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

NCT04240756 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-12-16

No results posted yet for this study

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.

Conditions

  • ADHD
  • Parenting

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.

Sponsors & Collaborators

  • Children's National Research Institute

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • Seattle Children's Hospital

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Maryland, College Park

    lead OTHER

Principal Investigators

  • Andrea Chronis-Tuscano, Ph.D. · University of Maryland, College Park

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-06
Primary Completion
2025-05-30
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04240756 on ClinicalTrials.gov