Clinical trial NCT03733548: Improving Emotion Regulation in Adolescents With ADHD
Official title: Improving Emotion Regulation in Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhd
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 20
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot trial to finish developing and refining the intervention
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria (adolescents):

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

Primary outcomes:
measure: Change in Emotion Dysregulation
timeFrame: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention)
measure: Change in Family Conflict
timeFrame: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention)
Secondary outcomes:
measure: Emotion Reactivity Predicting Treatment Outcomes
timeFrame: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention)
measure: Change in Emotion Socialization Predicting Treatment Outcomes
timeFrame: Baseline, Post-Intervention (Completion of 8 week intervention)
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Clark-Hill Institute for Positive Youth Development
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Joshua Langberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: