MomMA Intervention for ADHD

(MomMA Trial)

Recruiting at 1 trial location

Overseen By Michelle Wilson

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Substance use disorder, Intellectual disability, Severe mental illness, High risk pregnancies, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The study will develop and test a behavioral program for pregnant individuals with Attention-Deficit/Hyperactivity Disorder (ADHD). This behavioral program will include skills for managing ADHD and related symptoms during pregnancy and after delivery and will be taught by a behavioral therapist in OB care settings.

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.

Is the MomMA Intervention for ADHD safe for humans?

There is limited information on the safety of ADHD medications during pregnancy and breastfeeding, but the risk of harm appears to be low, especially for methylphenidate. However, there is some evidence of increased rates of fetal loss with methylphenidate, and interactions with herbal remedies like St. John's wort may cause adverse effects. ^{1 2 3 4 5}

How does the MomMA Intervention treatment for ADHD differ from other treatments?

The MomMA Intervention is unique because it focuses on treating mothers with ADHD to improve both their own symptoms and their children's ADHD symptoms. It combines stimulant medication and behavioral parent training, offering a flexible approach that can be adjusted based on individual needs, which is different from standard treatments that typically focus only on the child. ^{6 7 8 9 10}

What data supports the effectiveness of the MomMA Intervention treatment for ADHD?

Research shows that behavioral parent training, a component of the MomMA Intervention, is effective in improving child behavior and parent-child interactions in families with ADHD. Additionally, nursing case-management interventions that focus on family education and structure can complement behavioral therapy, potentially enhancing its effectiveness. ^{6 11 12 13 14}

Who Is on the Research Team?

Heather M Joseph, DO

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for pregnant individuals who have ADHD. It's designed to help them manage their symptoms during and after pregnancy. Participants will learn skills from a behavioral therapist in an OB care setting.

Inclusion Criteria

Meet full DSM-5 criteria for ADHD

Will deliver at the University of Pittsburgh Medical Center (UPMC) Magee Women's Hospital (MWH)

I am between 20 and 32 weeks pregnant.

Exclusion Criteria

Intellectual disability

Active substance use disorder

Other severe mental illness, including bipolar disorder, psychosis, and major depressive disorder with suicidal ideation or requiring higher level of care (inpatient or partial/intensive outpatient)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MomMA intervention, a behavioral program for managing ADHD during pregnancy and after delivery

4 months

Regular sessions with a behavioral therapist

Follow-up

Participants are monitored for intervention acceptability, feasibility, and appropriateness, as well as parent and child outcomes

4 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• MomMA Intervention

Trial Overview The study is testing the 'MomMA Intervention', a behavioral program aimed at helping pregnant individuals with ADHD cope with their condition through various stages of motherhood.

How Is the Trial Designed?

Group I: MomMA Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

YourMomCares Foundation

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

Behavioral parent training interventions are effective nonpharmacologic treatments for ADHD, showing positive impacts on child compliance, ADHD symptoms, and parent-child interactions based on numerous clinical trials and meta-analyses.

These interventions are categorized as well-established, evidence-based treatments for ADHD, highlighting their importance in managing the disorder in school-age children within the home setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior management for school-aged children with ADHD. Pfiffner, LJ., Haack, LM.[2021]

In a study involving 12 parents with ADHD and their children, behavioral parent training (BPT) showed improvements in both parent and child behavior, indicating that BPT can be beneficial for parents managing ADHD symptoms.

Despite the positive effects of BPT on child behavior, the study found limited improvements in parent functioning, suggesting that while BPT is helpful, more research is needed to explore psychosocial treatments for adults with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating parents with attention-deficit/hyperactivity disorder: the effects of behavioral parent training and acute stimulant medication treatment on parent-child interactions. Babinski, DE., Waxmonsky, JG., Pelham, WE.[2021]

The study involved 144 mother-child pairs, where treatment for maternal ADHD was evaluated to see if it improved the effectiveness of behavioral parent training for children's ADHD.

