NCT06725186 Regulating Emotions Like An eXpert Among Adolescents With ADHD
| NCT ID | NCT06725186 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Virginia Polytechnic Institute and State University |
| Condition | RELAX Telehealth Intervention |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-01-15 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Rosanna Breaux, PhD
PRINCIPAL INVESTIGATOR
Virginia Polytechnic Institute and State University
Frequently Asked Questions
Who can join the NCT06725186 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 16 Years, studying RELAX Telehealth Intervention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06725186 currently recruiting?
Yes, NCT06725186 is actively recruiting participants. Contact the research team at calmerlab@gmail.com for enrollment information.
Where is the NCT06725186 trial being conducted?
This trial is being conducted at Blacksburg, United States.
Who is sponsoring the NCT06725186 clinical trial?
NCT06725186 is sponsored by Virginia Polytechnic Institute and State University. The principal investigator is Rosanna Breaux, PhD at Virginia Polytechnic Institute and State University. The trial plans to enroll 60 participants.