Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Mom Power With High-Adversity Mothers and Children (MPHAMC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05129397
Recruitment Status : Recruiting
First Posted : November 22, 2021
Last Update Posted : November 22, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sarah Gray, Tulane University

Brief Summary:
This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily preventive intervention.

Condition or disease Intervention/treatment Phase
Psychopathology Behavioral: Mom Power Behavioral: Mom Power Informational Mailing Not Applicable

Detailed Description:
This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily intervention with previously demonstrated effectiveness improving maternal mental health and parenting stress in randomized controlled trials. vMP targets 5 core components: 1) enhancing social support; 2) attachment-based parenting education; 3) self-care, including affect regulation; 4) guided parent-child interactions, and 5) connecting to care. Eligible and enrolled participants will be randomized to receive the 10 week group-based intervention or 10 weeks of informational mailings; both groups will receive individual home-based sessions. Outcomes include maternal social support, psychopathology, sensitive parenting, child psychopathology, two-generational biobehavioral self-regulation targets (Respiratory Sinus Arrhythmia), parent and child emotion and behavior regulation, and dyadic behavioral and physiological synchrony. Assessments will occur at intake, post, and 6 months following the group.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There are two arms: an experimental group receiving the Mom Power group intervention over 10 weeks, and a control group that will receive informational virtual mailings over 10 weeks. Treatment delivery will be consistent with the Mom Power manual and informational mailings will contain content from the Mom Power Curriculum.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : May 30, 2026
Estimated Study Completion Date : May 30, 2026

Arm Intervention/treatment
Experimental: Treatment
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.
Behavioral: Mom Power
Virtual Mom Power is a manualized multi-family group intervention consisting of 10 virtual group + 2 individual sessions led by two masters-level co-facilitators. Virtual groups are 90 minutes, following a structured format via secure HIPAA compatible video platform. 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. 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.

Active Comparator: Informational control
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.
Behavioral: Mom Power Informational Mailing
This active comparison condition intervention includes two individual sessions along with 10 weeks of informational mailing with content related to Mom Power core concepts.




Primary Outcome Measures :
  1. Change from baseline maternal depressive symptoms at post-intervention [ Time Frame: At completion of intervention, approximately 3 months ]
    Mothers will report on their own depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) at baseline, post-intervention, and 6 month follow up; change in sum scale from baseline at post-intervention will be assessed. Higher scores reflect more depressive symptoms.

  2. Change from baseline maternal depressive symptoms at 6 month follow up [ Time Frame: 6 months (follow up) ]
    Mothers will report on their own depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) at baseline, post-intervention, and 6 month follow up; change in sum scale from baseline to 6 month follow up will be assessed. Higher scores reflect more depressive symptoms.

  3. Change from baseline maternal posttraumatic stress symptoms at post-intervention [ Time Frame: At completion of intervention, approximately 3 months ]
    Mothers will report on their own posttraumatic stress symptoms using the Posttraumatic Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5). Sum scales will be assessed at baseline, post-intervention (3 months), and 6 month follow up; change in sum scale from baseline to 3 month follow up will be assessed. Higher scores reflect more posttraumatic stress symptoms.

  4. Change from baseline maternal posttraumatic stress symptoms at 6 month follow up [ Time Frame: 6 months (follow up) ]
    Mothers will report on their own posttraumatic stress symptoms using the Posttraumatic Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5). Sum scales will be assessed at baseline, post-intervention (3 months), and 6 month follow up; change in sum scale from baseline to 6 month follow up will be assessed. Higher scores reflect more posttraumatic stress symptoms.

  5. Change from baseline child behavior at post-intervention [ Time Frame: At completion of intervention, approximately 3 months ]
    Mothers will report on child behavior on the Child Behavior Checklist (CBCL 1.5-5). Sum scores will be used. Higher scores reflect more behavior problems.

  6. Change from baseline child behavior at 6 month follow up. [ Time Frame: 6 months (follow up) ]
    Mothers will report on child behavior on the Child Behavior Checklist (CBCL 1.5-5). Sum scores will be used. Higher scores reflect more behavior problems.


Secondary Outcome Measures :
  1. Change in parenting stress from baseline to post-intervention [ Time Frame: At completion of intervention, approximately 3 months ]
    Mothers will report on their own parenting stress using the Parenting Stress Index - 4, Short Form (PSI-SF); change in the the Total Stress scale from baseline to post-assessment (3 months) will be examined. Higher scores reflect more parenting stress.

  2. Change in parenting stress from baseline to 6 month follow up [ Time Frame: 6 months ]
    Mothers will report on their own parenting stress using the Parenting Stress Index - 4, Short Form (PSI-SF); change in the the Total Stress scale from baseline to follow up (6 months) will be examined. Higher scores reflect more parenting stress.

