A pilot, single-arm feasibility study of an integrated cognitive-behavioral treatment for anxiety in young autistic children.

OBJECTIVE: Anxiety is prevalent in young autistic children under 7 years of age. Yet there is a paucity of empirically based interventions for this age group. DINO Strategies for Anxiety and Uncertainty Reduction (DINOSAUR) is an innovative cognitive behavioral intervention that seeks to optimize treatment response in young autistic children by targeting anxiety and the contributing mechanisms of intolerance of uncertainty and parental accommodation using a telehealth delivery model. This pilot, single-arm study examines the preliminary feasibility of DINOSAUR. METHODS: Fourteen autistic children ages 4-6 years with average language and cognitive skills and their parents received the intervention. Quantitative and qualitative data pertaining to parent satisfaction and treatment outcomes were collected. RESULTS: Attendance, retention, and parent satisfaction ratings offer preliminary support for the feasibility of the treatment model. Change in clinical severity ratings on a semi-structured parent interview of anxiety and parents' qualitative report suggests the potential to benefit young autistic children. CONCLUSIONS: Results support future study of the DINOSAUR model in a larger, randomized controlled trial.

Mindfulness-based group intervention for adolescents with type 1 diabetes: initial findings from a pilot and feasibility randomized controlled trial.

OBJECTIVE: To evaluate feasibility/acceptability of a virtual, group mindfulness-based intervention (MBI) adapted for pediatric type 1 diabetes (T1D). METHODS: This two-way controlled trial randomized adolescents 1:1 to MBI (n = 20) or health education (HE; n = 22) groups lasting 6-7 weeks. Eligibility included 12-17 years, T1D ≥ 1 year, and elevated scores on PROMIS depression or anxiety measures. Recruitment, retention, and session attendance were tracked to measure feasibility. Acceptability was measured via youth-reported post-session surveys. Adolescents completed depression, anxiety, and diabetes-specific surveys at baseline, immediately post-program, and 3 months post-program completion. HbA1c values approximating these timeframes were obtained from chart review. RESULTS: 55% of screened participants were eligible to participate, and 100% of eligible youth enrolled. There was 93% study retention and 96% session attendance rates. Survey data were 100% complete at baseline, and 93% complete at post-program and 3-month follow-ups; 83% and 78% of MBI participants rated sessions as at least somewhat enjoyable and helpful, respectively, and 91% and 82% of HE participants rated sessions as at least somewhat enjoyable and helpful, respectively. Mean scores showed declines in depression, anxiety, disordered eating, diabetes distress, and HbA1c in both groups across time, with trends toward potential greater reductions in depression and HbA1c in MBI. CONCLUSIONS: This pilot provides preliminary evidence that virtual MBI and HE groups adapted for adolescents with T1D are feasible to deliver and acceptable, with potential improvement in psychosocial, behavioral, and diabetes-specific outcomes. Whether MBI is more effective for targeting negative affect and glycemic control in the context of adolescent T1D requires testing in a full-scale efficacy trial.

Promoting Alcohol Reduction in Non-Treatment Seeking parents (PAReNTS): a pilot feasibility cluster randomized controlled trial of brief alcohol interventions with parents in contact with child safeguarding services.

Many parents who come into contact with early help and children's social care services are risky drinkers. This study aimed to investigate the feasibility and acceptability of conducting a trial of brief alcohol interventions within this setting. We conducted a three-arm pilot feasibility cluster randomised controlled trial in the North-East of England. The additive interventions were: i) screening and a healthy lifestyle leaflet (control); ii) brief advice; iii) extended brief intervention. The trial was later reduced to two-arm due to the extended brief intervention being infeasible. Of the 1769 parents that were approached, 429 consented to be screened (24%), the majority were eligible to participate (n = 415; 97%), 147 of which (35%) scored ≥5 on the AUDIT-C screening tool. There were 108 parents (74%) who consented to participate in the trial (n = 50 control; n = 58 brief advice). Follow-up rates at 6 and 12-months were 61% and 43%. The TLFB30 was found to be a suitable tool to measure the primary outcome of heavy episodic drinking. Qualitative data showed that parents and practitioners largely found trial procedures to be acceptable, however, care should be taken when discussing alcohol risk with parents in this setting. Most of the a-priori success criteria were met in this pilot feasibility trial. The findings suggest that it may be feasible to conduct a two-arm randomised controlled trial of brief alcohol interventions to parents in contact with early help and social care. The TLFB30 was found to be a suitable tool to measure the primary outcome of heavy episodic drinking.

Enhancing Adherence to Antiretroviral Therapy Among Adolescents Living With HIV Through Group-Based Therapeutic Approaches in Uganda: Findings From a Pilot Cluster-Randomized Controlled Trial.

