Clinical trial NCT07001293: Expectant Moms Managing Attention-Deficit/ Hyperactivity Disorder
Official title: Supporting Expectant Mothers With ADHD Through the Transition to Parenthood: A Pilot RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ADHD
Perinatal
Behavioral Intervention
Keywords: ADHD
Pregnancy
Perinatal Mental Health
Behavioral Intervention
Parenting
Emotion Regulation
Executive Functioning
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Maryland, College Park
name: National Institute of Mental Health (NIMH)
First posted: 2025-06-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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= 60 pregnant women with ADHD; 30 receiving the behavioral intervention and 30 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.

Eligibility 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

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

Primary outcomes:
measure: Intervention Acceptability
timeFrame: Post Intervention (15 weeks after baseline clinical assessment)
measure: Intervention Feasibility
timeFrame: Post Intervention (15 weeks after baseline clinical assessment)
measure: Intervention Appropriateness
timeFrame: Post Intervention (15 weeks after baseline clinical assessment)
measure: ADHD Symptom Severity
timeFrame: Post Intervention (15 weeks after baseline clinical assessment) and Postpartum follow-up (4-5 months postpartum)
measure: ADHD Functional Impairment
timeFrame: Post Intervention (15 weeks after baseline clinical assessment) and Postpartum follow-up (4-5 months postpartum)
measure: Perinatal Mood/Distress
timeFrame: Post Intervention (15 weeks after baseline clinical assessment) and Postpartum follow-up (4-5 months postpartum)
Secondary outcomes:
measure: Attachment
timeFrame: Postpartum follow-up (4-5 months postpartum)
measure: Home Environment
timeFrame: Postpartum follow-up (4-5 months postpartum)
measure: Infant Behavior
timeFrame: Postpartum follow-up (4-5 months postpartum)
measure: Parent-Child Interaction
timeFrame: Postpartum follow-up (4-5 months postpartum)
Other outcomes:
measure: Parent Executive Function
timeFrame: Change from baseline to Post Intervention (15 weeks after baseline clinical assessment)
measure: Parent Emotion Regulation
timeFrame: Change from Baseline to Post Intervention (15 weeks after baseline clinical assessment)
Locations:
city: Pittsburgh
country: United States
facility: UPMC Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Heather M Joseph, DO Assistant Professor of Psychiatry and Pediatrics
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Andrea Chronis-Tuscano, PhD Joel & Kim Feller Endowed Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.