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Clinical Trials/NCT03733548
NCT03733548
Completed
N/A

Improving Emotion Regulation in Adolescents With ADHD

Virginia Commonwealth University2 sites in 1 country20 target enrollmentOctober 30, 2018
ConditionsAdhd

Overview

Phase
N/A
Intervention
Not specified
Conditions
Adhd
Sponsor
Virginia Commonwealth University
Enrollment
20
Locations
2
Primary Endpoint
Change in Emotion Dysregulation
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of our study is to examine the impact of a program that provides emotion regulation skills for adolescents aged 11-16 with Attention-Deficit/Hyperactivity Disorder (ADHD) and poor emotion regulation. The program is called RELAX (Regulating Emotions Like An eXpert). RELAX is an experimental intervention that may equip adolescents with emotion regulation and conflict management skills and includes parent involvement to help parents support adolescents' use of these skills.

Detailed Description

Regulating Emotions Like An eXpert (RELAX) consists of 8 weekly 90-minute group sessions and 1 booster session 8 weeks after the completion of the RELAX intervention. The first 60 minutes of each group involve separate parent and adolescent groups. Adolescents (ages 11-16) attend an emotion regulation and conflict management skills group, while parents attend a group focused on how to support utilization of these skills in adolescents at home and school through use of modeling their own emotion regulation skills and use of supportive emotion socialization practices. For the final 30 minutes of the session, parents and adolescents combine and complete a collaborative activity and skill rehearsal homework is discussed for the week. Homework will be discussed at the beginning of the separate group meetings the following week. The primary overall goal of the RELAX intervention is to assist adolescents and parents in traveling down the Path of RELAXation by working on the three C's (communication, coping, and conflict management skills). A multimethod assessment of emotional, social, and family functioning will be assessed pre- and post-intervention and at an 8 week follow-up.

Registry
clinicaltrials.gov
Start Date
October 30, 2018
End Date
June 27, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Emotion Dysregulation

Time Frame: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention)

Parent and adolescent-reported emotion regulation on the Difficulties in Emotion Regulation Scale (DERS; Bunford et al., 2018; Kaufman et al., 2016). Total score is out of 180 (5 point Likert for each of 36 items). Higher scores indicate more difficulties with emotion regulation. RSA will be assessed with an EKG: three electrodes will be placed in a bipolar configuration on the left and right rib cage and the sternum. RSA is a measure of heart rate variability based on the respiratory cycle and is an indicator of vagal regulation (Berntson, Cacioppo, \& Quigley, 1997). Decreases in RSA, or RSA withdrawal, correspond to increased heart-rate and arousal; whereas, increases in RSA, or RSA augmentation, correspond to decreased arousal.

Change in Family Conflict

Time Frame: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention)

Parent and adolescent-reported family conflict as measured by the Conflict Behavior Questionnaire (CBQ). The CBQ consists of 20 true-false questions, with higher scores indicating more conflict between parents and their children.

Secondary Outcomes

  • Emotion Reactivity Predicting Treatment Outcomes(Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention))
  • Change in Emotion Socialization Predicting Treatment Outcomes(Baseline, Post-Intervention (Completion of 8 week intervention))

Study Sites (2)

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