Psychometric Properties of the Automated Insulin Delivery: Benefits and Burdens Scale for Adults with Type 1 Diabetes.

Objective: To evaluate the psychometric properties of a patient-reported outcome measure, the Automated Insulin Delivery-Benefits and Burdens Scale (AID-BBS), which was designed to assess benefits and burdens of AID use in adults with type 1 diabetes (T1D). The measure was hypothesized to have validity, reliability, and clinical utility for predicting likelihood of continued use of an AID system. Research Design and Methods: A total of 217 adults with T1D (ages from 18 to 82 years) who were enrolled in an AID system research trial completed AID-BBS items at study midpoint (6 weeks) and at the end of the trial (13 weeks). Data were collected on pre-post glycemic outcomes. Participants completed other patient-reported psychosocial outcome measures (e.g., emotional well-being, diabetes distress, attitudes toward diabetes technology, diabetes treatment satisfaction) at Week 13. Likelihood of continued device use was assessed with three items at 13 weeks. Results: Exploratory factor analysis supported a one-factor structure for each subscale (15-item benefit and 9-item burden subscale) when evaluated separately. Convergent, discriminant, and predictive validity, internal consistency, and test-retest reliability were supported. Benefit and burden subscales at week 6 predicted usage intention above and beyond device impact on glycemic outcomes, also controlling for baseline glycemic outcomes. Conclusion: Findings support the AID-BBS as a psychometrically valid, reliable, and useful instrument for assessing burdens and benefits associated with AID system use in adults with T1D. The measure can be used to help health care providers set realistic expectations and proactively address modifiable burdens. Clinical Trial Registration Number: NCT04200313.

Diabetes distress in urban Black youth with type 1 diabetes and their caregivers: associations with glycemic control, depression, and health behaviors.

OBJECTIVES: Adolescents with type 1 diabetes (T1D) and their caregivers endorse high diabetes distress (DD). Limited studies have documented the impact of DD on Black youth. The aims of the present study were to (1) describe DD among a sample of Black adolescents with T1D and their caregivers, (2) compare their DD levels with published normative samples, and (3) determine how DD relates to glycemic outcomes, diabetes self-management, parental monitoring of diabetes, and youth depressive symptoms. METHODS: Baseline data from a multicenter clinical trial were used. Participants (N = 155) were recruited from 7 Midwestern pediatric diabetes clinics. Hemoglobin A1c (HbA1c) and measures of DD, parental monitoring of diabetes care, youth depression and diabetes management behaviors were obtained. The sample was split into (1) adolescents (ages 13-14; N = 95) and (2) preadolescents (ages 10-12; N = 60). Analyses utilized Cohen's d effect sizes, Pearson correlations, t-tests, and multiple regression. RESULTS: DD levels in youth and caregivers were high, with 45%-58% exceeding either clinical cutoff scores or validation study sample means. Higher DD in youth and caregivers was associated with higher HbA1c, lower diabetes self-management, and elevated depressive symptoms, but not with parental monitoring of diabetes management. CONCLUSIONS: Screening for DD in Black youth with T1D and caregivers is recommended, as are culturally informed interventions that can reduce distress levels and lead to improved health outcomes. More research is needed on how systemic inequities contribute to higher DD in Black youth and the strategies/policy changes needed to reduce these inequities.

Testing 3 Digital Health Platforms to Improve Mental Health Outcomes in Adults With Type 1 Diabetes: A Pilot Trial.

OBJECTIVE: Our aim in this study was to examine the potential impact of a 3-pronged digital health pilot intervention (TRIFECTA) on diabetes distress and depressive symptoms among adults with type 1 diabetes (T1D) in British Columbia. METHODS: We recruited 60 adults with T1D (mean age 38.9±15.1 years, 75% female, 77% Caucasian) who participated in the 6-month pilot intervention involving 3 digital health platforms: monthly, provider-led, group-based sessions over Zoom (virtual huddles); a WhatsApp peer texting group; and a web-based "Ask-the-expert" portal. Assessments were conducted at baseline and 6 months and measured diabetes distress (T1D Diabetes Distress Scale), depressive symptoms (9-item Personal Health Questionnaire), and TRIFECTA engagement metrics. RESULTS: Participation in TRIFECTA was associated with significant reductions in Overall Distress (p=0.011) and 4 distress subscales: Powerlessness (p=0.006), Management Distress (p=0.001), Hypoglycemia Distress (p=0.029), and Eating Distress (p<0.001). A higher number of virtual huddles attended predicted lower Overall Distress (p=0.019) and Family/Friends Distress (p=0.023). A higher number of "Ask-the-expert" posts viewed predicted lower Overall Distress (p=0.046), whereas a higher number of WhatsApp messages posted predicted lower Management Distress (p=0.006). Furthermore, engagement in all 3 metrics was a predictor for lower Negative Social Perceptions Distress (p<0.05). No associations were seen in other distress subscales or for depressive symptoms. CONCLUSIONS: Participation in TRIFECTA was linked to reduced diabetes distress levels, but not depressive symptoms, in a platform-dependent manner. This study provides promising pilot data for a subsequent large-scale and fully powered randomized controlled trial.

