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ACTIVE NOT RECRUITING
NCT04240756
PHASE3

Treating Parents with ADHD and Their Young Children Via Telehealth: a Hybrid Type I Effectiveness-Implementation Trial

Sponsor: University of Maryland, College Park

View on ClinicalTrials.gov

Summary

This study will compare the effectiveness of combined parental stimulant medication and behavioral parent training (BPT) versus BPT alone on child ADHD-related impairment (primary outcome), child ADHD and externalizing symptoms, time to child stimulant prescription (secondary child outcomes) and parental ADHD impairment, parental ADHD symptoms, parenting, and BPT engagement (parental outcomes/target mechanisms). This study will also assess the care delivery context and develop an implementation approach for treatment of families with a parent with ADHD and a child with elevated ADHD symptoms via telehealth in primary care sites providing pediatric care.

Official title: 2/2 Treating Mothers with ADHD and Their Young Children Via Telehealth: a Hybrid Type I Effectiveness-Implementation Trial

Key Details

Gender

All

Age Range

3 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2020-08-06

Completion Date

2025-07-31

Last Updated

2024-12-16

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Behavioral Parent Training

Parents will receive 10 sessions of behavioral parent training with components specifically targeted toward parents with ADHD. Treatment will be delivered via telehealth.

DRUG

Extended release mixed amphetamine salts (MAS)

The MAS protocol will include a 2-4 -week open-label titration beginning at 20 mg and dose level will be increased weekly at telehealth visits with the psychopharmacologist until an optimal response or maximum dose of 60 mg.

Locations (1)

University of Maryland

College Park, Maryland, United States