Improving Emotion Regulation in Adolescents With ADHD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03733548|
Recruitment Status : Completed
First Posted : November 7, 2018
Last Update Posted : August 12, 2019
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Adhd||Behavioral: RELAX||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Pilot trial to finish developing and refining the intervention|
|Masking:||None (Open Label)|
|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|
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
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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||11 Years to 16 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Inclusion Criteria (adolescents):
- ADHD diagnosis
- parent-reported emotion regulation in the clinical range
- full scale intelligence quotient ≥80
- English as a primary language
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733548
|United States, Virginia|
|Clark-Hill Institute for Positive Youth Development|
|Richmond, Virginia, United States, 23284|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Joshua Langberg, PhD||Virginia Commonwealth University|
|Responsible Party:||Virginia Commonwealth University|
|Other Study ID Numbers:||
|First Posted:||November 7, 2018 Key Record Dates|
|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|