Regulating Emotions Like An eXpert Among Adolescents With ADHD
Recruiting · NCT06725186 · Interventional (participants receive a specific treatment) · Lead sponsor: Virginia Polytechnic Institute and State University
View the official record on ClinicalTrials.gov →Interventions studied
Psychoeducational MaterialsRELAX
What this trial is about
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 can take part
Age range
11 Years to 16 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- 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)
- participating parent/legal guardian has custody/medical decision making of the child
- family uses English as one of their primary languages (i.e., able to participate in study visits and intervention conducted in English)
Exclusion criteria
- child not diagnosed with ADHD as confirmed by prior documented diagnosis and/or current comprehensive ADHD assessment as part of intake visit
- having a child outside of the eligible age range of 11-16 at time of study enrollment
- participating parent not having legal custody of the child
- having parents or children who are not fluent in English
- having a child with a severe developmental delay either from genetic origins (e.g., Down Syndrome) or complications from pregnancy/birth (e.g., infection, micro-premature)
- child has an IQ \< 70.
Where it is running
1 location listed across 1 US state.
- Child Study Center - Blacksburg, Virginia, United States