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

Psychopathology Clinical Trial

Official title:

A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05129397
• Other study ID #: 2018-2012-TU Uptown
• Secondary ID: K23MH119047
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: May 30, 2026

Study information

• Verified date: March 2024
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychopathology

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Tulane Child and Family Lab	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (13)

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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.

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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	Change in parenting stress from baseline to post-intervention	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.	At completion of intervention, approximately 3 months
Secondary	Change in parenting stress from baseline to 6 month follow up	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.	6 months
Secondary	Change in self-report parent child relationship from baseline to post intervention	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.	At completion of intervention, approximately 3 months
Secondary	Change in self-report parent child relationship from baseline to follow up	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.	6 months
Secondary	Change in maternal social support from baseline to post intervention	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.	At completion of intervention, approximately 3 months
Secondary	Change in maternal social support from baseline to follow up	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.	6 months
Secondary	Change in observed parenting sensitivity from baseline to post-intervention	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.	At completion of intervention, approximately 3 months
Secondary	Change in Working Models from baseline to post-intervention	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.	At completion of intervention, approximately 3 months
Secondary	Change in maternal emotion regulation from baseline to post-intervention	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.	At completion of intervention, approximately 3 months
Secondary	Change in maternal emotion regulation from baseline to follow up	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.	6 months
Secondary	Change in maternal emotion regulation while parenting from baseline to post intervention	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.	At completion of intervention, approximately 3 months
Secondary	Change in maternal emotion regulation while parenting from baseline to follow up	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.	6 months
Secondary	Change in maternal resting Respiratory Sinus Arrhythmia from baseline to post-intervention	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.	At completion of intervention, approximately 3 months
Secondary	Change in maternal Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention	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)	At completion of intervention, approximately 3 months
Secondary	Change in child resting Respiratory Sinus Arrhythmia from baseline to post-intervention	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.	At completion of intervention, approximately 3 months
Secondary	Change in child Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention	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.	At completion of intervention, approximately 3 months