Universal and Trauma-Specific Care Suggestions for Pediatric Primary Care Settings.

Trauma exposure and other adverse life events are common experiences among youth and present long-standing mental and physical health consequences. Given the ongoing lack of sufficient mental health services, pediatricians play a critical role in supporting trauma-exposed youth. We propose both universal precaution and trauma-specific strategies for pediatric primary care settings. Universal interventions include recommendations to make health care systems more trauma-informed, reduce trauma or re-traumatization in the medical setting, eliminate potential bias, and focus on a strengths-based approach to support diverse youth and families. Trauma-specific strategies include screening for trauma-related symptomatology and risk stratification to link youth to appropriate levels of care. Specific assessment tools, resources, and materials are provided. [Pediatr Ann. 2023;52(11):e418-e421.].

Psychosocial Impact of the Insulin-Only iLet Bionic Pancreas for Adults, Youth, and Caregivers of Youth with Type 1 Diabetes.

Objective: To evaluate the psychosocial impact and user experience for the insulin-only configuration of iLet bionic pancreas (BP) in persons 6-83 years years of age with type 1 diabetes. Research Design and Methods: In this multicenter, randomized controlled, 13-week trial, 275 adults (221 randomly assigned to the BP group and 54 to the standard of care [SC] group) and 165 youth and their caregivers (112 randomly assigned to the BP group and 53 to the SC group) completed psychosocial questionnaires at baseline, mid-study, and the end of the trial. Results: In all age groups, most participants would recommend using the BP, including those with previous experience using automated insulin delivery devices. Similarly, the vast majority of participants reported a high level of perceived benefits and a low number of perceived burdens. Adult participants reported significant decreases in the fear of hypoglycemia and in diabetes-specific emotional distress, as well as improvements in their perceived well-being. Conclusion: Findings demonstrate acceptability, reduced burden, and positive psychosocial outcomes for adults. Children and teenagers also report high acceptability and reduced burden, but less clear improvements in psychosocial outcomes. Clinical Trial Registration Number: NCT04200313.

Disruptions in Lifestyle Habits and Access to Social Support in the Time of COVID-19: Associations With Diabetes Distress and Depression Among Adults With Type 1 Diabetes Living in British Columbia.

OBJECTIVES: In this study, we examined rates of diabetes distress and depressive symptoms in adults with type 1 diabetes (T1D) during the COVID-19 lockdown and its association with disruptions in lifestyle habits and access to social support. METHODS: This cross-sectional investigation included a convenience sample of 60 adults with T1D who completed a survey assessing diabetes distress (Type 1 Diabetes Distress Scale), depressive symptoms (Personal Health Questionnaire-9), and disruptions in lifestyle habits (sleep patterns, dietary patterns, exercise routine) and access to support from family/friends. Linear regression analyses examined COVID-19 disruption variables as predictors of diabetes distress and depressive severity. RESULTS: Seventy-three percent and 38% of participants reported elevated diabetes distress and depressive symptoms, respectively. Greater eating disruption predicted higher depressive symptom severity (ß=1.33, p=0.045) and eating distress (ß=0.28, p=0.045). Greater social support disruption predicted higher eating distress (ß=0.36, p=0.019). CONCLUSIONS: Findings revealed high rates of diabetes distress and depressive symptoms in this T1D sample during the COVID-19 lockdown. Moreover, disruptions in some lifestyle habits and access to social support were associated with worse mental health outcomes.

Comparative analysis of pediatric anxiety measures in clinical sample: evaluation of the PROMIS pediatric anxiety short forms.

OBJECTIVE: Examine the psychometric properties, validity in relation to a legacy measure, and diagnostic accuracy of the PROMIS Anxiety Short Form 2.0 (PROMIS A-SF) Caregiver and Youth Reports in a clinical sample. METHODS: Participants were 301 youth and caregivers referred to a behavioral health clinic by their pediatrician. Participants and their caregivers completed PROMIS A-SF (youth and caregiver proxy), SCARED (youth and caregiver proxy), and a semi-structured interview. Descriptive, correlational, test-retest reliability, and receiver operating characteristic (ROC) analyses were conducted for both measures. RESULTS: PROMIS A-SF measures were highly correlated with SCARED total scores and the panic subscale. PROMIS A-SF measures had AUCs ranging from .49-.79 for the detection of any of three primary subtypes of anxiety: Generalized Anxiety, Separation Anxiety, and Social Anxiety. IMPLICATIONS: Dimensional anxiety subtypes, such as Social Anxiety may not be well detected on the PROMIS youth measure. Use of the PROMIS A-SF as a part of Evidence Based Assessment process is discussed.

Improving diagnostic accuracy: Comparison of nomograms and classification tree analyses for predicting the diagnosis of oppositional defiant disorder.

Unstructured clinical interviews are inaccurate tools for diagnostic decision-making. While structured diagnostic evaluations improve reliability, they are infrequently used in clinical practice. Empirical approaches are a hallmark of evidenced-based assessment and may reduce burdens of structured interviews. We explore two approaches to empirical prediction of diagnosis, the naïve nomogram, and classification tree analysis (CTA). To illustrate the clinical utility of each approach, we compared their use in a sample of 6-year-olds (N = 619) to predict structured-interview diagnoses of oppositional defiant disorder (ODD). Findings indicate the accuracy of both approaches in predicting the absence of a disorder and improved detection of ODD using CTA for subgroups of children. Both empirical prediction techniques have applicability to diagnostic decision-making in psychiatry and pediatrics. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Examining Indirect Effects of Anxiety on Glycated Hemoglobin via Automatic Negative Thinking and Diabetes-Specific Distress in Adolescents With Type 1 Diabetes.

OBJECTIVES: In this study, we examined the indirect effects of anxiety on glycated hemoglobin (A1C) via automatic negative thinking and diabetes distress among adolescents with type 1 diabetes (T1D) during the follow-up interval of a randomized controlled trial of an intervention targeting resilience promotion/depression prevention. METHODS: Adolescents (N=264) participating in the Supporting Teen Problem Solving clinical trial were included and assessed at 8, 12, 16 and 28 months postbaseline. A serial, double-mediation model was used to examine path effects from anxiety to A1C through automatic negative thinking, through diabetes distress and through both automatic negative thinking and diabetes distress. Relevant demographic and clinical covariates were included. RESULTS: Anxiety significantly predicted increases in both automatic negative thinking and diabetes distress. Automatic negative thinking was not found to mediate the association between anxiety and A1C, but diabetes distress did mediate the association. The double-mediation path through automatic negative thinking and diabetes distress together was significant. The indirect effect of anxiety on A1C through diabetes distress was significant and greater than the indirect effect of the double-mediator path. Anxiety did not predict A1C independent of its effects on automatic negative thinking and diabetes distress. Inclusion of demographic covariates did not substantively change the results. CONCLUSIONS: Analyses suggest that automatic negative thinking and diabetes distress mediate the relationship between anxiety and A1C among adolescents with T1D. Diabetes distress appears to be a robust factor linking anxiety to A1C. Diabetes distress should be further examined as a mediator of glycemic variability in anxious youth with T1D.

Psychometric properties of the diabetes skills checklist for adolescents with type 1 diabetes and their parents.

