What side effects are associated with this type of intervention?

Group-based, relationship-focused therapies like Virtual Mom Power (MP) generally have minimal physical side effects but can sometimes lead to emotional discomfort as participants confront challenging issues. Cognitive-behavioral therapy (CBT) and family-based treatments may cause temporary increases in anxiety or distress as individuals work through difficult emotions and behaviors. Common pharmacological treatments for mental illness, such as antidepressants and antipsychotics, can have side effects including weight gain, drowsiness, gastrointestinal issues, and, in some cases, more severe effects like metabolic changes or movement disorders. It is important for patients to discuss potential side effects with their healthcare providers to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved various treatments for mental illnesses, including pharmacological and non-pharmacological interventions. While specific group-based, relationship-focused multifamily preventive interventions like Virtual Mom Power (MP) are less commonly highlighted in FDA approvals, there are several approved drugs for mental health conditions. These include antidepressants (e.g., fluoxetine, sertraline), antipsychotics (e.g., risperidone, quetiapine), and mood stabilizers (e.g., lithium, divalproex sodium). Additionally, the FDA has approved psychotherapeutic approaches such as cognitive-behavioral therapy (CBT) and family-based therapies, which align with the preventive and relationship-focused aspects of MP.

What other types of research exist?

Promising, novel alternatives to Virtual Mom Power (MP) for mental illness patients in 2024 include: 1) Texting 4 Relapse Prevention (T4RP), a text messaging-based relapse prevention program for schizophrenia and schizoaffective disorder, which has shown high patient acceptability and positive outcomes in pilot trials. 2) Smartphone-assisted cognitive-behavioral therapy (CBT) for binge eating disorder, which has demonstrated efficacy in randomized controlled trials. 3) Collaborative care models integrating telemedicine for depression, which have shown improved patient outcomes through enhanced patient-provider communication and coordinated care.

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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

Must not have

Mother is not biological mother

Diagnosis of a heart condition in the mother or the child

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Virtual Mom Power, an online program for mothers with mental health issues and parenting stress. It aims to improve their well-being by providing social support, parenting education, self-care techniques, guided parent-child activities, and connecting them to care resources.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My mother is not my biological mother.

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Either I or my child has been diagnosed with a heart condition.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline child behavior at 6 month follow up.

Change from baseline child behavior at post-intervention

Depressive Symptoms

+3 more

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Group-based, relationship-focused multifamily preventive interventions, such as Virtual Mom Power (MP), work by enhancing social support, teaching coping skills, and improving family dynamics. These interventions often include psychoeducation and cognitive-behavioral techniques. This approach is significant for mental illness patients as it addresses both individual symptoms and the broader social and familial context, which can be crucial for long-term recovery and resilience.

Unveiling mechanisms of change in digital interventions for depression: Study protocol for a systematic review and individual participant data meta-analysis.Remote Collaborative Care With Off-Site Behavioral Health Care Managers: A Systematic Review of Clinical Trials.