Expectant Moms Managing Attention-Deficit/ Hyperactivity Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MomMA Intervention, Treatment as Usual (TAU).
- Who it may be relevant to
- Registry conditions: ADHD, Perinatal, Behavioral Intervention. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Supporting Expectant Mothers With ADHD Through the Transition to Parenthood: A Pilot RCT
Overview
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= 40 pregnant women with ADHD; 20 receiving the behavioral intervention and 20 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.
Interventions
- Behavioral MomMA Intervention
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. - Other Treatment as Usual (TAU)
Participants will receive treatment as usual, including but not limited to medication and behavioral therapy. No participation in treatment is required.
Primary outcome measures
- Intervention Acceptability [Time frame: Post Intervention (36 weeks gestational age)]
- Intervention Feasibility [Time frame: Post Intervention (36 weeks gestational age)]
- Intervention Appropriateness [Time frame: Post Intervention (36 weeks gestational age)]
- ADHD Symptom Severity [Time frame: Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum)]
- ADHD Functional Impairment [Time frame: Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum)]
- Perinatal Mood/Distress [Time frame: Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum)]
Secondary outcome measures (4)
- Attachment [Time frame: Postpartum follow-up (4-5 months postpartum)]
- Home Environment [Time frame: Postpartum follow-up (4-5 months postpartum)]
- Infant Behavior [Time frame: Postpartum follow-up (4-5 months postpartum)]
- Parent-Child Interaction [Time frame: Postpartum follow-up (4-5 months postpartum)]
Eligibility criteria
Inclusion criteria
- meets full DSM-5 criteria for ADHD
- is between 14- and 22-weeks of gestation
- 18 years of age or older
- English speaking
- Lives in Pennsylvania
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UPMC Magee-Womens Hospital — Pittsburgh
Publications
- 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. Epu PMID 23477479
- 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
Identifiers
NCT: NCT07001293 · STUDY25030051