, and obtain verbal informed consent from a parent/legal guardian and adolescent assent. Signed consent/assent forms were mailed back to the study team. Participants (parents and adolescents) were then e-mailed a link to complete the baseline assessment battery at home via password-protected, HIPAA-compliant web survey before their next clinic appointment. Preintervention e-mails were typically sent 4 weeks before the scheduled clinic visit at which the first intervention session would take place. For anyone unable to complete the assessment battery before the visit, a tablet computer was available in the waiting room. Four weeks before the second clinic visit, participants were e-mailed a link to complete a single assessment measure that would be used to guide the content of the second intervention session as described above. Immediately following the second intervention session, participants completed a postintervention assessment battery and a qualitative interview about their experience to provide feedback. To encourage complete data collection, participants received: $10/person/visit for baseline and postintervention assessment batteries, $5/visit for bringing blood glucose meter(s) for download, and $12/visit for parking/transportation expenses. Because completing the assessment measure online before the second session was part of the intervention, no incentive was offered so as not to coerce participant engagement in the intervention. To recruit diabetes care providers to deliver the intervention, the PI made a research presentation to the diabetes service faculty to inform them about the study, and then invited four providers who expressed interest in behavioral research to participate, described the study and their roles, and obtained written informed consent. The providers then attended a training session and delivered the intervention at the start of each clinic appointment with patients who were participating in the study (described above). Following each visit with a participant, providers completed a brief questionnaire about the session (described below). At the end of the study period, each provider completed a qualitative interview to comment on their experience and provide feedback. Providers did not receive financial incentives but were given a personalized pediatric stethoscope decorated with the study logo in appreciation of their contributions. Participants Eligibility criteria included age 12–17 years, T1D diagnosis for ≥12 months, and English fluency (validated assessment measures were not available in other languages). Adolescents or parents with serious mental illness or developmental disability that would impede participation were excluded. Providers with a caseload ≥20 adolescents with T1D were eligible. Measures All assessment measures were collected as part of the baseline (preintervention) and postintervention assessment batteries. Intervention Assessment Measures Two assessment measures were completed three times: before each intervention session (first, as part of the baseline assessment battery, and second, as a single measure before the second session) and in the postintervention assessment battery (completed immediately following the second study visit). Responses on these two assessment measures were used to populate the Diabetes Strengths Profile for each intervention session using the algorithms described below. Adolescents self-reported on the frequency with which they engaged in 12 diabetes-related strengths (i.e., positive attitudes and behaviors related to living with and managing T1D) via the Diabetes Strengths and Resilience measure for Adolescents (DSTAR-A) (Hilliard, Iturralde, Weissberg-Benchell, & Hood, 2017). See example items in Figure 1. The items ask about each item in general, without a specified recall period. Adolescents rated each item on a five-point scale from Never to Almost Always, and higher scores indicated more strengths. Internal reliability was good: α = 0.82. For the Diabetes Strengths Profile, all items with a rating of Almost Always were included as the adolescent’s top strengths; if fewer than three items received that response, all items with a rating of Often were also included, and so on until the profile had three or more items. Parents rated adolescents’ adherence to the diabetes regimen using the parent-report form of the 24-item Diabetes Self-Management Profile Self-Report (DSMP-SR) (Wysocki, Buckloh, Antal, Lochrie, & Taylor, 2012). Respondents were administered one of two versions of the DSMP-SR, based on the adolescents’ current insulin regimen (conventional or intensive). Each item described a diabetes management task (see example items in Figure 1) and