After 3 months of treatment for maternal ADHD, the results will help determine if addressing maternal ADHD can enhance outcomes for children with ADHD, highlighting the importance of treating parental conditions in managing child behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled multicentre trial on the treatment for ADHD in mothers and children: enrolment and basic characteristics of the study sample. Jans, T., Graf, E., Jacob, C., et al.[2022]

A 12-month nursing case-management intervention for families of children with ADHD showed moderate improvements in family function, particularly in behavior control and family satisfaction, compared to control families.

While the intervention did not significantly reduce maternal stress or improve child behavior outcomes, it supports the use of behavioral therapy as a primary treatment for ADHD, suggesting that family education and structure can enhance overall treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Impact of a Randomized Clinical Trial to Improve Family Function, Reduce Maternal Stress and Improve Child Outcomes in Families of Children with ADHD. Churchill, SS., Leo, MC., Brennan, EM., et al.[2019]

A pilot study involving 35 mothers with ADHD and their children showed that both stimulant medication and behavioral parent training are acceptable and feasible treatments, with mothers preferring combination therapy, especially starting with medication.

The study highlights that treating mothers with ADHD can positively impact their children's ADHD symptoms, suggesting that addressing parental ADHD is a crucial step in improving family health and functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piloting a Sequential, Multiple Assignment, Randomized Trial for Mothers with Attention-Deficit/Hyperactivity Disorder and Their At-Risk Young Children. Schoenfelder, EN., Chronis-Tuscano, A., Strickland, J., et al.[2023]

Women with ADHD face unique challenges, particularly during pregnancy and breastfeeding, as they may require pharmacologic treatment, such as prescription stimulants, despite the uncertainty regarding the safety of these medications for the developing fetus.

Clinicians should be aware of the potential for stimulant misuse among women with ADHD, as this can complicate treatment and management, highlighting the need for careful assessment and guidance in prescribing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention-Deficit Hyperactivity Disorder: Clinical Considerations for Women. Marraccini, ME., Weyandt, LL., Gudmundsdottir, BG., et al.[2018]

ADHD medications, particularly methylphenidate, are classified as 'pregnancy category C' by the FDA, indicating insufficient data on their safety during pregnancy, but current evidence suggests a low risk of fetal malformation and minimal medication transfer through breast milk.

Discontinuing ADHD treatment during pregnancy may pose risks to both the mother and baby, and discussions about treatment should be transparent, weighing the potential risks of continuing medication against the risks of inadequate treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ADHD treatment and pregnancy. Besag, FM.[2021]

A review of adverse event reports (AERs) found that interactions between herbal remedies and ADHD medications, particularly involving St. John's wort and methylphenidate, could lead to potential adverse effects in pediatric patients.

Out of 23 AERs identified, only five were detailed enough to assess causality, with one interaction deemed probable and another possible, highlighting the need for better reporting quality and further research on these interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural Health Product-Drug Interaction Causality Assessment in Pediatric Adverse Event Reports Associated with Attention-Deficit/Hyperactivity Disorder Medication. Mazhar, H., Foster, BC., Necyk, C., et al.[2021]

A review of 43 studies involving around 7000 children found that common adverse drug reactions (ADRs) from ADHD medications included decreased appetite, gastrointestinal pain, and headaches, primarily reported by children or their parents.

Most studies reported low rates of serious ADRs, but many children dropped out due to serious reactions, suggesting that the actual incidence of serious ADRs may be higher, highlighting the need for long-term safety studies on ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. Aagaard, L., Hansen, EH.[2021]

Stimulant medications for ADHD do not seem to cause congenital malformations in babies, but there are still uncertainties regarding other potential risks during pregnancy.

