Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-01-03 @ 10:59 PM
Study NCT ID:
NCT07001293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expectant Moms Managing Attention-Deficit/ Hyperactivity Disorder
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Supporting Expectant Mothers With ADHD Through the Transition to Parenthood: A Pilot RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
MomMA
Brief Summary:
The goal of this study is to test a behavioral program for pregnant individuals with ADHD. This behavioral program focuses on skills for managing ADHD and related symptoms in pregnancy and postpartum.
This pilot effectiveness-implementation trial aims to (1) preliminarily evaluate the MomMA behavioral intervention compared to treatment as usual (TAU) on clinical outcomes and (2) evaluate implementation outcomes, including feasibility and acceptability of clinic screening within existing OB workflows; assessment and intervention protocols; provider training/fidelity to manual; and all other study protocols from the perspective of real-world providers and participants.
This pilot effectiveness-implementation trial aims to (1) preliminarily evaluate the MomMA behavioral intervention compared to treatment as usual (TAU) on clinical outcomes and (2) evaluate implementation outcomes, including feasibility and acceptability of clinic screening within existing OB workflows; assessment and intervention protocols; provider training/fidelity to manual; and all other study protocols from the perspective of real-world providers and participants.
Detailed Description:
Treating pregnant individuals with ADHD may improve parent and child wellbeing, parent-child interactions, and psychosocial familial factors to enhance family resilience and reduce prevalence/severity of child mental health disorders. The current study will test the MomMA (Moms Managing ADHD) intervention and implement it via a randomized controlled trial (N= 60 pregnant women with ADHD; 30 receiving the behavioral intervention and 30 receiving TAU), delivered by women's health behavioral therapists. Investigators will examine treatment acceptability, feasibility, and appropriateness, as well as implementation factors (fidelity, adherence, facilitators/barriers). In addition, quantitative data will be used to assess parent and child clinical outcomes, including maternal ADHD symptom severity and impairment (primary), parent-child attachment, and infant temperament/behavior. Finally, changes in target mechanisms (executive function and emotion regulation) and whether changes in the target are associated with change in clinical outcomes will be explored.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|---|
| R34MH139774 | OTHER_GRANT | National Institute of Mental Health | View |