Improving Emotion Regulation in Adolescents With ADHD

• ClinicalTrials.gov Identifier: NCT03733548
• Recruitment Status: Completed
• First Posted: November 7, 2018
• Last Update Posted: August 12, 2019
• Sponsor: Virginia Commonwealth University
• Information provided by (Responsible Party): Virginia Commonwealth University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Adhd	Behavioral: RELAX	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Pilot trial to finish developing and refining the intervention
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Improving Emotion Regulation in Adolescents With ADHD
• Actual Study Start Date: October 30, 2018
• Actual Primary Completion Date: June 11, 2019
• Actual Study Completion Date: June 27, 2019

Arms and Interventions

Arm

Intervention/treatment

Experimental: Regulating Emotions Like An eXpert (RELAX); Families at the Virginia Commonwealth University Center for Psychological Services and Development or Clark-Hill Institute for Positive Youth Development

Behavioral: RELAX; Regulating Emotions Like An eXpert (RELAX) consists of 8 weekly, 90-minute sessions delivered (60 minutes of parents and adolescents meeting separately, 30 minutes of a combined meeting) in a group format. RELAX equips adolescents with emotion regulation and conflict management skills. This program includes a parent involvement component designed to help parents support adolescents' use of these skills. Each week skills will be discussed and practiced in group, and a skills rehearsal homework activity will be assigned. Following the program, an 8-week follow-up review session will be offered. Additionally, a single 60 minute focus group will be held following the review session to solicit parent and adolescent feedback on the intervention.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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 Outcome Measures :

1. Emotion Reactivity Predicting Treatment Outcomes [ Time Frame: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention) ]
   Baseline respiratory sinus arrhythmia (RSA) and RSA-Reactivity Predicting Change in Emotion Regulation and Family Conflict.
2. Change in Emotion Socialization Predicting Treatment Outcomes [ Time Frame: Baseline, Post-Intervention (Completion of 8 week intervention) ]
   Observed emotion socialization predicting Emotion Regulation and Family Conflict. Observational emotion socialization will be coded during a parent-adolescent conflict discussion task. During this task adolescents will be instructed to share a recent parent-adolescent conflict that was a stressor for them, and the dyad will discuss the recent conflict for five minutes. The discussions will be coded for parent responses to adolescents' distress through seven possible reactions: emotion-focused, problem-focused, minimizing, punitive; magnifying, autonomy-inhibiting, and facilitative engagement. Responses will be coded on a 4-point scale representing an (1) absence, (2) minimal, (3) moderate, or (4) strong presence of the behavior reflected in each of the codes.

Eligibility Criteria

• Ages Eligible for Study: 11 Years to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria (adolescents):

• ADHD diagnosis
• parent-reported emotion regulation in the clinical range
• full scale intelligence quotient ≥80
• English as a primary language

Contacts and Locations

Locations

United States, Virginia

Clark-Hill Institute for Positive Youth Development

Richmond, Virginia, United States, 23284

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

• Principal Investigator: Joshua Langberg, PhD; Virginia Commonwealth University

More Information

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT03733548
• Other Study ID Numbers: HM20013904
• First Posted: November 7, 2018
• Last Update Posted: August 12, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No IPD will be shared.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No