OBJECTIVE: Among adolescents with type 1 diabetes, research has found that their perception of their diabetes management is an important predictor of actual diabetes management. There is a need for measures that assess adolescents' perception of their ability to independently complete daily diabetes self-care tasks. The current study examined the psychometric properties of the Diabetes Skills Checklist Teen-Report (DSC-T) and DSC Parent of Teen-Report (DSC-PT), which assess perceived independence in diabetes self-care skills. RESEARCH DESIGN AND METHODS: Data were from 1450 adolescents aged 12 to 18 years and their parents who participated in the Diabetes Camp Matters Study. Families completed the DSC as well as other questionnaires online assessing demographic and diabetes-related information, diabetes strengths, and diabetes-specific emotional distress. RESULTS: Exploratory factor analysis revealed a 14-item DSC-T and 12-item DSC-PT, both with excellent internal consistency and concurrent validity. Both the DSC-T and DSC-PT were found to be positively correlated with diabetes strengths and negatively correlated with HbA1c, and the DSC-PT was significantly correlated with parent-reported diabetes distress. Adolescents who used insulin pumps and continuous glucose monitoring reported higher perceived independence in diabetes self-care skills compared to adolescents who used insulin pens/syringes or blood glucose meters. No differences were found based on demographic characteristics. CONCLUSIONS: The DSC-T and DSC-PT have strong potential to be used during diabetes clinic visits to spark discussion regarding adolescents' self-care, which would allow for a more successful transfer of diabetes care from parent to adolescent, and eventually, the transition from pediatric to adult healthcare.

Patient-Reported and Parent Proxy-Reported Outcomes in Pediatric Medical Specialty Clinical Settings: A Systematic Review of Implementation.

OBJECTIVE: Youth with chronic illness are at higher risk for psychosocial difficulties, leading to a call for screening via patient-reported outcomes (PROs). The purpose of the current review is to summarize PRO implementation in pediatric medical specialty settings. A literature review of PRO implementation in these settings, conceptual issues, value and approach, legal and ethical concerns, as well as a case example of PROA in type 1 diabetes are presented. METHODS: A systematic review was conducted to identify relevant articles published since the most recent Journal of Pediatric Psychology Special Issue on Evidence-Based Assessment in Pediatric Psychology (2008). RESULTS: Thirty-two articles were identified and reviewed. The majority of studies reported that PROA was feasible, did not disrupt clinic flow, identified psychosocial issues warranting intervention, and was acceptable to families and providers. Response to elevated scores and impact on behavioral health referrals varied. CONCLUSION: While many evidenced-based assessment measures are well-validated within pediatric chronic illness groups, the literature regarding implementation of PROs is still emerging. Research findings are promising, with PROs being feasible, acceptable, and leading to increased discussion of psychosocial issues when integrated into pediatric medical settings. Additional research is needed to evaluate the longitudinal impact of PROs and the optimal manner of responding to assessment data, particularly when clinically-elevated. Ultimately, identifying psychosocial issues in pediatric medical settings can promote optimal health and well-being of youth with chronic illness and their families.

Psychometric Properties of the Parent and Child Problem Areas in Diabetes Measures.

OBJECTIVE: Children with type 1 diabetes and their parents face daily self-care demands, leading to diabetes-specific emotional distress. A standardized measure of diabetes distress can guide clinical care and prevent negative outcomes. METHODS: This study evaluated the psychometric properties of child- and parent-report measures of the Problem Areas in Diabetes Scale, adapted for children ages 8-12 (PAID-C) and their parents (P-PAID-C). Participants were from 42 diabetes camps in the United States. Children (N = 804; mean age = 10.3 ± 1.1) and parents (N = 968) completed measures of diabetes distress, diabetes-related strengths, and self-care skills. Half of the sample was used for exploratory factor analyses (EFA) with direct oblimin rotation and the other half for confirmatory factor analyses (CFAs). RESULTS: For the PAID-C, EFA and CFAs supported an 11-item two-factor measure, Cronbach's α = .91, accounting for 54.6% of the variance. For the P-PAID-C, analyses resulted in a 16-item measure, Cronbach's α = .92, accounting for 51.9% of the variance. PAID-C and P-PAID-C scores were positively correlated with HbA1c (rchild = .08, p = .04; rparent = .18, p < .001), and negatively correlated with diabetes-related strengths (rchild = -.38, p < .001, rparent = -.29, p < .001) and parent report of child self-care skills (rparent = -.13, p < .001; rchild = -0.07, p = ns). CONCLUSIONS: Initial psychometrics suggest that the PAID-C and P-PAID-C reliably and validly capture diabetes-specific emotional distress for children and their parents. Associations with glycemic control, self-care, and diabetes strengths demonstrate criterion validity. Both measures have potential applications for routine, clinic-based assessments of diabetes distress and may guide clinical decision-making.

Diabetes camp still matters: Relationships with diabetes-specific distress, strengths, and self-care skills.