OBJECTIVE: We examine the preliminary impact of group-cognitive behavioral therapy (G-CBT) versus a family-strengthening intervention delivered via multiple family group (MFG) in improving ART adherence among adolescents living with HIV (ALHIV) in Uganda. METHODS: We analyzed data from a pilot cluster-randomized trial (2020-2022) conducted in 9 clinics in Uganda among 89 participants, who were eligible out of the 147 ALHIV screened. Participants were eligible if they were aged 10-14 years, HIV positive, taking ART, and living with a family. Adolescents were randomized, at the clinic level, to receive the usual care (n = 29), MFG (n = 34), or G-CBT (n = 26). The interventions were delivered over 3 months. Overall, the mean percentage attendance for the 10 G-CBT and MFG sessions was 87.7% and 90.2%, respectively. Three ALHIV were lost to follow-up, while 1 child died. Adherence was assessed using pharmacy records collected at baseline and 4 additional pharmacy visits. We used mixed-effects logistic regression analysis to examine the effect of the interventions on ART adherence. RESULTS: We found statistically significant main effects for the intervention, χ2(2) = 7.76, p = .021, time, χ2(2) = 39.67, p < .001, and intervention-time interaction effect χ2(6)= 27.65, p < .001. Pairwise comparisons showed increasing adherence in the MFG group compared to usual care at visit 3 (odds ratio [OR] = 4.52 [1.01-20.11], p = .047) and visit 5 (OR = 3.56 [1.42-8.91], p = .007). Also, compared to usual care, participants who received G-CBT showed higher adherence at visit 4 (OR = 2.69 [1.32-5.50], p = .007). CONCLUSIONS: Our study showed preliminary evidence that G-CBT and MFG might have contributed to improved ART adherence among ALHIV. Moreover, G-CBT is a low-cost alternative to expensive individual therapy, especially in low-resource settings. The results warrant the need for more extensive studies to better understand the role of these interventions in the routine care of ALHIV. The trial is registered at ClinicalTrials.Gov (#NCT04528732).

Delivering ADAPT+ to Latino Families Living in Rural Communities: Feasibility and Acceptability of Implementing a Health Promotion Program Including Mindfulness.

BACKGROUND: Obesity is a major public health crisis in Latino youth. Mounting evidence implicates stress in the development and maintenance of obesity. This study examined the feasibility and acceptability of having community health workers, i.e., promotoras, deliver Adaptando Dieta y Acción Para Todos (ADAPT)+, a family-based health promotion program integrating mindfulness strategies for stress reduction to underserved Latino families in rural communities. METHODS: In an ORBIT model Phase IIb longitudinal quasi-cluster feasibility study, promotoras delivered the 6-session ADAPT+ intervention and 1-session Enhanced Usual Care (EUC) in rural Florida. Feasibility was assessed via sample size and recruitment, randomization by community, data collection completion, and intervention fidelity. Acceptability was assessed via participant retention and program satisfaction. Effect sizes of differences in parent stress and mindful eating between conditions at baseline, end of treatment, and 3-month follow-up were calculated. RESULTS: Feasibility and acceptability were demonstrated. The recruitment target was 99% met (n = 95 recruited). Randomization was limited to site level due to coronavirus disease 2019-related challenges. Data collection procedures were feasible (100% completion). Retention was 86% at post-assessment and 82.6% at 3-month follow-up. All sessions were completed (100% fidelity). Mean program satisfaction was 3.91/4.00. ADAPT+ parents reported lower stress (difference = -3.04, medium-to-large effect, d = .70) and more mindful eating (difference = 2.00, medium effect, d = .44) than EUC parents at 3-month follow-up. CONCLUSION: Study implementation and intervention delivery to rural Latino families using promotoras were feasible and acceptable. Promising findings regarding parent stress and mindful eating support a larger (ORBIT Phase III) efficacy trial. CLINICAL TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov under identifier NCT04800432.

Development and Implementation of a Pilot Transition Preparation Intervention for Young Adults With Type 1 Diabetes in an Integrated Healthcare Setting.

OBJECTIVE: To evaluate the feasibility, acceptability, and preliminary efficacy of a multisystem transition preparation intervention, SHIFT, for young adults (YAs) with type 1 diabetes (T1D). METHODS: A single-arm, clinic-based pilot was conducted with 25 YAs with T1D (M age = 18.9 ± 1.0 years; 80% female), their parents (n = 25), and their providers (n = 10). Young adults and parents participated in a 6-month intervention designed to enhance transition readiness and independent diabetes management. Providers viewed a video module highlighting their role preparing YAs for transition and received individualized reports of YA's goals and transition readiness. Intervention feasibility (i.e., recruitment, retention, and engagement) and acceptability (e.g., program satisfaction) were assessed. Assessments of transition readiness, diabetes engagement, hemoglobin A1c (HbA1c), and related psychosocial variables were conducted at baseline, post-intervention (6 m), and follow-up (9 m). Paired t-tests examined 0-6 m and 0-9 m changes in study constructs. RESULTS: SHIFT was feasible, evidenced by recruitment (100% of sample recruited in 4 m), retention (100% at 6 m), and YA session attendance (100%). Program satisfaction was high for YAs, parents, and providers (9.12 ± 1.40, 8.79 ± 1.56, 8.20 ± 1.30, respectively, [out of 10]). Significant improvements (with effect sizes ranging from small to medium) were observed in parent and YA-reported transition readiness at 6 and 9 m (ps<.05) and diabetes engagement at 9 m (ps<.05). Although based on limited data due to COVID-19-related disruptions, a potential reduction in HbA1c was also observed. CONCLUSION: Findings support the feasibility, acceptability, and preliminary efficacy of SHIFT (although limited by the single arm design and homogeneous sample), and suggest a larger randomized controlled trial is warranted.

