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NCT Number: NCT06540547

Moms Managing Attention-Deficit/Hyperactivity Disorder (ADHD) Study

The study will develop and test a behavioral program for pregnant individuals with Attention-Deficit/Hyperactivity Disorder (ADHD). This behavioral program will include skills for managing ADHD and related symptoms during pregnancy and after delivery and will be taught by a behavioral therapist in OB care settings.

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

About this study

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. Using the information provided from stakeholder interviews and adaptations of an existing CBT intervention for parents of children with ADHD, the current study will develop the MomMA (Moms Managing ADHD) intervention and implement it via an open clinical trial (n=10 pregnant individuals), delivered by masters-level women's health behavioral therapists. Investigators will examine treatment acceptability, feasibility, and appropriateness, as well as implementation factors (fidelity, adherence, facilitators/barriers) and qualitative data (e.g., feedback interviews). In addition, quantitative data (self-reported symptoms, parenting, and home environment measures; observed parent and child behavior; parent reported child temperament/behavior) will be used to assess parent and child outcomes following the intervention. This mixed-methods model will offer a comprehensive examination of the MomMA intervention and inform a refined intervention model.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) meet full DSM-5 criteria for ADHD
  • (2) are between 20- and 32-weeks of gestation
  • (3) speak English
  • (4) will deliver at the University of Pittsburgh Medical Center (UPMC) Magee Women's Hospital (MWH)

Exclusion criteria

  • (1) active substance use disorder
  • (2) intellectual disability
  • (3) other severe mental illness, including bipolar disorder, psychosis, and major depressive disorder with suicidal ideation or requiring higher level of care (inpatient or partial/intensive outpatient)
  • (4) high risk pregnancies requiring transfer of care to Maternal-Fetal Medicine (e.g., maternal cancer, multiples, placenta accreta) and/or fetus known to have a severe congenital condition.

Treatment and study plan

MomMA Intervention

Behavioral

Parents will receive sessions of CBT-based behavioral intervention with components targeted specifically towards expectant parents with ADHD. Treatment will be delivered by therapists embedded in OB care settings. The number and specific content of sessions will be determined based on community partner feedback.

Primary outcomes

  1. Intervention Acceptability

    Time frame: Post Intervention at 4-month postpartum

    Therapist and participant report of intervention acceptability will be assessed using the 4-item Acceptability of Intervention Measure (AIM), rated from rated from 1 (completely disagree) to 5 (completely agree), with scores greater than or equal to 16 indicating good acceptability.

  2. Intervention Appropriateness

    Time frame: Post Intervention at 4-month postpartum

    Therapist and participant report of intervention appropriateness will be assessed using the 4-item Intervention Appropriateness Measure (IAM), rated from 1 (completely disagree) to 5 (completely agree), with scores greater than or equal to 16 indicating good appropriateness.

  3. Intervention Feasibility

    Time frame: Post Intervention at 4-month postpartum

    Therapist and participant report of intervention feasibility will be assessed using the 4-item Feasibility of Intervention Measure (FIM), rated from 1 (completely disagree) to 5 (completely agree), with scores greater than or equal to 16 indicating good feasibility.

Study contacts

Contact information is provided by the study sponsor or research team.

Heather M Joseph, DO

CONTACT

[email protected]

4122465339

Michelle Wilson

CONTACT

[email protected]

412-420-8309

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • YourMomCares Foundation

Registry information

Official study title

Supporting Expectant Mothers With ADHD Through the Transition to Parenthood

Acronym: MomMA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2024
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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