respondents selected the response option that best represented their adolescent’s behavior over the past 3 months. Higher scores indicated greater adherence. Internal reliability was acceptable: α = 0.69. An algorithm was created based on feedback from diabetes care providers who ranked the clinical importance of each item. Examples of the items ranked most important included responding yes to “keep something handy in case of an insulin reaction or blood sugar low,” checking blood sugar four or more times per day, and doing ketone tests when sick usually once per day or more frequently. All items ranked as most important and that the parent endorsed were included on the Diabetes Strengths Profile; if fewer than three top-ranked items were endorsed, all items ranked as second most important and endorsed by the parent were also included, and so on until the profile had three or more items. Outcomes The following assessment measures were collected in the baseline and postintervention assessment batteries. Clinical diabetes outcomes including glycemic control (glycosylated hemoglobin A1c, HbA1c) and blood glucose monitoring adherence were collected as part of routine care at each appointment. HbA1c was assessed via fingerstick capillary blood assay, analyzed using a DCA 2000+ HbA1c Analyzer (Siemens-Bayer, Inc.) point of care machine, and values were extracted from the electronic medical record. Adherence was assessed objectively via mean daily blood glucose monitoring frequency over the previous 2 weeks, calculated from timestamped blood glucose monitoring events downloaded from the participant’s blood glucose meter(s). Adverse events including emergency department visits and hospital admissions were monitored through the electronic health record. Adolescents completed the self-report form of the DSMP-SR (described above, youth-report not used for Diabetes Strengths Profiles). Internal reliability was acceptable: α = 0.73. Diabetes burden was assessed via the Problem Areas in Diabetes measures for adolescents (PAID-T, 26 items) (Weissberg-Benchell & Antisdel-Lomaglio, 2011) and parents (PAID-PR, 18 items) (Markowitz et al., 2012). Participants rated the degree to which each item bothered them over the past month on a six-point scale from Not a Problem to Serious Problem. Higher scores indicated more diabetes burden. Internal reliability was excellent: α = 0.95 for both raters. Parents and adolescents also completed the Diabetes Family Conflict Scale Revised (DFCS-R) (Hood et al., 2007), on which they rated the frequency with which their family recently (no specific recall period) argued about 19 diabetes-related topics on a three-point scale from Almost Never to Almost Always. Higher scores indicated more diabetes-related family conflict. Internal reliability was good: α = 0.87 (adolescent), 0.83 (parent). To assess the family–provider relationship, parents completed three subscales of the Pediatric Quality of Life Inventory Healthcare Satisfaction Generic Module (PedsQL-HS) (Varni et al., 2004), assessing satisfaction with communication, inclusion of family, and how well the patient’s emotional needs are addressed during clinical encounters (13 items). No specific recall period is specified. Internal reliability was good: α = 0.86. Adolescents rated their overall (no specific recall period) satisfaction with the patient–provider relationship on a 1–10 scale single item, as there is no validated youth-report measure of satisfaction with care. Higher scores indicated better relationships on both measures. Provider assessment measures Immediately following each clinical encounter with a participating family, providers rated their overall (no specific recall period) satisfaction with the patient–provider relationship on a 1–10 scale single item and documented whether they delivered the intervention, how long it took, how involved the family was, and their comfort delivering the intervention. If they did not deliver the intervention during the appointment, they selected the reason why from a list. Fidelity and Process Assessments The PI or study staff observed —one to two of each provider’s intervention sessions (n = 6 observations total) and completed a nine-item intervention checklist rating the degree to which intervention components (e.g., when during the encounter strengths were reviewed, how many strengths were reviewed) were delivered and process observations (e.g., length of time spent delivering intervention, engagement level of adolescent and parent). Intervention Feedback After the second intervention session, all participants completed a qualitative interview with a research coordinator trained in conducting