Online Intervention for Caregivers of Children with Early Traumatic Brain Injury: Pilot Trial.

OBJECTIVE: To assess the feasibility and acceptability of an online parenting-skills program for caregivers of young children with traumatic brain injury (TBI). Positive parenting contributes to recovery following early TBI and social and emotional development in typically developing children. Yet, few interventions have been designed to support psychosocial recovery and subsequent development after early TBI. METHODS: This study protocol was registered with clinicaltrials.gov (NCT05160194). We utilized an academic hospital's Trauma Registry to recruit caregivers of children, ages 0-4 years, previously hospitalized for TBI. The GROW intervention integrated six online learning modules with videoconference meetings with a coach to review and practice skills while receiving in vivo coaching and feedback. Interactive modules addressed strategies for responsive parenting, stimulating cognition, and managing parenting stress. Enrollment and retention rates served as feasibility metrics and satisfaction surveys assessed acceptability. RESULTS: 18 of 72 families contacted (25%) consented, and 11 of 18 (61%) completed the intervention and follow-up assessments. All participants rated the intervention as helpful and indicated that they would recommend the intervention to others. All endorsed a better understanding of brain injury and how to optimize their child's recovery and development. Both coaches rated intervention delivery as comparable to traditional face-to-face treatment. CONCLUSIONS: Low levels of uptake and initial engagement underscore the challenges of intervening with caregivers following early TBI, which likely were exacerbated due to the COVID-19 pandemic. High levels of acceptability and perceived benefit support the potential utility of GROW while highlighting the need to improve accessibility and early engagement.

Evaluating the Feasibility and Acceptability of the Lifestyle Enhancement for ADHD Program.

OBJECTIVE: To evaluate the feasibility and acceptability of the Lifestyle Enhancement for Attention Deficit Hyperactivity Disorder (ADHD) Program (LEAP), a novel parent behavior management training program that promotes physical activity (PA) and positive health behaviors and is enhanced with mobile health technology (Garmin) and a social media (Facebook) curriculum for parents of children with ADHD. METHODS: The study included parents of children ages 5-10 years diagnosed with ADHD who did not engage in the recommended >60 min/day of moderate to vigorous PA based on parent report at baseline. Parents participated in the 8-week LEAP group and joined a private Facebook group. Children and one parent wore wrist-worn Garmin activity trackers daily. Parents completed the Treatment Adherence Inventory, Client Satisfaction Questionnaire, and participated in a structured focus group about their experiences with various aspects of the program. RESULTS: Of 31 children enrolled, 51.5% had ADHD combined presentation, 36.3% with ADHD, predominately inattentive presentation, and 12.1% had unspecified ADHD (age 5-10; M = 7.6; 48.4% female). Parents attended an average of 86% of group sessions. On average, parents wore their Garmins for 5.1 days/week (average step count 7,092 steps/day) and children for 6.0 days/week (average step count 9,823 steps/day). Overall, parents and children were adherent to intervention components and acceptability of the program was high. CONCLUSIONS: Findings indicate that the LEAP program is an acceptable and feasible intervention model for promoting PA among parents and their children with ADHD. Implications for improving ADHD symptoms and enhancing evidence-based parent training programs are discussed.

Feasibility of Medical Student Mentors to Improve Transition in Sickle Cell Disease.

OBJECTIVE: Advances in medical care have resulted in nearly 95% of all children with sickle cell disease (SCD) living to adulthood. There is a lack of effective transition programming, contributing to high rates of mortality and morbidity among adolescents and young adults (AYAs) during the transition from pediatric to adult healthcare. This nonrandomized study evaluated the feasibility, acceptability, and preliminary outcomes of a novel medical student mentor intervention to improve transition outcomes for AYA with SCD. METHODS: Eligible participants were ages 18-25 years, either preparing for transition or had transferred to adult care within the past year. Twenty-four AYA with SCD (Mage = 20.3, SD = 2.6) enrolled in the program and were matched with a medical student mentor. Feasibility and acceptability of the intervention was assessed through enrollment rates, reasons for refusal, retention rates, engagement with the intervention, satisfaction, and reasons for drop-out. Dependent t-tests were used to evaluate the preliminary effects of the intervention on patient transition readiness, health-related quality of life, self-efficacy, SCD knowledge, medication adherence, and health literacy. RESULTS: Participants (N = 24) demonstrated adequate retention (75.0%), adherence to the intervention (M = 5.3 of 6 sessions), and satisfaction with the intervention components. Participants demonstrated significant improvements in transition readiness (p = .001), self-efficacy (p = .002), medication adherence (p = .02), and health literacy (p = .05). CONCLUSIONS: A medical student mentor intervention to facilitate transition from pediatric to adult care for AYA with SCD is both feasible and acceptable to patients and medical students. Preliminary results suggest benefits for patients, warranting a larger efficacy study.