Clinical trial NCT06540547: Moms Managing Attention-Deficit/Hyperactivity Disorder (ADHD) Study
Official title: Supporting Expectant Mothers with ADHD Through the Transition to Parenthood
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Parenting
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: YourMomCares Foundation
First posted: 2024-08-06
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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. Using the information provided from stakeholder interviews and adaptations of an existing CBT intervention for parents of children with ADHD, the current study will develop the MomMA (Moms Managing ADHD) intervention and implement it via an open clinical trial (n=10 pregnant individuals), delivered by masters-level women's health behavioral therapists. Investigators will examine treatment acceptability, feasibility, and appropriateness, as well as implementation factors (fidelity, adherence, facilitators/barriers) and qualitative data (e.g., feedback interviews). In addition, quantitative data (self-reported symptoms, parenting, and home environment measures; observed parent and child behavior; parent reported child temperament/behavior) will be used to assess parent and child outcomes following the intervention. This mixed-methods model will offer a comprehensive examination of the MomMA intervention and inform a refined intervention model.

Eligibility criteria: Inclusion Criteria:

* (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)

Exclusion Criteria:

* (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.

Primary outcomes:
measure: Intervention Acceptability
timeFrame: Post Intervention at 4-month postpartum
measure: Intervention Appropriateness
timeFrame: Post Intervention at 4-month postpartum
measure: Intervention Feasibility
timeFrame: Post Intervention at 4-month postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Magee Women's Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Heather M Joseph, DO
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Hamilton D. Epilepsy and army physicians. J R Army Med Corps. 1986 Oct;132(3):178-9. No abstract available.