OBJECTIVE: Prior studies suggest diabetes camps improve psychosocial well-being in youth with type 1 diabetes but these studies suffer from variable levels of rigor. The present study assessed associations between camp participation and diabetes distress, perceived independence in diabetes self-care, and diabetes strengths in a large sample of children, adolescents, and their parents across 44 camps in the United States. Analyses compared viewpoints of study participants, identified moderators of change, and assessed perceived benefits of camp participation. METHODS: There were 2488 youth and 2563 parents consented for participation in the online survey. Participants reported diabetes distress and perceived independence in youth care, their new experiences and best parts of camp, and changes in behavior following camp. T-tests, regressions, Cohen's d, and relative frequencies were used as appropriate to assess baseline differences between reporters, pre-post outcome differences, and moderators of change. RESULTS: Parents as compared to youth reported higher pre-camp distress and lower perception of youth independence in self-care. Youth experienced a statistically significant decrease in distress and increase in independence in self-care. Diabetes strengths did not change. Higher A1c prior to camp was associated with higher levels of distress across camp participation. Campers and their parents endorsed a high frequency of positive firsts, bests, and benefits of camp. CONCLUSIONS: Data from a large sample youth with type 1 diabetes across multiple camps showed broad-based psychosocial benefits of camp participation.

Pilot Randomized Controlled Trial of Omega-3 and Individual-Family Psychoeducational Psychotherapy for Children and Adolescents With Depression.

The goal of this study is to evaluate feasibility and estimate effect sizes of omega-3 fatty acids (Ω3), individual-family psychoeducational psychotherapy (PEP), their combination, and moderating effects of maternal depression and psychosocial stressors in youth with depression. In a pilot 2 × 2 randomized controlled trial, 72 youth (ages 7-14; 57% Caucasian, 57% male) with major depression, dysthymia, or depression not otherwise specified were randomized to 12 weeks of Ω3, PEP+placebo, Ω3+PEP, or placebo. Ω3 versus placebo was double-masked. Evaluators masked to condition assessed depressive severity at baseline (randomization) and at 2, 4, 6, 9, and 12 weeks using the Children's Depression Rating Scale-Revised. Side effects were either absent or mild. PEP was administered with 74% fidelity. Remission was 77%, Ω3+PEP; 61%, PEP+placebo; 44%, Ω3; 56%, placebo. Intent-to-treat analyses found small to medium effects of combined treatment (d = .29) and Ω3 monotherapy (d = .42), but negligible effect for PEP+placebo (d < .10), all compared to placebo alone. Relative to placebo, youth with fewer social stressors responded better to Ω3 (p = .04), PEP (p = .028), and their combination (p = .035), and those with maternal depression responded better to PEP (p = .020) than did those without maternal depression. Remission rates were favorable compared to other studies of psychotherapy and comparable to an existing randomized controlled trial of Ω3; results warrant further evaluation in a larger sample. Ω3 was well tolerated. Active treatments show significantly more placebo-controlled depression improvement in the context of maternal depression and fewer stressors, suggesting that they may benefit depression with a more endogenous than environmental origin.

Predicting Therapeutic Effects of Psychodiagnostic Assessment Among Children and Adolescents Participating in Randomized Controlled Trials.

This study explored predictors of improvement after completing a psychodiagnostic screening assessment but before randomization among youth who participated in two pilot randomized controlled trials of omega-3 supplementation and Individual-Family Psychoeducational Psychotherapy (PEP). Ninety-five youth (56.8% male, 61.1% White) ages 7-14 with mood disorders completed screening and baseline assessments (including Clinical Global Impressions-Improvement [CGI-I], Children's Depression Rating Scale-Revised, Young Mania Rating Scale), then were randomized into a 12-week trial of omega-3, PEP, their combination, or placebo. Between screening and randomization, 35.8% minimally improved (CGI-I = 3), 12.6% much improved (CGI-I < 3), totaling 48.4% improved. Caregiver postsecondary education (p = .018), absence of attention-deficit/hyperactivity disorder (p = .027), and lower screen depression severity (p = .034) were associated with CGI-I. Caregiver postsecondary education (p = .020) and absence of a disruptive behavior diagnosis (p = .038) were associated with depression severity improvement. Prerandomization improvement moderated treatment outcomes: Among youth who improved prerandomization, those who received PEP (alone or with omega-3) had more favorable placebo-controlled depression trajectories due to a lack of placebo response. This open-label trial of psychodiagnostic assessment provides suggestive evidence that psychodiagnostic assessment is beneficial, especially for those with depression and without externalizing disorders. Prerandomization improvement is associated with better placebo-controlled treatment response. Future research should test alternative hypotheses for change and determine if less intensive (shorter and/or automated) assessments would provide comparable results.

