NCT06540547

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2025Jul 2026

First Submitted

Initial submission to the registry

August 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

January 19, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

August 2, 2024

Last Update Submit

January 6, 2026

Conditions

ADHDParenting

Outcome Measures

Primary Outcomes (3)

  • 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), with scores greater than or equal to 16 indicating good acceptability.

    Post Intervention at 4-month postpartum

  • 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), with scores greater than or equal to 16 indicating good appropriateness.

    Post Intervention at 4-month postpartum

  • 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), with scores greater than or equal to 16 indicating good feasibility.

    Post Intervention at 4-month postpartum

Study Arms (1)

MomMA Intervention

EXPERIMENTAL
Behavioral: MomMA Intervention

Interventions

MomMA InterventionBEHAVIORAL

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.

MomMA Intervention

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (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)

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (2)

  • 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: 34937412BACKGROUND

  • 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: 23477479BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Heather M Joseph, DO

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather M Joseph, DO

CONTACT

4122465339liebherrh@upmc.edu

Michelle Wilson

CONTACT

412-420-8309wilsonm13@upmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 6, 2024

Study Start

January 19, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)