Expectant Moms Managing Attention-Deficit/ Hyperactivity Disorder (MomMA)

University of Pittsburgh

Status: Not yet enrolling

Conditions: Perinatal; ADHD; Behavioral Intervention

Treatments: Behavioral: MomMA Intervention; Other: Treatment as Usual (TAU)

Study type: Interventional

Funder types: Other

Identifiers

NCT07001293

STUDY25030051

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. meets full DSM-5 criteria for ADHD
2. is between 14- and 22-weeks of gestation
3. 18 years of age or older
4. English speaking
5. Lives in Pennsylvania

Exclusion criteria

1. substance use disorders requiring dual diagnosis treatment
2. intellectual disability
3. bipolar disorder, psychosis, and major depressive disorder with suicidal ideation
4. the following high complexity medical conditions during pregnancy: maternal cancer, multiples, placenta accreta, and/or fetus known to have a severe congenital condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

MomMA Intervention

Experimental group

Treatment:

Behavioral: MomMA Intervention

Treatment As Usual (TAU)

Other group

Description:

Treatment will be determined by participant and their medical and behavioral health providers.

Treatment:

Other: Treatment as Usual (TAU)