Helping pregnant people manage ADHD symptoms during pregnancy and after birth
Supporting Expectant Mothers With ADHD Through the Transition to Parenthood: A Pilot RCT
This trial will test a behavioral program called MomMA to help pregnant people with ADHD manage their symptoms during pregnancy and after the baby is born.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07001293 on ClinicalTrials.gov |
What this trial studies
This randomized pilot trial will enroll 40 pregnant individuals with DSM-5 ADHD and randomize 20 to the MomMA behavioral intervention and 20 to treatment as usual, delivered by women's health behavioral therapists. The MomMA program teaches ADHD management skills tailored for pregnancy and the postpartum period. Investigators will measure maternal ADHD symptom severity and impairment, parent-child attachment, and infant temperament, and will explore executive function and emotion regulation as target mechanisms. The study also evaluates implementation outcomes including feasibility, acceptability, provider training and fidelity, and barriers and facilitators to integrating clinic screening and intervention into routine obstetric workflows.
Who should consider this trial
Good fit: Pregnant individuals aged 18 or older, between 14 and 22 weeks' gestation, who meet DSM-5 criteria for ADHD, speak English, and live in Pennsylvania are ideal candidates.
Not a fit: Patients with active substance use disorders requiring dual-diagnosis care, intellectual disability, bipolar disorder, psychosis, major depressive disorder with suicidal ideation, specified high-complexity pregnancy conditions, or those outside the gestational window or living outside Pennsylvania are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the program could reduce maternal ADHD symptoms and improve parent-child interactions and early child outcomes by strengthening maternal self-regulation and parenting supports.
How similar studies have performed: Behavioral therapies for adult ADHD have demonstrated benefit in nonpregnant populations, but perinatal-specific ADHD interventions are scarce, making this a relatively novel pilot of implementation in obstetric settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Heather M Joseph, DO Assistant Professor of Psychiatry and Pediatrics — University of Pittsburgh
- Study coordinator: Michelle Wilson, Research Coordinator
- Email: wilsonm13@upmc.edu
- Phone: 412-420-8309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.