Expectant Moms Managing Attention-Deficit/ Hyperactivity Disorder

NCT ID: NCT07001293

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2028-05-31

Brief Summary

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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

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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

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ADHD Perinatal Behavioral Intervention

Keywords

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ADHD Pregnancy Perinatal Mental Health Behavioral Intervention Parenting Emotion Regulation Executive Functioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MomMA Intervention

Group Type EXPERIMENTAL

MomMA Intervention

Intervention Type BEHAVIORAL

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.

Treatment As Usual (TAU)

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

Group Type OTHER

Treatment as Usual (TAU)

Intervention Type OTHER

Participants will receive treatment as usual, including but not limited to medication and behavioral therapy. No participation in treatment is required.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, College Park

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Heather Joseph

Assistant Professor of Psychiatry and Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heather M Joseph, DO Assistant Professor of Psychiatry and Pediatrics

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Andrea Chronis-Tuscano, PhD Joel & Kim Feller Endowed Professor

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

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UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Michelle Wilson, Research Coordinator

Role: CONTACT

Phone: 412-420-8309

Email: [email protected]

Facility Contacts

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Melissa Glader, LCSW

Role: primary

References

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Chronis-Tuscano A, Clarke TL, O'Brien KA, Raggi VL, Diaz Y, Mintz AD, Rooney ME, Knight LA, Seymour KE, Thomas SR, Seeley J, Kosty D, Lewinsohn P. Development and preliminary evaluation of an integrated treatment targeting parenting and depressive symptoms in mothers of children with attention-deficit/hyperactivity disorder. J Consult Clin Psychol. 2013 Oct;81(5):918-25. doi: 10.1037/a0032112. Epub 2013 Mar 11.

Reference Type BACKGROUND
PMID: 23477479 (View on PubMed)

Joseph HM, Khetarpal SK, Wilson MA, Molina BSG. Parent ADHD Is Associated With Greater Parenting Distress in the First Year Postpartum. J Atten Disord. 2022 Jul;26(9):1257-1268. doi: 10.1177/10870547211066488. Epub 2021 Dec 23.

Reference Type BACKGROUND
PMID: 34937412 (View on PubMed)

Other Identifiers

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STUDY25030051

Identifier Type: -

Identifier Source: org_study_id