semi-structured, open-ended interviews about their experiences in the study to provide feedback and recommendations to improve intervention delivery or content. Providers were asked about their experiences integrating the intervention into routine care, perceptions of intervention feasibility, and impact on clinic flow. Statistical Analysis Plan Before analysis, the data were cleaned and examined for missingness, outliers, skewness, and kurtosis. To assess feasibility, participation proportions in each phase of the study (i.e., consent, baseline questionnaires, intervention receipt, and postintervention questionnaires) were calculated. Provider-reported data on the proportion of appointments in which the intervention was delivered and the time it took were also compiled. To assess acceptability, the interviewer made field notes about participant and provider qualitative feedback after each postintervention interview, which were reviewed by the study team. The sample size was selected to gather maximum data on feasibility, acceptability, and feedback to refine the intervention. Preliminary data on change in outcomes were the secondary aim of this pilot study, and the sample was not powered to detect changes in outcome measures. To explore individual change preintervention to postintervention, general linear mixed models were used to test the null hypothesis that there was no change in each outcome. Regression models included fixed effects for time (discrete), and the matrix correlated error terms assumed an unstructured format. This method used all available data, and the models were also adjusted for diabetes duration. Distributional and residual analyses for PedsQL-HS total score indicated that general mixed model assumptions were invalid; instead, the difference in total scores (postintervention minus baseline) was computed and the Wilcoxon signed rank test was used. Baseline data were included for all participants even if postintervention data were missing, and analyses of the DSTAR-A and DSMP-SR also included data from the second intervention session assessment measure. Total scores for all questionnaires, including any with missing items, were calculated following the published scoring instructions. Tukey’s method was used to adjust p-values for multiple comparisons for measures observed at three time points. All analyses were conducted using SAS version 9.4 (Cary, NC). Results Feasibility Figure 2 summarizes participant recruitment and engagement in each step of the study. Over the course of 12 months (October 2014–September 2015), study staff screened 212 adolescents for eligibility via the electronic medical record, of whom 8 could not be contacted, 11 opted out of learning about research before the study could be introduced, and 88 were ineligible. Of the remaining 105 adolescents, 21 declined to participate, resulting in a consent rate of 80% (n = 84). Of those, 64 (76% of consented participants, 61% of all eligible invited to participate) completed baseline questionnaires and 63 (75% of consented, 60% of eligible) received at least one intervention session. The remainder were unable to continue participation because they began receiving diabetes care from a provider not trained in the intervention (n = 9), their provider retired and they were not rescheduled with another trained provider within the study period (n = 10), or they had personal time constraints (n = 1). The second intervention session and postintervention questionnaires were completed by 53 families. Ten did not complete the second intervention session because their provider retired and they were not rescheduled with another participating provider within the study period (n = 2), no subsequent clinic appointment was scheduled within the study period (n = 6), or they transferred to adult care (n = 2). Participants who did not complete a second intervention session for any reason were invited by telephone or e-mail to complete the postintervention data approximately 3–4 months after their first session, around the time that the second intervention session would have taken place. Seven participants who received only one intervention session completed postintervention questionnaires, resulting in a total of n = 60 (71%) with baseline and postintervention data. Data collection took place between December 2014 and August 2016. Figure 2. View largeDownload slide Participant flow diagram. Figure 2. View largeDownload slide Participant flow diagram. Participating adolescents with baseline data (n = 64) were 56% female, mean age at consent was 15.0 years (SD = 1.8), and mean HbA1c was 8.6% (SD = 1.6). The majority (94%) used an intensive insulin regimen via basal/bolus injections