Helping adolescents with ADHD regulate their emotions through telehealth
Improving Emotion Dysregulation and Interpersonal Conflict Among Families of Adolescents With ADHD
This study is testing a telehealth program called RELAX to see if it can help teenagers with ADHD learn to manage their emotions better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 11 Years to 16 Years |
| Sex | All |
| Sponsor | Virginia Polytechnic Institute and State University Academic / other |
| Locations | 1 site (Blacksburg, Virginia) |
| Trial ID | NCT06725186 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the RELAX intervention, a telehealth program designed to help adolescents with ADHD improve their emotion regulation skills. In a randomized controlled format, 30 families will receive the RELAX intervention while another 30 will receive psychoeducational materials as a control. The study also includes a pilot component where 10 families from the RELAX group will provide feedback on smartphone apps developed to support the skills learned during the intervention. Participants will be adolescents aged 11-16 with ADHD who experience moderate to severe emotion dysregulation.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 11-16 diagnosed with ADHD who exhibit moderate to severe emotion dysregulation.
Not a fit: Patients outside the age range of 11-16 or those not diagnosed with ADHD will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve emotion regulation in adolescents with ADHD, leading to better family dynamics and personal outcomes.
How similar studies have performed: While similar telehealth interventions have shown promise, this specific approach is novel in its focus on emotion regulation for adolescents with ADHD.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Blacksburg, Virginia
- Child Study Center — Blacksburg, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Rosanna Breaux, PhD — Virginia Polytechnic Institute and State University
- Study coordinator: Rosanna Breaux, PhD
- Email: calmerlab@gmail.com
- Phone: 5402318276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.