Clinical trial NCT06725186: Regulating Emotions Like An eXpert Among Adolescents With ADHD
Official title: Improving Emotion Dysregulation and Interpersonal Conflict Among Families of Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: RELAX Telehealth Intervention
Psychoeducational Waitlist Control
EMI Smartphone App Pilot
Keywords: ADHD
telehealth
emotion regulation
family conflict
parenting
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study seeks to quantify the efficacy of the telehealth RELAX intervention (n = 30) relative to a psychoeducational waitlist control (PWL; n = 30) through a RCT. The psychoeducational component will consist of infographics for parents and adolescents regarding ER strategies, parent emotion socialization, and managing interpersonal conflict. Participants will be 60 adolescents with ADHD in middle or high school (ages 11-16) who display moderate to severe emotion dysregulation as measured by the Difficulties in Emotion Regulation Scale, and a primary caregiver. Adolescents will have an estimated verbal IQ ≥ 80, as indicated by the Wechsler Intelligence Scale for Children, Fifth Edition Verbal Comprehension Index, with no evidence of severe developmental delay. All participants must be proficient in English. Adolescents may have comorbid conditions, so the sample will represent real-world adolescents with ADHD.

Ten families who complete the RELAX intervention will be asked to participate in the ecological momentary intervention (EMI) pilot study which will assess the developed EMI procedure's acceptability, appropriateness, and feasibility of using smartphone apps to practice the skills learned during RELAX both during the original 8 weekly sessions and throughout the 6 month follow-up period using Likert-ratings. Additionally, they will be asked if they are interested in accessing the mobile apps for a 4-week period to continue practicing the skills learned in RELAX and to provide more in-depth feedback on the app to the research team via a 1-hour focus group.

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.

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
timeFrame: From enrollment to the 6-month follow-up period.
measure: Cognitive Emotion Regulation Questionnaire (CERQ)
timeFrame: From enrollment to the 6-month follow-up period.
measure: Observed Parent Emotion Socialization Strategies
timeFrame: From enrollment to the 6-month follow-up period.
measure: Conflict Behavior Questionnaire (CBQ)
timeFrame: From enrollment to the 6-month follow-up period.
measure: Coping with Children's Negative Emotions Scale (CCNES) - Adolescent Version -
timeFrame: From enrollment to the 6-month follow-up period.
Secondary outcomes:
measure: Center for Epidemiological Studies Depression Scale for Children (CES-DC)
timeFrame: From enrollment to the 6-month follow-up period.
measure: Screen for Child Anxiety Related Emotional Disorders (SCARED)
timeFrame: From enrollment to the 6-month follow-up period.
measure: Proactive and Reactive Aggression Measure (PRAM)
timeFrame: From enrollment to the 6-month follow-up period.
measure: Self-Injurious Thoughts and Behaviors
timeFrame: From enrollment to the 6-month follow-up period.
measure: Vanderbilt ADHD Rating Scale (VARS)
timeFrame: From enrollment to the 6-month follow-up period.
measure: Homework Performance Questionnaire (HPQ)
timeFrame: From enrollment to the 6-month follow-up period.
measure: Depression Anxiety Stress Scales - 21 item (DASS-21)
timeFrame: From enrollment to the 6-month follow-up period.
measure: Alabama Parenting Questionnaire - Short Form (APQ-9)
timeFrame: From enrollment to the 6-month follow-up period.
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Child Study Center
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Rosanna Breaux, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Breaux, R., Shroff, D. M., Cash, A. R., Swanson, C. S., Carlton, C., Bertollo, J. R., & Dahiya, A. V. (2023). Telehealth delivery of the RELAX intervention for families of adolescents diagnosed with ADHD: Preliminary treatment outcomes and evidence of acceptability and feasibility. Evidence-Based Practice in Child & Adolescent Mental Health, 8, 24-38. doi: 10.1080/23794925.2021.1970053