or insulin pump. Participants had private insurance (80%), public insurance (16%), or both (4%). Adolescent race was 69% White, 13% Black/African-American, 6% Asian, and 13% other/more than one, and 23% reported Hispanic/Latino ethnicity. Participating parents were 81% mothers. The majority (77%) of homes had two or more caregivers, and 58% had at least one parent with a 4-year college degree or higher. Four diabetes care providers were invited to participate in the role of delivering the intervention. All four (100%) consented and all were trained. Participating providers were 100% female and included one physician and three nurse practitioners. They reported delivering the intervention in all but one instance in which a medical emergency took priority (95%) and that the intervention session lasted <5 min 24% of the time, 5–10 min 72% of the time, and >10 min 4% of the time. They rated the adolescents and parents, respectively, as Somewhat (36%, 23%) or Very Involved (66%, 69%) in the strengths conversations. Providers also rated themselves as Somewhat (7%) or Very Much (93%) comfortable delivering the strengths-based intervention. Six feasibility observations showed that providers consistently addressed two or more youth-reported strengths and two or more parent-reported adherence behaviors on the Diabetes Strengths Profile (100%), made statements to reinforce the behaviors (100%), successfully elicited discussion with adolescents about their strengths (67%), and either somewhat or very much initiated discussion about how to continue to build strengths (67%, 23%). In the observed sessions, 50% of conversations were directed to adolescents only and 50% were directed to both adolescents and parents, and the interventions usually lasted 5–10 min (83%). Acceptability Postintervention feedback from adolescents, parents, and providers was largely positive. Most parents and adolescents described the strengths conversations as comfortable and would like this to be integrated into one to two clinic appointments per year. Several described appreciating a shift in their provider’s communication style, from discussing problems to discussing what is going right in diabetes management. An adolescent said she was glad her provider focused on topics other than HbA1c. A parent described being more aware that their provider cared about emotional well-being in addition to physical health and that her adolescent maintained a more positive attitude during the visit. Several commented on feeling more motivated to come to clinic, less worried about problems that might be brought up, and enjoying starting the appointment on a positive note. Parents and adolescents identified positive experiences after receiving the intervention including increased awareness of what the adolescent was doing well for their diabetes self-management, greater adolescent openness to talking about diabetes, and increased adolescent attentiveness to diabetes management tasks. One adolescent said discussing her strengths with her provider helped her keep a positive attitude even when her HbA1c was not “perfect.” Several adolescents talked about setting self-management goals after the intervention visits; some said it made them want to work on diabetes tasks they were not doing as well, and others described feeling motivated to continue working on behaviors they had already had success with. For example, one adolescent downloaded a fitness app to increase her physical activity, and another planned to tell her friends more about diabetes to get their support. Many parents described feeling reassured about their adolescent’s diabetes management and more at ease with their adolescent taking on greater independence, especially those who would be leaving for college soon. Most participants had no suggestions to change the intervention, but two families thought it would be helpful to add a discussion of areas to improve in addition to strengths. A few families were neutral about the intervention and one thought it was not useful because their adolescent’s HbA1c did not decrease. Some participants described benefits of completing the assessment measures, including renewed awareness of the everyday self-management tasks they do and putting their experiences into perspective (e.g., realizing they do not argue about diabetes as much as they thought, feeling validated that others must face similar challenges). Most said the measures were not too time-consuming or difficult and appreciated the online format. Suggestions from others included having fewer or shorter measures, changing questions that were confusing or not relevant to their care (e.g., about meal plans), and wanting to add