Parent-adolescent dyadic diabetes distress: Associations with A1c and diabetes-related strengths.

INTRODUCTION: This study examined concordance and discordance between parent-adolescent report of diabetes-specific emotional distress and associations with A1c and diabetes-related strengths. Diabetes strengths refer to adaptive behaviors and attitudes that enhance resilience in living with diabetes. METHOD: One thousand two hundred sixteen adolescent-parent dyads completed measures of diabetes distress and adolescent-reported diabetes strengths. Polynomial regression with response surface analysis assessed concordant and discordant reports of adolescent-parent distress and independent associations of each reporter's distress on measures of diabetes strengths and A1c. RESULTS: A1c was lower in concordantly lower distress dyads compared to concordantly higher distress dyads. For discordant dyadic reports, A1c was higher when distress was higher for parents and lower for adolescents compared to low-parent-high-adolescent distress. Greater diabetes-related strengths were reported when distress was concordantly low among dyads and fewer strengths were reported when distress was concordantly higher. Greater strengths were reported when distress was lower for adolescents and higher for parents compared to high-adolescent/low-parent distress. Dyadic distress for both A1c and diabetes strengths were robust when adjusted for significant demographic predictors of outcome including age, race, income, pump use, and continuous glucose monitoring use. DISCUSSION: A1c and diabetes strengths are associated with degree of concordant and discordant reports of diabetes distress among adolescent-parent dyads. Programmatic interventions should target parents and adolescents, particularly when diabetes distress is higher among both adolescents and their parents. (PsycINFO Database Record

Continuous Glucose Monitoring Associated With Less Diabetes-Specific Emotional Distress and Lower A1c Among Adolescents With Type 1 Diabetes.

BACKGROUND: Psychosocial impact research of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) among adolescents with type 1 diabetes (T1D) is limited. The present study assesses associations between diabetes technology use on adolescent- and parent-perceived diabetes-specific distress and A1c. METHOD: Adolescents with T1D and parents (N = 1040; primarily mothers) completed measures of diabetes distress. Adolescents were categorized by technology use: CGM Alone, CSII Alone, CGM+CSII, or No Technology. ANOVA, regression, and Cohen's d were used for group comparisons on measures of diabetes distress and A1c. Analyses also compared groups on clinical elevations of distress. RESULTS: CGM use was associated with less adolescent distress compared to No Technology ( d = 0.59), CGM+CSII ( d = 0.26), and CSII Alone ( d = 0.29). Results were similar but with smaller effect size for parent-reported distress, although CGM+CSII showed equivocal association with parent distress compared to No Technology ( d = 0.18). CGM Alone was associated with lower A1c compared to No Technology ( d = 0.48), to CSII Alone ( d = 0.37), and was comparable to CGM+CSII ( d = 0.03). CGM+CSII conferred advantage over CSII Alone ( d = 0.34). Clinical elevation of distress was associated with not using any technology particularly for adolescents. CONCLUSIONS: Technology use is associated with lower adolescent distress than lower parent distress. CGM Alone is associated with lower adolescent and parent distress than CSII or CGM+CSII. This appears to be clinically meaningful based on cut scores for measures. CGM is associated with lower A1c independent of being used alone or with CSII.

Psychometric Properties of the Problem Areas in Diabetes: Teen and Parent of Teen Versions.

Objective: This study adds to the literature on the psychometric properties of the Problem Areas in Diabetes-Teen (PAID-T) and Parent (P-PAID-T) Versions. It also aims to shorten the measures of diabetes-specific distress, determine construct validity, and establish cutoff scores. Methods: Data are from two independent studies (N = 1,265). Adolescent-caregiver dyads completed measures of emotional distress, diabetes strengths, hemoglobin A1c, blood glucose checks, and average blood glucose. Exploratory and confirmatory factor analyses assessed factor structures for each measure. Correlational analyses provided support for concurrent validity. Receiver-operating characteristic curves identified cutoff scores based on clinically meaningful groups identified with latent profile analysis. Results: Analyses supported a 14-item PAID-T and a 15-item P-PAID-T, with preliminary cutoff scores ≥44 and ≥54, respectively. Measures were associated with emotional and health outcomes as hypothesized. Conclusions: The PAID-T and P-PAID-T are valid, reliable, and useful measures of diabetes-specific distress for teenagers with type 1 diabetes and parents of teenagers.

