Recruiting

MomMA

Sponsor:

University of Pittsburgh

Code:

NCT07001293

Conditions

ADHD

Perinatal

Behavioral Intervention

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MomMA Intervention

Treatment as Usual (TAU)

Study Details

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.

Conditions

ADHD

Perinatal

Behavioral Intervention

Study ID

NCT07001293

Start date

Apr 26, 2026

Status verified date

Mar, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MomMA Intervention

other: Treatment As Usual (TAU)

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

Interventions

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.

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.

Primary outcome measure

  • Intervention Acceptability [ Time Frame: Post Intervention (36 weeks gestational age) ]
  • Intervention Feasibility [ Time Frame: Post Intervention (36 weeks gestational age) ]
  • Intervention Appropriateness [ Time Frame: Post Intervention (36 weeks gestational age) ]
  • ADHD Symptom Severity [ Time Frame: Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum) ]
  • ADHD Functional Impairment [ Time Frame: Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum) ]
  • Perinatal Mood/Distress [ Time Frame: Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum) ]

Central Contacts and Locations

Central contacts

Michelle Wilson, Research Coordinator

412-420-8309wilsonm13@upmc.edu

Locations

UPMC Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Melissa Glader, LCSW

412-641-1238gladerm@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

May 7, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-05-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.