About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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)
Disqualifiers
(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.
Trial design
Single group
Treatments tested in this trial
MomMA Intervention
BehavioralParents 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Sponsors and contacts
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University of Pittsburgh
Lead sponsor
YourMomCares Foundation
Collaborator