Recruiting

Emotional Regulation

Sponsor:

Virginia Polytechnic Institute and State University

Code:

NCT06725186

Conditions

RELAX Telehealth Intervention

Psychoeducational Waitlist Control

EMI Smartphone App Pilot

Eligibility Criteria

Sex: All

Age: 11 - 16

Healthy Volunteers: Not accepted

Interventions

RELAX

Psychoeducational Materials

Study Details

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.

Conditions

RELAX Telehealth Intervention

Psychoeducational Waitlist Control

EMI Smartphone App Pilot

Study ID

NCT06725186

Start date

Jan 15, 2025

Status verified date

Jan, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 16

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RELAX Intervention

group-based RELAX telehealth intervention

active comparator: Psychoeducational Waitlist Control

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

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.

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.

Primary outcome measure

  • Difficulties in Emotion Regulation Scale - Short Form (DERS-SF) [ Time Frame: From enrollment to the 6-month follow-up period. ]
  • Cognitive Emotion Regulation Questionnaire (CERQ) [ Time Frame: From enrollment to the 6-month follow-up period. ]
  • Observed Parent Emotion Socialization Strategies [ Time Frame: From enrollment to the 6-month follow-up period. ]
  • Conflict Behavior Questionnaire (CBQ) [ Time Frame: From enrollment to the 6-month follow-up period. ]
  • Coping with Children's Negative Emotions Scale (CCNES) - Adolescent Version - [ Time Frame: From enrollment to the 6-month follow-up period. ]

Central Contacts and Locations

Central contacts

Rosanna Breaux, PhD

5402318276calmerlab@gmail.com

Locations

Child Study Center

Recruiting

Blacksburg, Virginia, United States, 24060

Contacts

Rosanna Breaux, PhD

540-231-8276calmerlab@gmail.com

More Information

Sponsor

Virginia Polytechnic Institute and State University

Last update posted

Mar 30, 2026

Last verified

Jan, 2026

Keywords

  • ADHD
  • telehealth
  • emotion regulation
  • family conflict
  • parenting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Polytechnic Institute and State University on 2026-03-30.