ADHDMomMANCT07001293
Expectant Moms Managing Attention-Deficit/ Hyperactivity Disorder
A study testing MomMA Intervention and Treatment as Usual (TAU) in people with ADHD and Perinatal, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- ADHD, Perinatal, Behavioral Intervention
- What is being tested?
- MomMA Intervention and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Melissa Glader, LCSW, 412-641-1238, gladerm@upmc.edu
About this study
Official title: Supporting Expectant Mothers With ADHD Through the Transition to Parenthood: A Pilot RCT
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.
Read the 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.
- Conditions
- ADHD, Perinatal, Behavioral Intervention
- Being tested
- MomMA Intervention, Treatment as Usual (TAU)
- Keywords
- ADHD, Pregnancy, Perinatal Mental Health, Behavioral Intervention, Parenting, Emotion Regulation, Executive Functioning
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MomMA InterventionBehavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| MomMA Intervention | Experimental | Not described Receives: Behavioral: MomMA Intervention |
| Treatment As Usual (TAU) | Other | Treatment will be determined by participant and their medical and behavioral health providers. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post Intervention (36 weeks gestational age) and Postpartum follow-up (4-5 months postpartum)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Postpartum follow-up (4-5 months postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start26 Apr 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, College Park
- Responsible party
- Principal investigator, Heather Joseph, University of Pittsburgh
- Investigators
- Heather M Joseph, DO Assistant Professor of Psychiatry and Pediatrics, Principal investigator, University of PittsburghAndrea Chronis-Tuscano, PhD Joel & Kim Feller Endowed Professor, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001293
- Sponsor's protocol ID
- STUDY25030051
- Acronym
- MomMA
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data collected during the trial will be shared, after deidentification, via the NIMH National Data Archive.
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. Epub 2013 Mar 11.
PubMed 23477479Joseph 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.
PubMed 34937412
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Expectant Mothers With ADHD Through the Transition to Parenthood: A Pilot RCT
- ClinicalTrials.gov ID
- NCT07001293
- Acronym / sponsor ID
- MomMA / STUDY25030051
- Conditions
- ADHD, Perinatal, Behavioral Intervention
- Keywords
- ADHD, Pregnancy, Perinatal Mental Health, Behavioral Intervention, Parenting, Emotion Regulation, Executive Functioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Maryland, College Park
- Study start
- 26 Apr 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MomMA Intervention | Experimental | Behavioral: MomMA Intervention |
| Treatment As Usual (TAU) | Other | Other: Treatment as Usual (TAU)Treatment will be determined by participant and their medical and behavioral health providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MomMA InterventionThe 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. | Behavioural | MomMA Intervention |
| 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. | Other | Treatment As Usual (TAU) |
Primary outcome
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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 23477479Chronis-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.
- Background: PubMed 34937412Joseph 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.
- Individual participant dataSharing planned: Yes. Individual participant data collected during the trial will be shared, after deidentification, via the NIMH National Data Archive.
Related trials for ADHD
Not yet recruitingObservational study
Phase 1: Thrive Together: A Feasibility and Acceptability Evaluation of Peer Mentoring for High Schoolers With ADHD and Their Caregivers
Attention-Deficit/Hyperactivity Disorder (ADHD)
RecruitingPhase 3
A Long-term Trial of EB-1020 in Adult Patients With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 2/3
Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 4
AWARE: Management of ADHD in Autism Spectrum Disorder
ADHD, Autism Spectrum Disorder
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather M Joseph, DO Assistant Professor of Psychiatry and Pediatrics principal investigator
University of Pittsburgh
Andrea Chronis-Tuscano, PhD Joel & Kim Feller Endowed Professor principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MomMA Intervention and Treatment as Usual (TAU) in people with ADHD and Perinatal, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Wilson, Research Coordinator (412-420-8309, wilsonm13@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Acceptability (time frame: Post Intervention (36 weeks gestational age)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07001293, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.