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

NCT05129397 | Completed DMC

• 2 other identifiers: 2018-2012-TU UptownK23MH119047
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psychopathology

Keywords

biobehavioral regulation; Respiratory Sinus Arrhythmia; parenting behavior

Outcome Measures

Primary Outcomes (6)

• Change from baseline maternal depressive symptoms at post-intervention

  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.

  At completion of intervention, approximately 3 months

• Change from baseline maternal depressive symptoms at 6 month 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.

  6 months (follow up)

• Change from baseline maternal posttraumatic stress symptoms at post-intervention

  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.

  At completion of intervention, approximately 3 months

• Change from baseline maternal posttraumatic stress symptoms at 6 month 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.

  6 months (follow up)

• Change from baseline child behavior at post-intervention

  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.

  At completion of intervention, approximately 3 months

• Change from baseline child behavior at 6 month 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.

  6 months (follow up)

Secondary Outcomes (16)

• Change in parenting stress from baseline to post-intervention

  At completion of intervention, approximately 3 months

• Change in parenting stress from baseline to 6 month follow up

  6 months

• Change in self-report parent child relationship from baseline to post intervention

  At completion of intervention, approximately 3 months

• Change in self-report parent child relationship from baseline to follow up

  6 months

• Change in maternal social support from baseline to post intervention

  At completion of intervention, approximately 3 months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Informational control

ACTIVE COMPARATOR

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

Interventions

Mom Power BEHAVIORAL

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.

Treatment

Mom Power Informational Mailing BEHAVIORAL

This active comparison condition intervention includes two individual sessions along with 10 weeks of informational mailing with content related to Mom Power core concepts.

Informational control

Eligibility Criteria

• Age: 3 Years+
• Gender Eligibility Details: Only biological mothers are eligible to participate due to concerns about heritability of physiological outcomes. Children of all sexes are eligible.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Tulane Child and Family Lab

New Orleans, Louisiana, 70118, United States

Location

Related Publications (13)

• Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006.

  PMID: 15550799 BACKGROUND

• Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.

  PMID: 26606250 BACKGROUND

• Achenbach, T. M., & Rescorla, L. A. (2000). Manual for the ASEBA preschool forms & profiles: An integrated system of multi-informant assessment. University of Vermont.

  BACKGROUND

• Abidin, Richard R. Parenting stress index-short form. Charlottesville, VA: Pediatric psychology press, 1990.

  BACKGROUND

• Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.

  PMID: 2280326 BACKGROUND

• Feldman R, Granat A, Pariente C, Kanety H, Kuint J, Gilboa-Schechtman E. Maternal depression and anxiety across the postpartum year and infant social engagement, fear regulation, and stress reactivity. J Am Acad Child Adolesc Psychiatry. 2009 Sep;48(9):919-927. doi: 10.1097/CHI.0b013e3181b21651.

  PMID: 19625979 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• Rodriguez VJ, Shaffer A. Validation of the Regulating Emotions in Parenting Scale (REPS): Factor structure and measurement invariance. J Fam Psychol. 2021 Jun;35(4):468-477. doi: 10.1037/fam0000808. Epub 2020 Sep 17.

  PMID: 32940490 BACKGROUND

• Conduct Problems Prevention Research Group. Initial impact of the Fast Track prevention trial for conduct problems: I. The high-risk sample. Conduct Problems Prevention Research Group. J Consult Clin Psychol. 1999 Oct;67(5):631-47.

  PMID: 10535230 BACKGROUND

• 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

  BACKGROUND

• Rosenblum KL, Muzik M, Morelen DM, Alfafara EA, Miller NM, Waddell RM, Schuster MM, Ribaudo J. A community-based randomized controlled trial of Mom Power parenting intervention for mothers with interpersonal trauma histories and their young children. Arch Womens Ment Health. 2017 Oct;20(5):673-686. doi: 10.1007/s00737-017-0734-9. Epub 2017 Jun 25.

  PMID: 28647759 BACKGROUND

• Rosenblum K, Lawler J, Alfafara E, Miller N, Schuster M, Muzik M. Improving Maternal Representations in High-Risk Mothers: A Randomized, Controlled Trial of the Mom Power Parenting Intervention. Child Psychiatry Hum Dev. 2018 Jun;49(3):372-384. doi: 10.1007/s10578-017-0757-5.

  PMID: 28936602 BACKGROUND

MeSH Terms

Conditions

Arrhythmia, Sinus

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah A Gray, PhD

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology, Clinical Professor of Psychiatry & Behavioral Sciences, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 22, 2021
• Study Start: November 1, 2021
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)