comments about the responses they selected. Providers said the training and structured format for the strengths conversations prompted a shift in their approach: reminding them to ask questions they did not typically ask and to start each clinical encounter with a positive perspective. Having the assessment measure responses listed on Diabetes Strengths Profile made it easier for them to discuss the strengths most relevant to the family without having to decide what positive topics or adherence behaviors to discuss. They sometimes found it difficult to not drift toward discussing problems but returned to their patients’ strengths later and ended the appointments by discussing a positive topic, despite these not being part of the training or intervention script. Providers all said they felt comfortable delivering the intervention, and they thought it helped parents and adolescents engage in positive conversation during the appointment. Despite the time spent delivering the intervention during the clinic appointment, the providers felt this approach was valuable, and they would like to see the Diabetes Strengths Profile and strengths conversation integrated into routine care processes at two to four visits per year. No providers raised concerns about having difficulty obtaining or interpreting the Profiles or about the intervention having a negative impact on clinic flow. Preliminary Outcomes Mean scores from the 64 families who consented and completed baseline data are summarized in Table I. All regression models analyzing change in scores were adjusted for diabetes duration. On average, DSTAR-A scores increased from baseline to postintervention by 2.6 points (95% confidence interval [CI] = 1.1, 4.1; p < .001). Scores also increased from the second time point (before the second intervention session) to postintervention by 1.5 points (95% CI = 0.6, 2.4; p < .001), but there was no significant change between baseline and the second time point (p = .15). Adolescent-reported DSMP-SR scores increased from baseline to postintervention by 4.4 points (95% CI = 1.8, 6.9; p = .001), but parent-reported DSMP-SR scores did not significantly increase from baseline to the second time point (p = .98) or postintervention (p = .21). However, the change of 1.7 points from the second time point to postintervention was significant (95% CI = 0.02, 3.4; p < .05). There was no significant change from baseline to postintervention in objectively assessed adherence to blood glucose monitoring (p = .73) or HbA1c (p = .51). Table I. Participant Scores at Baseline, Before the Second Intervention Session, and Postintervention Measure Baseline Before second session Postintervention Mean changea (95% CI) pb N M ± SD N M ± SD N M ± SD DSTAR-A (Diabetes Strengths) 64 37.0 ± 6.6 53 38.1 ± 5.6 61 39.7 ± 5.8 2.6 (1.1, 4.1) .0003 DSMP-SR (Adherence), Adolescent-report 62 52.5 ± 10.3 59 56.9 ± 10.1 4.4 (1.8, 6.9) .0012 DSMP-SR (Adherence), Parent-report 63 54.4 ± 9.2 53 55.2 ± 9.5 59 56.9 ± 10.0 1.9 (−0.7, 4.5) .2051 Blood glucose monitoring adherence 58 3.6 ± 1.4 53 3.7 ± 1.8 0.07 (−0.3, 0.5) .7260 Glycemic control (HbA1c) 62 8.6 ± 1.6 59 8.5 ± 1.6 0.11 (−0.1, 0.4) .3682 PAID-T (diabetes burden), Adolescent-report 64 68.6 ± 28.0 61 61.6 ± 23.6 −5.5 (−10.1, −.0.8) .0231 PAID-PR (diabetes burden), Parent-report 64 71.3 ± 25.2 59 64.6 ± 20.3 −6.5 (−10.9, −2.0) .0050 DFCS-R (diabetes family conflict), Adolescent-report 62 25.5 ± 5.7 60 24.3 ± 4.8 −1.3 (−2.3, −0.4) .0058 DFCS-R (diabetes family conflict), Parent-report 64 24.7 ± 4.8 58 24.9 ± 4.6 −0.1 (−0.9, 0.7) .8429 Adolescent–provider relationship, Adolescent-report 62 7.9 ± 1.6 56 8.5 ± 1.8 0.6 (0.1, 1.1) .0185 Provider–family relationship, Provider-report 60 8.7 ± 1.0 48 9.1 ± 1.0 0.4 (0.1, 0.7) .0221 PedsQL-HS, Parent-report 63 96.4 ± 6.5 59 96.1 ± 10.3 −0.5 (−3.1, 2.1) .8483 Measure Baseline Before second session Postintervention Mean changea (95% CI) pb N M ± SD N M ± SD N M ± SD DSTAR-A (Diabetes Strengths) 64 37.0 ± 6.6 53 38.1 ± 5.6 61 39.7 ± 5.8 2.6 (1.1, 4.1) .0003 DSMP-SR (Adherence), Adolescent-report 62 52.5 ± 10.3 59 56.9 ± 10.1 4.4 (1.8, 6.9) .0012 DSMP-SR (Adherence), Parent-report 63 54.4 ± 9.2 53 55.2 ± 9.5 59 56.9 ± 10.0 1.9 (−0.7, 4.5) .2051 Blood glucose monitoring adherence 58 3.6 ± 1.4 53 3.7 ± 1.8 0.07 (−0.3, 0.5) .7260 Glycemic control (HbA1c) 62 8.6 ± 1.6 59 8.5 ± 1.6 0.11 (−0.1, 0.4) .3682 PAID-T (diabetes burden), Adolescent-report 64 68.6 ± 28.0 61 61.6 ± 23.6 −5.5 (−10.1, −.0.8) .0231 PAID-PR (diabetes burden), Parent-report 64 71.3 ± 25.2 59 64.6 ± 20.3 −6.5 (−10.9, −2.0) .0050 DFCS-R (diabetes family conflict), Adolescent-report 62 25.5 ± 5.7 60 24.3 ± 4.8 −1.3 (−2.3, −0.4) .0058 DFCS-R (diabetes family conflict), Parent-report 64 24.7 ± 4.8 58 24.9 ± 4.6 −0.1 (−0.9, 0.7) .8429 Adolescent–provider relationship, Adolescent-report 62 7.9 ± 1.6 56 8.5 ± 1.8 0.6 (0.1, 1.1) .0185 Provider–family relationship, Provider-report 60 8.7 ± 1.0 48 9.1 ± 1.0 0.4 (0.1, 0.7) .0221 PedsQL-HS, Parent-report 63 96.4 ± 6.5 59 96.1 ± 10.3 −0.5 (−3.1, 2.1) .8483 a Mean change (between baseline and postintervention) was estimated by the general linear mixed model adjusting for diabetes duration except for PedsQL-HS. The mean change in PedsQL-HS score is summarized for the n = 57 parents with baseline and postintervention assessment measures and p-value estimated using the Wilcoxon signed rank test. CI = confidence interval; DFCS-R = Diabetes Family Conflict Scale Revised; DSMP-SR = Diabetes Self-Management Profile Self-Report; DSTAR-A = Diabetes Strengths and Resilience measure for Adolescents; PedsQL-HS = Pediatric Quality of Life Inventory Healthcare Satisfaction; PAID-PR = Problem Areas in Diabetes measures for parents; PAID-T = Problem Areas in Diabetes measures for adolescents. b p values adjusted using Tukey–Kramer method for multiple comparisons within each measure. Table I. Participant Scores at Baseline, Before the Second Intervention Session, and Postintervention Measure Baseline Before second session Postintervention Mean changea (95% CI) pb N M ± SD N M ± SD N M ± SD DSTAR-A (Diabetes Strengths) 64 37.0 ± 6.6 53 38.1 ± 5.6 61 39.7 ± 5.8 2.6 (1.1, 4.1) .0003 DSMP-SR (Adherence), Adolescent-report 62 52.5 ± 10.3 59 56.9 ± 10.1 4.4 (1.8, 6.9) .0012 DSMP-SR (Adherence), Parent-report 63 54.4 ± 9.2 53 55.2 ± 9.5 59 56.9 ± 10.0 1.9 (−0.7, 4.5) .2051 Blood glucose monitoring adherence 58 3.6 ± 1.4 53 3.7 ± 1.8 0.07 (−0.3, 0.5) .7260 Glycemic control (HbA1c) 62 8.6 ± 1.6 59 8.5 ± 1.6 0.11 (−0.1, 0.4) .3682 PAID-T (diabetes burden), Adolescent-report 64 68.6 ± 28.0 61 61.6 ± 23.6 −5.5 (−10.1, −.0.8) .0231 PAID-PR (diabetes burden), Parent-report 64 71.3 ± 25.2 59 64.6 ± 20.3 −6.5 (−10.9, −2.0) .0050 DFCS-R (diabetes family conflict), Adolescent-report 62 25.5 ± 5.7 60 24.3 ± 4.8 −1.3 (−2.3, −0.4) .0058 DFCS-R (diabetes family conflict), Parent-report 64 24.7 ± 4.8 58 24.9 ± 4.6 −0.1 (−0.9, 0.7) .8429 Adolescent–provider relationship, Adolescent-report 62 7.9 ± 1.6 56 8.5 ± 1.8 0.6 (0.1, 1.1) .0185 Provider–family relationship, Provider-report 60 8.7 ± 1.0 48 9.1 ± 1.0 0.4 (0.1, 0.7) .0221 PedsQL-HS, Parent-report 63 96.4 ± 6.5 59 96.1 ± 10.3 −0.5 (−3.1, 2.1) .8483 Measure Baseline Before second session Postintervention Mean changea (95% CI) pb N M ± SD N M ± SD N M ± SD DSTAR-A (Diabetes Strengths) 64 37.0 ± 6.6 53 38.1 ± 5.6 61 39.7 ± 5.8 2.6 (1.1, 4.1) .0003 DSMP-SR (Adherence), Adolescent-report 62 52.5 ± 10.3 59 56.9 ± 10.1 4.4 (1.8, 6.9) .0012 DSMP-SR (Adherence), Parent-report 63 54.4 ± 9.2 53 55.2 ± 9.5 59 56.9 ± 10.0 1.9 (−0.7, 4.5) .2051 Blood glucose monitoring adherence 58 3.6 ± 1.4 53 3.7 ± 1.8 0.07 (−0.3, 0.5) .7260 Glycemic control (HbA1c) 62 8.6 ± 1.6 59 8.5 ± 1.6 0.11 (−0.1, 0.4) .3682 PAID-T (diabetes burden), Adolescent-report 64 68.6 ± 28.0 61 61.6 ± 23.6 −5.5 (−10.1, −.0.8) .0231 PAID-PR (diabetes burden), Parent-report 64 71.3 ± 25.2 59 64.6 ± 20.3 −6.5 (−10.9, −2.0) .0050 DFCS-R (diabetes family conflict), Adolescent-report 62 25.5 ± 5.7 60 24.3 ± 4.8 −1.3 (−2.3, −0.4) .0058 DFCS-R (diabetes family conflict), Parent-report 64 24.7 ± 4.8 58 24.9 ± 4.6 −0.1 (−0.9, 0.7) .8429 Adolescent–provider relationship, Adolescent-report 62 7.9 ± 1.6 56 8.5 ± 1.8 0.6 (0.1, 1.1) .0185 Provider–family relationship, Provider-report 60 8.7 ± 1.0 48 9.1 ± 1.0 0.4 (0.1, 0.7) .0221 PedsQL-HS, Parent-report 63 96.4 ± 6.5 59 96.1 ± 10.3 −0.5 (−3.1, 2.1) .8483 a Mean change (between baseline and postintervention) was estimated by the general linear mixed model adjusting for diabetes duration except for PedsQL-HS. The mean change in PedsQL-HS score is summarized for the n = 57 parents with baseline and postintervention assessment measures and p-value estimated using the Wilcoxon signed rank test. CI = confidence interval; DFCS-R = Diabetes Family Conflict Scale Revised; DSMP-SR = Diabetes Self-Management Profile Self-Report; DSTAR-A = Diabetes Strengths and Resilience measure for Adolescents; PedsQL-HS = Pediatric Quality of Life Inventory Healthcare Satisfaction; PAID-PR = Problem Areas in Diabetes measures for parents; PAID-T = Problem Areas in Diabetes measures for adolescents. b p values adjusted using Tukey–Kramer method for multiple comparisons within each measure. PAID-T and PAID-PR scores significantly improved from baseline to postintervention. PAID-T scores decreased by 5.5 point (95% CI = −10.1, −0.8) and PAID-PR scores by 6.5 