Expectant Moms Managing Attention-Deficit/ Hyperactivity Disorder

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.

Intervention Acceptability

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.