Omega-3 supplementation associated with improved parent-rated executive function in youth with mood disorders: secondary analyses of the omega 3 and therapy (OATS) trials.

BACKGROUND: Improvements in executive functioning (EF) may lead to improved quality of life and lessened functional impairment for children with mood disorders. The aim was to assess the impact of omega-3 supplementation (Ω3) and psychoeducational psychotherapy (PEP), each alone and in combination, on EF in youth with mood disorders. We completed secondary analyses of two randomized controlled trials (RCTs) of Ω3 and PEP for children with depression and bipolar disorder. METHODS: Ninety-five youths with depression or bipolar disorder not otherwise specified/cyclothymic disorder were randomized in 12-week RCTs. Two capsules (Ω3 or placebo) were given twice daily (1.87 g Ω3 total daily, mostly eicosapentaenoic acid). Families randomized to PEP participated in twice-weekly 50-min sessions. Analyses assess impact of interventions on the Behavior Rating Inventory of Executive Functioning (BRIEF) parent-report Global Executive Composite (GEC) and two subscales, Behavior Regulation (BRI) and Metacognition (MI) Indices. Intent-to-treat repeated measures ANOVAs, using multiple imputation for missing data, included all 95 randomized participants. Trials were registered with www.clinicaltrials.gov, NCT01341925 & NCT01507753. RESULTS: Participants receiving Ω3 (aggregating combined and monotherapy) improved significantly more than aggregated placebo on GEC (p = .001, d = .70), BRI (p = .004, d = .49), and MI (p = .04, d = .41). Ω3 alone (d = .49) and combined with PEP (d = .67) each surpassed placebo on GEC. Moderation by attention-deficit/hyperactivity disorder (ADHD) comorbidity was nonsignificant although those with ADHD showed nominally greater gains. PEP monotherapy had negligible effect. CONCLUSIONS: Decreased impairment in EF was associated with Ω3 supplementation in youth with mood disorders. Research examining causal associations of Ω3, EF, and mood symptoms is warranted.

A Randomized Controlled Trial of Individual Family Psychoeducational Psychotherapy and Omega-3 Fatty Acids in Youth with Subsyndromal Bipolar Disorder.

OBJECTIVE: This pilot study evaluates efficacy of omega-3 fatty acid supplementation (Ω3), individual family psychoeducational psychotherapy (IF-PEP), and their combination in youth with subsyndromal bipolar disorders (bipolar disorder not otherwise specified [BP-NOS], cyclothymic disorder [CYC]). METHODS: This study was a 12 week, randomized trial of Ω3 versus placebo and IF-PEP versus active monitoring (AM) using a 2 × 2 design (Ω3 + PEP: n = 5; Ω3 + AM: n = 5; placebo + PEP: n = 7; placebo + AM: n = 6). Twenty-three youth ages 7-14 with BP-NOS or CYC were recruited via community advertisements and clinician referrals. Participants could be taking stable medication for attention-deficit/hyperactivity disorder and sleep aids, but no other psychotropics. Independent evaluators assessed participants at screen, baseline, and 2, 4, 6, 9, and 12 weeks. Primary outcome measures were the Kiddie Schedule for Affective Disorders (K-SADS) Depression (KDRS) and Mania (KMRS) Rating Scales, Children's Depression Rating Scale-Revised (CDRS-R), and Young Mania Rating Scale (YMRS). Ω3/placebo conditions were double-blind; independent evaluators were blind to psychotherapy condition. RESULTS: Most participants (83%) completed the 12 week trial. Side effects were uncommon and mild. Intent-to-treat analyses indicated significant improvement in depressive symptoms (KDRS) for combined treatment relative to placebo and AM (p = 0.01, d = 1.70). Across groups, manic symptoms improved over time without significant treatment effects. Effect of IF-PEP on child depression compared with AM was medium (d = 0.63, CDRS-R) to large (d = 1.24, KDRS). Effect of Ω3 on depression was medium (d = 0.48, KDRS). CONCLUSION: IF-PEP and Ω3 are well tolerated and associated with improved mood symptoms among youth with BP-NOS and CYC. Clinicaltrials.gov Identifier: NCT01507753.