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Behavioral Intervention

Virtual Mom Power for Family Support

N/A

Waitlist Available

Led By Sarah A Gray, PhD

Research Sponsored by Tulane University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Maternal age of at least 18 years

Child age is between 3-5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing whether a virtual program called "Mom Power" can help prevent problems in families.

Who is the study for?

This trial is for mothers aged at least 18, living in the New Orleans area with a child aged 3-5. They must be primary caregivers, speak English, and enrolled in certain assistance programs like SNAP or Medicaid. It's not for those with heart conditions, pacemakers, children with autism/global delays, active substance use or psychosis in the mother, or non-biological mothers.Check my eligibility

What is being tested?

The study tests 'virtual Mom Power (MP)', a group-based program aimed at helping high-adversity moms and kids by focusing on relationships. Participants will either receive MP or just informational mailings about it to see which helps more.See study design

What are the potential side effects?

Since this intervention involves educational and supportive services rather than medical treatments, traditional side effects are not expected; however participants may experience emotional discomfort during discussions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My child is between 3 to 5 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline child behavior at 6 month follow up.

Change from baseline child behavior at post-intervention

Depressive Symptoms

+3 more

Secondary outcome measures

Change in Working Models from baseline to post-intervention

Change in child Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention

Change in child resting Respiratory Sinus Arrhythmia from baseline to post-intervention

+13 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 Intervention

The experimental arm of Virtual Mom Power is a manualized multi-family group intervention consisting of 10, 90-minute virtual group + 2 individual sessions led by two co-facilitators. The curriculum includes 5 core components: (1) Attachment-Focused Parenting Education; (2) Self-Care; (3) Parenting Practice; (4) Social Support; & (5) Connection to Resources. Individual sessions combine motivational interviewing with MP core components and focus on identifying goals and barriers. We will work with mothers in individual coaching to problem-solve childcare and privacy during group time. Weekly between-group phone/text check-ins are also a part of the curriculum, used to strengthen connection, build trust, ensure safety, and assess basic needs. Data regarding attendance will be recorded and total dosage examined in treatment effects.

Group II: Informational controlActive Control1 Intervention

The control arm of this study consists of two individual sessions with mothers, along with 10 weeks of virtual informational mailings. The mailings will contain Mom Power curriculum about attachment-based parenting and self-care. The individual sessions will focus on individual goal-setting related to parenting and reflection on the parent-child relationship. The control group does not include the components of social support, affect regulation skills coaching, or guided parent-child interaction that are part of the experimental arm.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,267 Total Patients Enrolled

Tulane UniversityLead Sponsor

115 Previous Clinical Trials

226,002 Total Patients Enrolled

Sarah A Gray, PhDPrincipal InvestigatorTulane University

1 Previous Clinical Trials

Media Library

Mom Power (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05129397 — N/A

Mental Illness Research Study Groups: Treatment, Informational control

Mental Illness Clinical Trial 2023: Mom Power Highlights & Side Effects. Trial Name: NCT05129397 — N/A

Mom Power (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05129397 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being admitted to this experiment?

"Affirmative. On clinicaltrials.gov, it is indicated that this trial is actively seeking 500 volunteers from a single site since its posting on November 1st 2021 and latest update on the 29th of November 2022."

Answered by AI

What is the current size of the cohort participating in this clinical trial?

"That is correct. The information compiled on clinicaltrials.gov affirms that this experiment, initially posted on November 1st 2021, is currently enrolling individuals. This research requires 500 people to be recruited from a singular medical centre."

Answered by AI

What can be anticipated as the eventual outcome of this research endeavor?

"The primary objective of this 6-month follow-up trial is to assess changes in maternal depressive symptoms from baseline. Notably, secondary outcomes include evaluating shifts in the parent child relationship (using PSI-SF), assessing alterations to parental social support (with MSPSS) and measuring modifications to emotional regulation (via DERS)."

Answered by AI