Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-30 @ 7:26 PM
Study NCT ID:
NCT04240756
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-16
First Post:
2020-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Parents with ADHD and Their Young Children Via Telehealth: a Hybrid Type I Effectiveness-Implementation Trial
Sponsor:
University of Maryland, College Park
Organization:
Study Overview
Official Title:
2/2 Treating Mothers with ADHD and Their Young Children Via Telehealth: a Hybrid Type I Effectiveness-Implementation Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TPAC
Brief 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.
Detailed Description:
Parental ADHD, present in 25-50% of families of children with ADHD and frequently untreated, interferes with effective parenting and predicts poor child developmental and behavioral treatment outcomes. Based on the literature and our own pilot data, the study will randomly assign parents with ADHD and their young at-risk children to one of two conditions: (1) stimulant medication for parents with ADHD followed by a child treatment strategy (CTS) beginning with behavioral parent training (BPT) with the added recommendation of child stimulant treatment if the child remains impaired or (2) a CTS without treatment for parental ADHD. The study will compare treatment effects on child ADHD-related impairment (primary outcome), child ADHD and externalizing symptoms, and time to child stimulant prescription (secondary child outcomes). The study will also examine target mechanisms including improvements in parental ADHD-related impairment and symptomatology (attention, impulsivity, emotional regulation), parenting skills, and BPT engagement, as well as treatment moderators (baseline parental ADHD severity, parental impairment, and parenting skills). Moreover, in an effort to develop a model of treatment that has potential for widespread dissemination while also reducing barriers to receiving care, the study will examine an implementation model involving parent ADHD screening in primary care followed by collaborative care delivered by co-located mental health providers via telehealth. Further, the investigators will develop an implementation plan and associated toolkit using a stakeholder participatory strategy to enhance the ability to move efficiently to adoption of this approach. In addition, the investigators will study the care delivery context, assessing procedures for and rates of screening and participation as well as staffing, workflow, provider- and patient-level acceptability, readiness, and feasibility of implementation approaches. This hybrid effectiveness-implementation project will be achieved via a collaborative R01 across 2 research sites in the US (N = 240 families), with 4-5 primary care partners at each site.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01MH118313 | NIH | None | https://reporter.nih.gov/quic… | View |