NCT06725186

Regulating Emotions Like An eXpert Among Adolescents With ADHD

Improving Emotion Dysregulation and Interpersonal Conflict Among Families of Adolescents With ADHD

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Virginia Polytechnic Institute and State University · Academic / Other
• Sex: All
• Age: 11 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

This study consists of a randomized controlled trial assessing the acceptability, feasibility, and efficacy of the RELAX (Regulating Emotions Like An eXpert) Intervention. Following randomization, 30 families will receive the RELAX intervention and 30 families will receive psychoeducational materials as part of a control condition. Additionally, 10 families from the RELAX condition will participate in a pilot study and focus groups to give feedback on developed smartphone apps to support skill use during and following completion of RELAX.

Detailed description

This study seeks to quantify the efficacy of the telehealth RELAX intervention (n = 30) relative to a psychoeducational waitlist control (PWL; n = 30) through a RCT. The psychoeducational component will consist of infographics for parents and adolescents regarding ER strategies, parent emotion socialization, and managing interpersonal conflict. Participants will be 60 adolescents with ADHD in middle or high school (ages 11-16) who display moderate to severe emotion dysregulation as measured by the Difficulties in Emotion Regulation Scale, and a primary caregiver. Adolescents will have an estimated verbal IQ ≥ 80, as indicated by the Wechsler Intelligence Scale for Children, Fifth Edition Verbal Comprehension Index, with no evidence of severe developmental delay. All participants must be proficient in English. Adolescents may have comorbid conditions, so the sample will represent real-world adolescents with ADHD. Ten families who complete the RELAX intervention will be asked to participate in the ecological momentary intervention (EMI) pilot study which will assess the developed EMI procedure's acceptability, appropriateness, and feasibility of using smartphone apps to practice the skills learned during RELAX both during the original 8 weekly sessions and throughout the 6 month follow-up period using Likert-ratings. Additionally, they will be asked if they are interested in accessing the mobile apps for a 4-week period to continue practicing the skills learned in RELAX and to provide more in-depth feedback on the app to the research team via a 1-hour focus group.

Conditions

• RELAX Telehealth Intervention
• Psychoeducational Waitlist Control
• EMI Smartphone App Pilot

Interventions

Type	Name	Description
BEHAVIORAL	RELAX	The RELAX intervention is a social-emotional intervention consisting of 8 weekly, 1.5 hr sessions and a booster session 1 month and 6 months after the completion of RELAX. During the first 60 minutes of RELAX sessions, parents and adolescents meet separately; during the last 30 minutes combined parent-adolescent discussion and problem-solving activities take place. RELAX is structured such that parents learn emotion regulation/coping skills the week prior to them being taught to the adolescents. Group sessions will involve both didactics and discussion of topics including psychoeducation, basic cognitive/behavioral principles, emotional awareness, emotion regulation strategies, parent emotion socialization practices, coping skills, conflict management strategies, and communication skills.
BEHAVIORAL	Psychoeducational Materials	Infographics with information on emotion regulation development, emotion regulation strategies, and strategies for managing interpersonal conflict, including when different strategies are more or less effective will be provided to participants via email.

Timeline

• Start date: 2025-01-15
• Primary completion: 2027-05-01
• Completion: 2028-12-01
• First posted: 2024-12-10
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States