  3. Change in self-report parent child relationship from baseline to post intervention [ Time Frame: At completion of intervention, approximately 3 months ]
    Mothers will report on their own parenting stress using the Parenting Stress Index - 4, Short Form (PSI-SF); change in the the Parent Child Dysfunctional Interaction scale from baseline to post-assessment (3 months) will be examined. Higher scores reflect more dysfunction.

  4. Change in self-report parent child relationship from baseline to follow up [ Time Frame: 6 months ]
    Mothers will report on their own parenting stress using the Parenting Stress Index - 4, Short Form (PSI-SF); change in the the Parent Child Dysfunctional Interaction scale from baseline to follow up (6 months) will be examined. Higher scores reflect more dysfunction.

  5. Change in maternal social support from baseline to post intervention [ Time Frame: At completion of intervention, approximately 3 months ]
    Mothers will report on their perceived social support a using the Multidimensional Scale of Perceived Social Support (MSPSS). Change from baseline to post intervention (3 months) will be examined. Higher scores reflect more social support.

  6. Change in maternal social support from baseline to follow up [ Time Frame: 6 months ]
    Mothers will report on their perceived social support a using the Multidimensional Scale of Perceived Social Support (MSPSS). Change from baseline to follow up (6 months) will be examined. Higher scores reflect more social support.

  7. Change in observed parenting sensitivity from baseline to post-intervention [ Time Frame: At completion of intervention, approximately 3 months ]
    Parenting sensitivity will be assessed at baseline and post intervention (3 months) with an observational measure. Video tapes of parent-child interactions during a 5-minute period of free play and a 5-minute period of structured interaction with a challenging puzzle will be coded using the Coding Interactive Behavior (CIB) measure. Parenting sensitivity scales will be used. Higher scores reflect more sensitivity.

  8. Change in Working Models from baseline to post-intervention [ Time Frame: At completion of intervention, approximately 3 months ]
    Mothers and evaluators will complete a Working Model of the Child Interview (WMCI) at baseline and post-intervention (3 months) to assess parents' internal working model classifications. Classifications as Balanced, Disengaged, and Distorted will be used. Classification as balance is considered a more adaptive outcome.

  9. Change in maternal emotion regulation from baseline to post-intervention [ Time Frame: At completion of intervention, approximately 3 months ]
    Mothers will report on their difficulties in emotion regulation (Difficulties in Emotion Regulation Scale). Change in the sum score from baseline to post-intervention will be examined. Higher scores reflect more difficulties in emotion regulation.

  10. Change in maternal emotion regulation from baseline to follow up [ Time Frame: 6 months ]
    Mothers will report on their difficulties in emotion regulation (Difficulties in Emotion Regulation Scale). Change in the sum score from baseline to 6 month follow up will be examined. Higher scores reflect more difficulties in emotion regulation.

  11. Change in maternal emotion regulation while parenting from baseline to post intervention [ Time Frame: At completion of intervention, approximately 3 months ]
    Mothers will report on their parenting-specific behavioral self-regulation (Regulating Emotions in Parenthood). Change in the sum score from baseline to post intervention will be examined.

  12. Change in maternal emotion regulation while parenting from baseline to follow up [ Time Frame: 6 months ]
    Mothers will report on their parenting-specific behavioral self-regulation (Regulating Emotions in Parenthood). Change in the sum score from baseline to 6 month follow up will be examined.

  13. Change in maternal resting Respiratory Sinus Arrhythmia from baseline to post-intervention [ Time Frame: At completion of intervention, approximately 3 months ]
    At baseline assessments and at post-intervention assessments, electrocardiogram data will be collected during a 2 minute neutral video tsak. ECG signals will be synchronized at acquisition with video and processed offline using Mindware software; research assistants will visually inspect for missing or erroneously identified R-peaks. Using spectral analysis of interbeat intervals, high-frequency heart rate variability will be extracted to quantify respiratory sinus arrhythmia (RSA) within frequency bandwidths associated with respiration (.15-.40 for mothers) and log-transformed. Change in resting RSA from baseline to post-intervention will be examined. Higher resting RSA is expected post-intervention.

