Recruiting

Observational Study

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT05299814

Conditions

ADHD

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Interventions

Behavioral Parenting Intervention

Study Details

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

Study ID

NCT05299814

Start date

Apr 13, 2017

Status verified date

Nov, 2025

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

1. Not being the parent of a child ages 5-12 who meets diagnostic criteria for ADHD.
2. Non English Speaking
3. the child with ADHD has a diagnosis of intellectual delay or has prominent autistic traits
4. Another child in the same family participating in this study already
5. 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.

Study Design

Enrollment

65 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Behavior Therapy

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

Interventions

Behavioral Parenting Intervention

8 session evidence based parenting intervention

Primary outcome measure

  • Change in Oppositional Defiant Disorder Symptoms (change from baseline to endpoint) [ Time Frame: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later )) ]

Central Contacts and Locations

Central contacts

James G Waxmonsky, MD

7175318646jwaxmonsky@pennstatehealth.psu.edu

Locations

Penn State Health Dept of Psychiatry

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

James Waxmonsky

7175318646jwaxmonsky@pennstatehealth.psu.edu

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

May 7, 2026

Last verified

Nov, 2025

Keywords

  • oppositional behaviors, conduct problems

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-05-07.