MomMA Intervention for ADHD

(MomMA Trial)

Overseen By Michelle Wilson, Research Coordinator

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Substance use, Intellectual disability, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 15 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new behavioral program called the MomMA Intervention, designed to help pregnant individuals manage ADHD and related symptoms during and after pregnancy. Researchers aim to compare the program's effectiveness to usual care and assess its usability in real-life settings. Suitable participants have been diagnosed with ADHD, are between 14 and 22 weeks pregnant, and speak English.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance care for pregnant individuals with ADHD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this behavioral program is safe for pregnant individuals with ADHD?

In a previous study, researchers developed the MomMA program to help pregnant individuals manage ADHD. Specific safety information for the MomMA program is not yet available, as the trial is in an early stage, which means limited safety data exists at this time. Generally, early programs like this are considered low-risk because they focus on teaching skills rather than using medications. For any concerns, discussing them with the trial coordinators or a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MomMA Intervention for ADHD because it focuses on empowering mothers with strategies to effectively support their children, potentially transforming family dynamics as part of the treatment process. Unlike traditional ADHD treatments that often rely on medication or behavioral therapy targeting the child directly, the MomMA Intervention aims to enhance parental involvement and skills, which could lead to more sustainable, long-term improvements in managing ADHD symptoms. This approach is particularly promising as it offers a novel way to address the condition by fostering a supportive home environment, which could complement existing treatments and lead to better outcomes for families.

What evidence suggests that the MomMA Intervention is effective for managing ADHD in pregnancy?

Research has shown that training programs for parents can help children with ADHD. These programs may improve children's behavior and reduce parents' stress, even boosting their confidence. Studies have found these programs effective, but if mothers have ADHD symptoms, improvements might be limited. Overall, training parents in behavior management is a promising way to manage ADHD symptoms in children. This trial will evaluate the MomMA Intervention, designed to support mothers with ADHD symptoms. Although data on pregnant individuals with ADHD is limited, these findings suggest that the MomMA Intervention could be beneficial in this situation. ^{6 7 8 9 10}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for pregnant individuals diagnosed with ADHD. It's designed to help them manage their symptoms during pregnancy and after giving birth. Participants should be currently receiving standard ADHD care, but those with certain psychiatric conditions or substance abuse issues may not qualify.

Inclusion Criteria

I am 18 years old or older.

Meets full DSM-5 criteria for ADHD

Is between 14- and 22-weeks of gestation

Exclusion Criteria

Substance use disorders requiring dual diagnosis treatment

Intellectual disability

Bipolar disorder, psychosis, and major depressive disorder with suicidal ideation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MomMA behavioral intervention or treatment as usual (TAU) for managing ADHD symptoms during pregnancy

15 weeks

Post Intervention Assessment

Assessment of intervention acceptability, feasibility, and appropriateness, as well as ADHD symptom severity and functional impairment

1 week

Follow-up

Participants are monitored for clinical outcomes, including maternal ADHD symptom severity, parent-child attachment, and infant behavior

4-5 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• MomMA Intervention

Trial Overview The study compares a new behavioral program called MomMA Intervention, which focuses on managing ADHD in pregnancy and postpartum, against the usual treatment methods (TAU). The trial will assess how well the intervention works and how feasible it is in real-world medical settings.

How Is the Trial Designed?

Group I: Treatment As Usual (TAU) Experimental Treatment 1 Intervention

Treatment will be determined by participant and their medical and behavioral health providers.

Group II: MomMA Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

University of Maryland, College Park

Collaborator

Trials

163

Recruited

46,800+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6544776/

Parent training interventions for Attention Deficit Hyperactivity ... Parent training may have a positive effect on the behaviour of children with ADHD. It may also reduce parental stress and enhance parental confidence. However, ...

2. journals.sagepub.com journals.sagepub.com/doi/10.1177/27546330251351057

Effectiveness of Parent Training Programmes on Child ... This systematic review examines the efficacy of parent training for children with attention deficit hyperactivity disorder (ADHD) aged ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08431-z

Efficacy of behavioural parent training on attachment security ... Behavioural parent training (BPT) is a psychosocial intervention designed for children with attention deficit hyperactivity disorder (ADHD).

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12049444/

Does maternal ADHD reduce the effectiveness of parent ... Conclusions: High levels of maternal ADHD symptoms limit the improvement shown by children with ADHD after a program of PT. This effect was unrelated to other ...

5. ejhc.journals.ekb.eg ejhc.journals.ekb.eg/article_285164_7f79f9f6db32eff5edab6577e00770a6.pdf

548 Effectiveness of Intervention Guidelines on Mothers of ... Conclusion: The intervention guidelines were effective in improving mothers' knowledge and reported practices regarding their children with attention deficit ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12563816/

Quality of Life in Mothers of Children with ADHD What are the main findings? Mothers of children with ADHD typically displayed a reduced quality of life across physical, psychological, ...

7. yfrp.pitt.edu yfrp.pitt.edu/MomMA

Moms Managing ADHD (MomMA) Study Outcomes from this study could provide information regarding the best way to treat people with ADHD during pregnancy. The MomMA study is currently enrolling ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06540547/moms-managing-attention-deficit-hyperactivity-disorder-adhd-study

Moms Managing Attention-Deficit/Hyperactivity Disorder ... The study will develop and test a behavioral program for pregnant individuals with Attention-Deficit/Hyperactivity Disorder (ADHD).

9. acamh.onlinelibrary.wiley.com acamh.onlinelibrary.wiley.com/doi/10.1111/jcpp.12443

Does intensive multimodal treatment for maternal ADHD ... Safety outcomes were evaluated in the safety set (SAF) of dyads in which the mother received at least one intervention (MPH, GPT, or CM) and ...

10. psychiatrist.com psychiatrist.com/jcp/sequencing-stimulant-medication-behavioral-parent-training-multiplex-adhd-families-pilot-smart/

Sequencing Stimulant Medication and Behavioral Parent ... All 3 sequences involving medication demonstrated similar impact on maternal ADHD symptoms (effect sizes ranged from −0.32 to −0.48). The BPT- ...