  14. Change in maternal Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention [ Time Frame: At completion of intervention, approximately 3 months ]
    Electrocardiogram data will be collected during a 2 minute baseline neutral video task and a 5 minute parent-child puzzle teaching task. ECG signals will be synchronized at acquisition with video and processed offline using Mindware software; research assistants will visually inspect for missing or erroneously identified R-peaks. Using spectral analysis of interbeat intervals, high-frequency heart rate variability will be extracted to quantify RSA within frequency bandwidths associated with respiration (24-1.04 for children) and log-transformed. Respiratory Sinus Arrhythmia reactivity in response to the puzzle task will be assessed at baseline and post-intervention (3 months)

  15. Change in child resting Respiratory Sinus Arrhythmia from baseline to post-intervention [ Time Frame: At completion of intervention, approximately 3 months ]
    Electrocardiogram data will be collected during a 2 minute baseline neutral video task. ECG signals will be synchronized at acquisition with video and processed offline using Mindware software; research assistants will visually inspect for missing or erroneously identified R-peaks. Using spectral analysis of interbeat intervals, high-frequency heart rate variability will be extracted to quantify RSA within frequency bandwidths associated with respiration (24-1.04 for children) and log-transformed. Change in children's resting Respiratory Sinus Arrhythmia during the neutral task will be assessed from baseline to post-intervention (3 months). Higher resting RSA is expected post-intervention.

  16. Change in child Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention [ Time Frame: At completion of intervention, approximately 3 months ]
    Electrocardiogram data will be collected during a 2 minute baseline neutral video task and a 5 minute parent-child puzzle teaching task. ECG signals will be synchronized at acquisition with video and processed offline using Mindware software; research assistants will visually inspect for missing or erroneously identified R-peaks. Using spectral analysis of interbeat intervals, high-frequency heart rate variability will be extracted to quantify RSA within frequency bandwidths associated with respiration (24-1.04 for children) and log-transformed. Change in children's Respiratory Sinus Arrhythmia reactivity during the puzzle task from baseline to post-intervention will be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only biological mothers are eligible to participate due to concerns about heritability of physiological outcomes. Children of all sexes are eligible.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrollment status in one of the following services: Supplemental Nutrition Assistance Program (SNAP), Family Independence Temporary Assistance Program (FITAP), Medicaid, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), or Head Start
  • Maternal age of at least 18 years
  • Mother is primary caregiver of child
  • Mother speaks English
  • Child age is between 3-5 years
  • Family resides within 8 parish New Orleans metro area

Exclusion Criteria:

  • Mother is not biological mother
  • Diagnosis of a heart condition in the mother or the child
  • Presence of a pacemaker in the mother or the child
  • Child diagnosis of autism or global developmental delay
  • Active maternal substance use
  • Active maternal psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05129397


Contacts
Layout table for location contacts
Contact: Sarah AO Gray, PhD 337-852-4889 sgray4@tulane.edu
Contact: Anna R Wilson, B.A. 704-661-8878 awilson10@tulane.edu

Locations
Layout table for location information
United States, Louisiana
Tulane Child and Family Lab Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Sarah A.O. Gray, PhD    504-862-3318    sgray4@gmail.com   
Contact: Anna R Wilson, B.S.    504-206-2910    awilson10@tulane.edu   
Sponsors and Collaborators
Tulane University
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Sarah A Gray, PhD Tulane University
Publications:
Achenbach, T. M., & Rescorla, L. A. (2000). Manual for the ASEBA preschool forms & profiles: An integrated system of multi-informant assessment. University of Vermont.
Abidin, Richard R. Parenting stress index-short form. Charlottesville, VA: Pediatric psychology press, 1990.
Zimet, G. D., Dahlem, N. W., Zimet, S. G., & Farely, G. K. (1988). The Multidimensional Scale of perceived Social Support. Journal of Personality Assessment, 52(1), 30-41.
Zeanah, C. H. (2007). Constructing a relationship formulation for mother and child: Clinical application of the Working Model of the Child Interview. In D. Oppenheim & D. F. Goldsmith (Eds.), Attachment Theory in Clinical Work with Children: Bridging the Gap Between Research and Practice (pp. 3-30). New York, NY: Guilford Press.
Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26(1), 41-54
Smith-Donald, R., Raver, C. C., Hayes, T., & Richardson, B. (2007). Preliminary construct and concurrent validity of the Preschool Self-regulation Assessment (PSRA) for field-based research. Early Childhood Research Quarterly, 22(2), 173-187

Layout table for additonal information
Responsible Party: Sarah Gray, Associate Professor of Psychology, Clinical Professor of Psychiatry & Behavioral Sciences, Principal Investigator, Tulane University
ClinicalTrials.gov Identifier: NCT05129397    
Other Study ID Numbers: 2018-2012-TU Uptown
K23MH119047 ( U.S. NIH Grant/Contract )
First Posted: November 22, 2021    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Gray, Tulane University:
biobehavioral regulation
Respiratory Sinus Arrhythmia
parenting behavior