Clinicians and patients should carefully weigh the risks of taking these medications against the risks associated with untreated ADHD, such as impaired driving and difficulties in work performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Attention Deficit Hyperactivity Disorder During Pregnancy. Baker, AS., Freeman, MP.[2019]

An integrated intervention targeting both parenting and depressive symptoms in mothers of children with ADHD showed small to moderate improvements in maternal depressive symptoms and child behavior compared to standard behavioral parent training, based on a study of 98 mothers.

While the integrated intervention was effective in reducing negative parenting and child impairment, the standard behavioral parent training resulted in greater improvements in observed positive parenting at follow-up, suggesting that both approaches have unique benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and preliminary evaluation of an integrated treatment targeting parenting and depressive symptoms in mothers of children with attention-deficit/hyperactivity disorder. Chronis-Tuscano, A., Clarke, TL., O'Brien, KA., et al.[2021]

A study using structural equation modeling on a community sample of families with children and adolescents with ADHD found that maternal distress plays a key role in mediating the relationship between child behavior problems and family conflict.

The findings highlight the importance of supporting mothers in families affected by ADHD, as their distress can significantly impact family dynamics and conflict levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling ADHD child and family relationships. Kendall, J., Leo, MC., Perrin, N., et al.[2019]

Mothers of children with ADHD who exhibit ADHD tendencies experience significantly poorer mental health and higher parenting stress, particularly related to understanding their child's disorder and coping with their needs, compared to mothers without ADHD tendencies.

The study, which surveyed 149 mothers, suggests that recognizing maternal ADHD tendencies is crucial for providing tailored support to improve the mental health and well-being of these mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental Health and Psychosocial Status in Mothers of Children with Attention Deficit Hyperactivity Disorder (ADHD): Differences by Maternal ADHD Tendencies : Mental Health and Psychosocial Status in Mothers of ADHD Children. Marumoto, T., Monma, T., Sawae, Y., et al.[2023]

The online self-help program significantly improved child behavior, including reductions in hyperactivity, inattention, and aggression, as reported by mothers and teachers, in a randomized control trial with 53 parents of preschoolers with ADHD symptoms.

Parents also experienced enhanced parenting skills and well-being, with lasting effects on maternal stress, satisfaction, and self-efficacy observed at a 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An RCT of an Online Parenting Program for Parents of Preschool-Aged Children With ADHD Symptoms. Franke, N., Keown, LJ., Sanders, MR.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Behavior management for school-aged children with ADHD. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Treating parents with attention-deficit/hyperactivity disorder: the effects of behavioral parent training and acute stimulant medication treatment on parent-child interactions. [2021]

3. Austria pubmed.ncbi.nlm.nih.gov

A randomized controlled multicentre trial on the treatment for ADHD in mothers and children: enrolment and basic characteristics of the study sample. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Longitudinal Impact of a Randomized Clinical Trial to Improve Family Function, Reduce Maternal Stress and Improve Child Outcomes in Families of Children with ADHD. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Piloting a Sequential, Multiple Assignment, Randomized Trial for Mothers with Attention-Deficit/Hyperactivity Disorder and Their At-Risk Young Children. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Attention-Deficit Hyperactivity Disorder: Clinical Considerations for Women. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

ADHD treatment and pregnancy. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Natural Health Product-Drug Interaction Causality Assessment in Pediatric Adverse Event Reports Associated with Attention-Deficit/Hyperactivity Disorder Medication. [2021]

9. New Zealand pubmed.ncbi.nlm.nih.gov

The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Management of Attention Deficit Hyperactivity Disorder During Pregnancy. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Development and preliminary evaluation of an integrated treatment targeting parenting and depressive symptoms in mothers of children with attention-deficit/hyperactivity disorder. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Modeling ADHD child and family relationships. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Mental Health and Psychosocial Status in Mothers of Children with Attention Deficit Hyperactivity Disorder (ADHD): Differences by Maternal ADHD Tendencies : Mental Health and Psychosocial Status in Mothers of ADHD Children. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

An RCT of an Online Parenting Program for Parents of Preschool-Aged Children With ADHD Symptoms. [2022]