Impact of Parental Emotion Regulation on the Treatment of ADHD

NCT05299814 | Recruiting

• 1 other identifier: PERS
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To examine if parental emotion regulation (ER) moderates the response to parent training interventions. H1: Reduced parental ER capacity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD. H2: Increased parental emotional reactivity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD.

Conditions

ADHD

Keywords

oppositional behaviors, conduct problems

Outcome Measures

Primary Outcomes (1)

• Change in Oppositional Defiant Disorder Symptoms (change from baseline to endpoint)

  This will be measured using parent ratings of symptoms of Oppositional Defiant Disorder as rated on the Disruptive Behavior Disorder Rating Scale (DBD-RS). The Oppositional Behavior subscale on the DBD-RS measures 8 items rated 0-3. Items are averaged to create a mean total score between 0-3. Higher scores indicate greater impairment and worse outcomes.

  baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))

Secondary Outcomes (9)

• Change in ADHD symptoms (change from baseline to endpoint)

  baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))

• Change in Conduct Disorder Symptoms (change from baseline to endpoint)

  baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))

• Change in Irritability symptoms (change from baseline to endpoint)

  baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))

• Change in rates of Poor Monitoring from Baseline (before therapy) to Endpoint (after last therapy session)

  baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))

• Change from Baseline (before therapy) Inconsistent Discipline at Endpoint (after last therapy session)

  baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))

Study Arms (1)

Behavior Therapy

EXPERIMENTAL

8 sessions of an evidence based parenting program to address oppositional behaviors and ADHD symptoms at home. All participants are in this arm.

Behavioral: Behavioral Parenting Intervention

Interventions

Behavioral Parenting Intervention BEHAVIORAL

8 session evidence based parenting intervention

Behavior Therapy

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent of a child ages 5-12 with ADHD
• Parent must report that the child has at least a mild level of symptoms at home of Oppositional Defiant Disorder (ODD) on the Disruptive Behavior Disorder Rating Scale (DBDRS)

You may not qualify if:

• Not being the parent of a child ages 5-12 who meets diagnostic criteria for ADHD.
• Non English Speaking
• the child with ADHD has a diagnosis of intellectual delay or has prominent autistic traits
• Another child in the same family participating in this study already
• Parent does not have a smartphone or tablet device to complete EMA ratings or does not reside with child for the majority of the time.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Health Dept of Psychiatry

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

James G Waxmonsky, MD

CONTACT

7175318646; jwaxmonsky@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: single group open label design

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 29, 2022
• Study Start: April 13, 2017
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 7, 2026

Record last verified: 2025-11

Locations

US (1)