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Behavioral Intervention
Regulating Emotions Like an EXpert Among Adolescents with ADHD (RELAX Trial)
N/A
Waitlist Available
Led By Rosanna Breaux, PhD
Research Sponsored by Virginia Polytechnic Institute and State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to the 6-month follow-up period.
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for adolescents with ADHD who might also be struggling with mobile phone addiction. It's open to families willing to try a new intervention called RELAX or receive psychoeducational materials. The study will exclude certain individuals based on criteria not specified here.
What is being tested?
The trial is testing the RELAX intervention against standard psychoeducational materials to see which helps more with emotion regulation in teens with ADHD. Half of the participants will get RELAX, and half will get educational materials, decided randomly.
What are the potential side effects?
Since this study involves psychological interventions rather than medications, traditional side effects are not expected. However, participants may experience discomfort or emotional distress when discussing personal issues during therapy sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to the 6-month follow-up period.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to the 6-month follow-up period.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cognitive Emotion Regulation Questionnaire (CERQ)
Conflict Behavior Questionnaire (CBQ)
Coping with Children's Negative Emotions Scale (CCNES) - Adolescent Version -
+2 moreSecondary study objectives
Alabama Parenting Questionnaire - Short Form (APQ-9)
Barkley Adult ADHD Rating Scale-IV (BAARS)
Center for Epidemiological Studies Depression Scale for Children (CES-DC)n
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RELAX InterventionExperimental Treatment1 Intervention
group-based RELAX telehealth intervention
Group II: Psychoeducational Waitlist ControlActive Control1 Intervention
The psychoeducational component will consist of infographics regarding emotion regulation strategies and managing interpersonal conflict.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RELAX
2018
N/A
~20
Find a Location
Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
156 Previous Clinical Trials
25,680 Total Patients Enrolled
Rosanna Breaux, PhDPrincipal InvestigatorVirginia Polytechnic Institute and State University