Expectant Moms Managing Attention-Deficit/ Hyperactivity Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
meets full DSM-5 criteria for ADHD
is between 14- and 22-weeks of gestation
18 years of age or older
English speaking
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
MomMA Intervention
BehavioralThe 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.
Treatment as Usual (TAU)
Other interventionParticipants will receive treatment as usual, including but not limited to medication and behavioral therapy. No participation in treatment is required.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: MomMA InterventionExperimental treatment 1 intervention
Group B: Treatment As Usual (TAU)Other 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Post Intervention (36 weeks gestational age)2
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).
Time frame
Post Intervention (36 weeks gestational age)3
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).
Time frame
Post Intervention (36 weeks gestational age)4
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.
Time frame
Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum)Secondary outcomes
1
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.
Time frame
Postpartum follow-up (4-5 months postpartum)2
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.
Time frame
Postpartum follow-up (4-5 months postpartum)3
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).
Time frame
Postpartum follow-up (4-5 months postpartum)4
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.
Time frame
Postpartum follow-up (4-5 months postpartum)Other outcomes
1
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.
Time frame
Change from baseline to Post Intervention (36 weeks gestational age)2
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.
Time frame
Change from Baseline to Post Intervention (36 weeks gestational age)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
University of Maryland, College Park
Collaborator
Source ClinicalTrials.gov