Regulating Emotions Like An eXpert Among Adolescents With ADHD

NCT06725186 | Recruiting

• 1 other identifier: 24-1281
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

ADHD; telehealth; emotion regulation; family conflict; parenting

Outcome Measures

Primary Outcomes (5)

• Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)

  The DERS-SF will be used to assess emotion regulation problems (e.g., poor emotion awareness, poor emotion clarity, non-acceptance of emotions, poor access to emotion regulation strategies). The DERS will be completed at all timepoints by both parents and adolescents, with parents completing ratings for themselves and for their adolescents. The 18 DERS items are rated on a 5-point scale ranging from 1 - Almost Never (0-10%) to 5 - Almost Always (91-100%) and the total score represents a sum across items (with 3 items reversed score; range = 18-90) such that higher scores indicate greater dysregulation.

  From enrollment to the 6-month follow-up period.

• Cognitive Emotion Regulation Questionnaire (CERQ)

  The CERQ is a 36-item scale designed to evaluate cognitive aspects of emotion regulation or cognitive coping strategies (e.g., self-blame, rumination, putting into perspective, positive reappraisal, acceptance). Parents and adolescents are asked to rate what they generally think when they experience negative or unpleasant events on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). Each subscale consists of 4 items. Of the 4 items included in a scale a sum score is made (simple straight count), which can range from 4 (never used) to 20 (often used cognitive coping strategy). Not more than 1 of the 4 items included in a scale may be 'missing'. In that case, the 'missing' score is replaced by the average of the three remaining scores. In this manner, even in the case of a missing value, a scale score ranging from 4 to 20 is obtained, with higher scores indicating more often using that particular cognitive coping strategy.

  From enrollment to the 6-month follow-up period.

• Observed Parent Emotion Socialization Strategies

  The Conflict Discussion Task will be coded for parent emotion socialization in response to adolescents' distress through seven possible reactions: emotion-focused (i.e., empathy and validation), problem-focused (i.e., targeting the stressor itself with questions and advice), minimizing (i.e., dismissing the affect as unimportant), punitive (i.e., blaming the adolescent for the affect); magnifying (i.e., intensifying adolescents' affect), autonomy-inhibiting (i.e., interfering with adolescents' independence in dealing with their affect), and facilitative engagement (i.e., general sensitivity and responsiveness to adolescents' attempts to discuss affect). Responses are coded on a scale representing an (1) absence, (2) minimal, (3) moderate, or (4) strong presence of the behavior reflected. These codes will be collapsed into supportive (emotion-focused, problem-focused, facilitative engagement) and non-supportive (minimizing, punitive, magnifying, autonomy-inhibiting) responses.

  From enrollment to the 6-month follow-up period.

• Conflict Behavior Questionnaire (CBQ)

  The CBQ consists of 20 true-false questions regarding how well parent and adolescents get along, get angry at each other, and behaviors that occur during arguments. The CBQ total score ranges from 0-20 with higher scores indicating more parent-adolescent conflict.

  From enrollment to the 6-month follow-up period.

• Coping with Children's Negative Emotions Scale (CCNES) - Adolescent Version -

  Parent and adolescent report on the CCNES Adolescent Version will be collected to assess changes in parent emotion socialization. The CCNES-Adolescent consists of 9 hypothetical situations, each with 6 possible responses for how parents would react rated on a 7-point Likert scale ranging from 1 - Very Unlikely to 7 - Very Likely. These 6 response types each become a subscale (distress, punitive, expressive encouragement, emotion-focused, problem-focused, and minimization), with each subscale score representing the mean rating across the 9 items. These 6 subscales can be further collapsed into supportive (expressive encouragement, emotion-focused, problem-focused) and non-supportive (distress, punitive, minimization) responses, with higher scores indicating a greater likelihood a parent will use that particular response type.

  From enrollment to the 6-month follow-up period.

Secondary Outcomes (8)

• Center for Epidemiological Studies Depression Scale for Children (CES-DC)

  From enrollment to the 6-month follow-up period.

• Screen for Child Anxiety Related Emotional Disorders (SCARED)

  From enrollment to the 6-month follow-up period.

• Proactive and Reactive Aggression Measure (PRAM)

  From enrollment to the 6-month follow-up period.

• Self-Injurious Thoughts and Behaviors

  From enrollment to the 6-month follow-up period.

• Vanderbilt ADHD Rating Scale (VARS)

  From enrollment to the 6-month follow-up period.

Study Arms (2)

RELAX Intervention

EXPERIMENTAL

group-based RELAX telehealth intervention

Behavioral: RELAX

Psychoeducational Waitlist Control

ACTIVE COMPARATOR

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

Behavioral: Psychoeducational Materials

Interventions

RELAX 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.

RELAX Intervention

Psychoeducational Materials 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.

Psychoeducational Waitlist Control

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Child Study Center

Blacksburg, Virginia, 24060, United States

RECRUITING

Related Publications (1)

• 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

  BACKGROUND

Related Links

• CALMER Lab Website Description of the RELAX Intervention

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Emotional Regulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Rosanna Breaux, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosanna Breaux, PhD

CONTACT

5402318276; calmerlab@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)