Expectant Moms Managing Attention-Deficit/ Hyperactivity Disorder

NCT07001293 | Not Yet Recruiting DMC

• 1 other identifier: STUDY25030051
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Intervention Acceptability

  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).

  Post Intervention (36 weeks gestational age)

• Intervention Feasibility

  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).

  Post Intervention (36 weeks gestational age)

• Intervention Appropriateness

  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).

  Post Intervention (36 weeks gestational age)

• ADHD Symptom Severity

  Number and severity of ADHD symptoms will be self-reported using the Barkley Adult ADHD Rating Scale-IV (BAARS-IV). Number and severity of ADHD symptoms will be self-reported using the Barkley Adult ADHD Rating Scale-IV (BARRS-IV). Total score (range 18-72) and number of symptoms (0-18) will be determined by summing the Inattention (total score: range 9-36; number of symptoms: range 0-9), Hyperactivity (total score: range 5-20; number of symptoms: range 0-5), and Impulsivity (total score: range 4-16; number of symptoms: range 0-4) subscales. On all scales, higher scores indicate greater ADHD symptoms.

  Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum)

• ADHD Functional Impairment

  Impairment in family functioning and self-concept will be assessed on two subscales of the Weiss Functional Impairment Rating Scale (WFIRS-S). Impairment in family functioning and self-concept will be assessed on two subscales of the Weiss Functional Impairment Rating Scale (WFIRS-S). For each scale, mean impairment (range 0-3) and a total impairment score (Family subscale: range 0-24; Self-Concept subscale: range 0-15) will be calculated. Any subscale with at least 2 items scored a 2 or 3, one item scored 3, or a mean score of \>1.5 is considered impaired.

  Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum)

• Perinatal Mood/Distress

  Symptoms of depression, anxiety, and distress will be assessed using self-report on the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder scale (GAD-7), and Perceived Stress Scale (PSS). Symptoms of depression, anxiety, and distress will be assessed using self-report on the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder scale (GAD-7), and Perceived Stress Scale (PSS). The PHQ-9 (total score range 0-27) measures depression, with higher scores indicating greater depressive symptoms. The GAD-7 (total score range 0-21) measures anxiety, with higher scores indicating greater anxiety symptoms. The PSS (total score range 0-40) measures perceived stress, with higher scores indicating greater perceived stress.

  Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum)

Secondary Outcomes (4)

• Attachment

  Postpartum follow-up (4-5 months postpartum)

• Home Environment

  Postpartum follow-up (4-5 months postpartum)

• Infant Behavior

  Postpartum follow-up (4-5 months postpartum)

• Parent-Child Interaction

  Postpartum follow-up (4-5 months postpartum)

Other Outcomes (2)

• Parent Executive Function

  Change from baseline to Post Intervention (36 weeks gestational age)

• Parent Emotion Regulation

  Change from Baseline to Post Intervention (36 weeks gestational age)

Study Arms (2)

MomMA Intervention

EXPERIMENTAL

Behavioral: MomMA Intervention

Treatment As Usual (TAU)

OTHER

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

Other: Treatment as Usual (TAU)

Interventions

Treatment as Usual (TAU) OTHER

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

Treatment As Usual (TAU)

MomMA Intervention 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.

MomMA Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meets full DSM-5 criteria for ADHD
• is between 14- and 22-weeks of gestation
• years of age or older
• English speaking
• Lives in Pennsylvania

You may not qualify if:

• substance use disorders requiring dual diagnosis treatment
• intellectual disability
• bipolar disorder, psychosis, and major depressive disorder with suicidal ideation
• the following high complexity medical conditions during pregnancy: maternal cancer, multiples, placenta accreta, and/or fetus known to have a severe congenital condition

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Maryland, College Park: collaborator

Study Sites (1)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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.

  PMID: 23477479 BACKGROUND

• 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.

  PMID: 34937412 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Emotional Regulation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Heather M Joseph, DO Assistant Professor of Psychiatry and Pediatrics

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

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

  University of Maryland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Wilson, Research Coordinator

CONTACT

412-420-8309; wilsonm13@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry and Pediatrics

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: June 3, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be shared upon publication or 1 year after the grant end date. Data will be available indefinitely.

Locations

US (1)