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| Name | Class |
|---|---|
| University of Maryland, College Park | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MomMA Intervention | Experimental |
| |
| Treatment As Usual (TAU) | Other | Treatment will be determined by participant and their medical and behavioral health providers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MomMA Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Post Intervention (36 weeks gestational age) |
| 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). | Post Intervention (36 weeks gestational age) |
| 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). | Post Intervention (36 weeks gestational age) |
| ADHD Symptom Severity | 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. | Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum) |
| ADHD Functional Impairment | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Attachment | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Executive Function | Participant will self-report on executive function using the Barkley Deficits in Executive Function Scale (BDEFS). Items are rated from 1 (Never or rarely) to 4 (Very often). Executive Functioning will be assessed as a Target Mechanism. These data will be used in exploratory analyses to determine change from baseline to post-intervention, and whether this change is related to change in clinical outcome measures. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Wilson, Research Coordinator | Contact | 412-420-8309 | wilsonm13@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Heather M Joseph, DO Assistant Professor of Psychiatry and Pediatrics | University of Pittsburgh | Principal Investigator |
| Andrea Chronis-Tuscano, PhD Joel & Kim Feller Endowed Professor | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Magee-Womens Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23477479 | Background | 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. | |
| 34937412 |
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Individual participant data collected during the trial will be shared, after deidentification, via the NIMH National Data Archive.
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Data will be shared upon publication or 1 year after the grant end date. Data will be available indefinitely.
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000068356 | Self-Control |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as Usual (TAU) | Other | Participants will receive treatment as usual, including but not limited to medication and behavioral therapy. No participation in treatment is required. |
|
| Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum) |
| Perinatal Mood/Distress | 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. | Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum) |
| Postpartum follow-up (4-5 months postpartum) |
| Home Environment | 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. | Postpartum follow-up (4-5 months postpartum) |
| Infant Behavior | 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). | Postpartum follow-up (4-5 months postpartum) |
| Parent-Child Interaction | Parent affect, warmth, responsiveness, engagement, sensitivity, indifference, intrusiveness, and infant affect, engagement, attentiveness will be rated using the Global Ratings of Mother-Infant Interaction. | Postpartum follow-up (4-5 months postpartum) |
| Change from baseline to Post Intervention (36 weeks gestational age) |
| Parent Emotion Regulation | Participant will self-report on executive function using the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF). Items are rated from 1 (Almost never, 0-10%) to 5 (Almost always, 91-100%). Emotion Regulation will be assessed as a Target Mechanism. These data will be used in exploratory analyses to determine change from baseline to post-intervention, and whether this change is related to change in clinical outcome measures. | Change from Baseline to Post Intervention (36 weeks gestational age) |
| Background |
| 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. |
| D012919 | Social Behavior |
| D001519 | Behavior |