Regulating Emotions Like An eXpert Among Adolescents With ADHD

NCT ID: NCT06725186

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2028-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RELAX Intervention

group-based RELAX telehealth intervention

Group Type: EXPERIMENTAL

RELAX

Intervention Type: BEHAVIORAL

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.

Psychoeducational Waitlist Control

The psychoeducational component will consist of infographics regarding emotion regulation strategies and managing interpersonal conflict.

Group Type: ACTIVE_COMPARATOR

Psychoeducational Materials

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• child with ADHD in middle or high school at time of study entry
• child has an estimated verbal IQ >=80 based on the Wechsler Intelligence Scale for Children, Fifth Edition Verbal Comprehension Index
• child has no evidence of severe developmental delay either from genetic origins (e.g., Down Syndrome) or complications during pregnancy/birth (e.g., infection, micropremature)
• participating parent/legal guardian has custody/medical decision making of the child
• family uses English as one of their primary languages (i.e., able to participate in study visits and intervention conducted in English)

Exclusion Criteria

• child not diagnosed with ADHD as confirmed by prior documented diagnosis and/or current comprehensive ADHD assessment as part of intake visit
• having a child outside of the eligible age range of 11-16 at time of study enrollment
• participating parent not having legal custody of the child
• having parents or children who are not fluent in English
• having a child with a severe developmental delay either from genetic origins (e.g., Down Syndrome) or complications from pregnancy/birth (e.g., infection, micro-premature)
• child has an IQ < 70.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosanna Breaux, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

Child Study Center

Blacksburg, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rosanna Breaux, PhD

Role: CONTACT

calmerlab@gmail.com

5402318276

Facility Contacts

Rosanna Breaux, PhD

Role: primary

calmerlab@gmail.com

540-231-8276

References

Breaux, R., Shroff, D. M., Cash, A. R., Swanson, C. S., Carlton, C., Bertollo, J. R., & Dahiya, A. V. (2023). Telehealth delivery of the RELAX intervention for families of adolescents diagnosed with ADHD: Preliminary treatment outcomes and evidence of acceptability and feasibility. Evidence-Based Practice in Child & Adolescent Mental Health, 8, 24-38. doi: 10.1080/23794925.2021.1970053

Reference Type: BACKGROUND

Related Links

https://www.calmerlab.com/the-relax-intervention

CALMER Lab Website Description of the RELAX Intervention

Other Identifiers

24-1281

Identifier Type: -

Identifier Source: org_study_id