points (95% CI = −10.9, −2.0). Adolescent-reported DFCS-R scores decreased by 1.3 points (95% CI = −2.3, −0.4; p < .01), but parent-reported scores did not change (p = .84). Adolescents’ and providers’ ratings of their relationship increased by 0.6 (95% CI = 0.1, 1.1, p = .02) and 0.4 (95% CI = 0.1, 0.7; p = .02) points, respectively. Parents’ PedsQL-HS scores did not change (p = .85). Few adverse events occurred while participants were part of the study. Four participants had emergency department visits, two for diabetic ketoacidosis and two for reasons not related to diabetes. Two of the emergency visits resulted in one-night hospital admissions. Discussion Pilot data from the Diabetes Strengths Study support preliminary feasibility and acceptability of this brief, strengths-based, clinic-integrated intervention for adolescents with T1D. Recruitment and retention rates >70% support the feasibility of conducting this intervention research with a diverse sample of adolescents in a busy ambulatory diabetes clinic. Overwhelmingly, positive feedback from adolescents, parents, and providers indicates that the intervention was well received and has potential for further study and possibly eventual dissemination in practice without disruption to clinic flow. Preliminary evidence of change in behavioral outcomes suggests this strengths-based intervention may hold promise to enhance patient–provider relationships and positive diabetes-related youth behaviors and attitudes during the vulnerable adolescent years. Participant attrition in study activities was largely because of changes in provider clinical schedules limiting opportunities for study visits, including one provider who retired during the study period. To increase the pool of eligible participants, recruitment was expanded to include diabetes clinic appointments with the remaining participating providers at an additional clinic location. In the future, training more providers in the intervention and allowing the intervention to be delivered by different providers at each clinic appointment would increase flexibility of scheduling and delivering intervention visits more consistently, which would likely enhance retention. Despite the intervention usually taking 5–10 min during already busy clinic appointments and the time required for completing the previsit intervention questionnaires, all providers and most participants reported the time it took was worthwhile for the benefit gained from the intervention. The providers adhered to the intervention components, and there were no complaints about study activities interfering with clinic flow, suggesting few barriers to implementation in busy clinic settings. Providers enjoyed delivering the intervention, and most parents and adolescents gave positive feedback about how the strengths conversations impacted their feelings about diabetes, self-management behaviors, and experiences during clinical encounters. Preliminary change in adolescent-reported behavioral and emotional outcomes was encouraging, with improvements in diabetes strengths, adherence behaviors, family conflict, and burden. This may reflect true change in these constructs or an overall impact of increased positive affect (Lord, Rumburg, & Jaser, 2015) after the intervention, which was not measured. In contrast, the only parent-reported measure that changed was diabetes burden. This may be because of increased awareness of their adolescent doing diabetes-related tasks well or relief and confidence about their adolescent’s self-management skills, as described in the interviews. The lack of change in other constructs may reflect that the intervention targeted adolescents directly (parents’ role was intended to be more as an observer) and/or a problem accurately measuring adolescents’ emotional and behavioral experiences via parent-report. While parent-reported adolescent adherence did not change from baseline to postintervention, the significant change between the second time point (before the second intervention session) and postintervention may suggest that a larger dose of this intervention changes parents’ perspectives on their adolescents’ behavior. It may also be an artifact of the smaller sample size with data from the postbaseline data points, and conclusions about change in adherence behaviors between the second time point and postintervention must be interpreted cautiously, given the short time between the two assessments. There were also improvements in adolescent- and provider-reports of their relationships, suggesting potential benefits of enhancing providers’ communication styles and focus on adolescent strengths. These relationships are important to encourage