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Behavioral Intervention
Emotional Regulation Intervention for Adolescents (RELAX Trial)
Blacksburg, VA
N/A
Recruiting
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 has no evidence of severe developmental delay either from genetic origins (e.g., Down Syndrome) or complications during pregnancy/birth (e.g., infection, micropremature)
Be younger than 18 years old
Must not have
Having a child outside of the eligible age range of 11-16 at time of study enrollment
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 trial will test a program called RELAX to see if it helps families manage their emotions better. 30 families will try the RELAX program while another 30 will receive educational materials. Some families
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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.Check my eligibility
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.See study design
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 belowSelect...
My child does not have severe developmental delays from genetic conditions or birth complications.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My child is not between 11 and 16 years old.
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Timeline
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)
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
Depression Anxiety Stress Scales - 21 item (DASS-21)
+5 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
Closest Location:Child Study Center· Blacksburg, VA· 236 miles
Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
160 Previous Clinical Trials
26,807 Total Patients Enrolled
2 Trials studying Telemedicine
248 Patients Enrolled for Telemedicine
Rosanna Breaux, PhDPrincipal InvestigatorVirginia Polytechnic Institute and State University