NCT07001293

Expectant Moms Managing Attention-Deficit/ Hyperactivity Disorder

Supporting Expectant Mothers With ADHD Through the Transition to Parenthood: A Pilot RCT

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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= 40 pregnant women with ADHD; 20 receiving the behavioral intervention and 20 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.

Conditions

• ADHD
• Perinatal
• Behavioral Intervention

Interventions

Type	Name	Description
BEHAVIORAL	MomMA Intervention	The MomMA program is a CBT-based behavioral intervention with components targeted specifically towards expectant parents with ADHD. Treatment will be delivered by therapists embedded in OB care settings.
OTHER	Treatment as Usual (TAU)	Participants will receive treatment as usual, including but not limited to medication and behavioral therapy. No participation in treatment is required.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2025-06-03
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States