in adolescence, given evidence of associations with treatment adherence (Taylor, La Greca, Valenzuela, Hsin, & Delamater, 2016) and implications for transition to adult care (Monaghan, Hilliard, Sweenie, & Riekert, 2013). While parent-reported satisfaction with the provider did not change, this may be because of a ceiling effect limiting room for improvement on the PedsQL-HS measure. The lack of change in objectively measured blood glucose monitoring adherence and HbA1c suggests that the intervention as delivered may not have been targeted or intensive enough to directly impact these outcomes. A larger intervention dose, adding booster contacts between clinic appointments, and/or integrating behavioral intervention components to reduce barriers to blood glucose monitoring or other adherence behaviors that more proximally impact HbA1c may increase the impact. The lack of a control group is the biggest limitation. While a single-arm design is appropriate for research on newly developed interventions (Czajkowski et al., 2015) and the primary aims of studying feasibility and acceptability were achieved, definitive conclusions cannot be drawn about the impact of the intervention on the clinical, behavioral, or emotional outcomes evaluated without a comparison condition. The loss of participants to follow-up at various points in the study also raises questions about generalizability, and larger trials of this intervention will need to integrate lessons learned from this pilot study to reduce attrition. However, the sample’s diversity and mean HbA1c similar to national averages increase the potential relevance of findings to a wide proportion of the population of adolescents with T1D and increase the likely relevance and acceptability of this strengths-based approach for youth across racial and ethnic backgrounds. The internal consistency estimates of the DSMP-SR parent- and youth-report questionnaires were relatively lower than was reported in the measures’ validation study (Wysocki et al., 2012), which may indicate more variability in how participants in the current study responded to the items. However, the α coefficients were in the acceptable range. Finally, the selection of providers with an expressed interest in behavioral research, most of whom were nurse practitioners (who often have more psychosocial training and longer appointment times at the institution where the study took place), may limit how this intervention would be delivered by other providers. Future research with more physicians and other health-care professionals is needed to determine how the intervention can be effectively delivered by providers from different training backgrounds. Future study may also evaluate whether delivering the intervention impacts the providers, such as reducing burnout or increasing their self-efficacy. In sum, this brief strengths-based behavioral intervention delivered in diabetes outpatient clinics has the potential to enhance clinical approaches for providers to identify and reinforce what adolescents are doing well for their T1D as part of routine care. Its brevity and integration with existing clinical processes indicate high potential for translatability to a busy ambulatory practice, and the positive feedback and encouraging preliminary outcomes indicate a good deal of promise. Integration of the intervention into clinic flow, such as by sharing the Diabetes Strengths Profiles with providers and families via the electronic medical record, may be helpful considerations for implementation in practice. These preliminary findings add to the growing body of research supporting both strengths-based intervention approaches for adolescents with T1D (Yi-Frazier et al., 2015; Jaser et al., 2014) and brief, clinic-integrated interventions delivered by providers as part of routine care (Monaghan et al., 2015; De Wit et al., 2008). In the future, the impact of this brief intervention may be enhanced through additional intervention contacts (e.g., booster support via telephone or mHealth app) or by integrating the provider-delivered intervention with other empirically supported behavioral intervention strategies. Further study in a fully powered randomized controlled clinical trial is warranted. 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TI - Featured Article: Strengths-Based, Clinic-Integrated Nonrandomized Pilot Intervention to Promote Type 1 Diabetes Adherence and Well-Being
JF - Journal of Pediatric Psychology
DO - 10.1093/jpepsy/jsy051
DA - 2019-01-01
UR - https://www.deepdyve.com/lp/oxford-university-press/featured-article-strengths-based-clinic-integrated-nonrandomized-pilot-ybc6WDhuZf
SP - 5
VL - 44
IS - 1
DP - DeepDyve
ER -