ADHD, Behavioral Intervention, Perinatal
Conditions
Keywords
ADHD, Pregnancy, Perinatal Mental Health, Behavioral Intervention, Parenting, Emotion Regulation, Executive Functioning
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.
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
BEHAVIORALMomMA 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.
OTHERTreatment as Usual (TAU)
Participants will receive treatment as usual, including but not limited to medication and behavioral therapy. No participation in treatment is required.
Sponsors
University of Pittsburgh
University of Maryland, College Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. meets full DSM-5 criteria for ADHD 2. is between 14- and 22-weeks of gestation 3. 18 years of age or older 4. English speaking 5. Lives in Pennsylvania
Exclusion criteria
1. substance use disorders requiring dual diagnosis treatment 2. intellectual disability 3. bipolar disorder, psychosis, and major depressive disorder with suicidal ideation 4. the following high complexity medical conditions during pregnancy: maternal cancer, multiples, placenta accreta, and/or fetus known to have a severe congenital condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability | Post Intervention (36 weeks gestational age) | 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). |
| Intervention Feasibility | Post Intervention (36 weeks gestational age) | 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). |
| Intervention Appropriateness | Post Intervention (36 weeks gestational age) | 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). |
| ADHD Symptom Severity | Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum) | 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. |
| ADHD Functional Impairment | Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum) | 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. |
| Perinatal Mood/Distress | Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attachment | Postpartum follow-up (4-5 months postpartum) | Maternal Postnatal Attachment Scale (MPAS) is a 19-item self-report questionnaire, and measures Mother to Baby Attachment during pregnancy. Questions explore maternal interest in and preoccupation with pregnancy, as well as the respondent's emotions towards the growing infant. Similar to the MPAS, each item is equally weighted and has five answer choices, with total scores ranging from 19-95. |
| Home Environment | Postpartum follow-up (4-5 months postpartum) | Using the Confusion, Hubbub, and Order Scale, a 15-item self-report scale rated from 1 (Very much like your own home) to 4 (Not at all like your own home). Total scores range from 15-60, with higher scores indicating more chaotic homes. |
| Infant Behavior | Postpartum follow-up (4-5 months postpartum) | Infant behavior (temperament and sleep) will be reported by mothers on the Infant Behavior Questionnaire-Short Form (IBQ-R-SF) and the Brief Infant Sleep Questionnaire (BISQ). |
| Parent-Child Interaction | Postpartum follow-up (4-5 months postpartum) | Parent affect, warmth, responsiveness, engagement, sensitivity, indifference, intrusiveness, and infant affect, engagement, attentiveness will be rated using the Global Ratings of Mother-Infant Interaction. |
Countries
United States
Contacts
CONTACTMichelle Wilson, Research Coordinator
PRINCIPAL_INVESTIGATORHeather M Joseph, DO Assistant Professor of Psychiatry and Pediatrics
University of Pittsburgh
PRINCIPAL_INVESTIGATORAndrea Chronis-Tuscano, PhD Joel & Kim Feller Endowed Professor
University of Maryland
Outcome results
None listed