Mom Power With High-Adversity Mothers and Children

NCT04241913 | Withdrawn DMC

• 2 other identifiers: 2018-20121K23MH119047-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate whether the intervention, Mom Power, improves the self-regulation of mothers with a history of trauma and their children. The central hypothesis is that the intervention will shift behavioral and physiological self-regulation in mothers, children, and dyads to mitigate psychopathology risk.

Conditions

Self-regulation; Respiratory Sinus Arrhythmia

Keywords

biobehavioral self-regulation; psychopathology; parenting behavior

Outcome Measures

Primary Outcomes (2)

• Child RSA

  Child self-regulation will be assessed physiologically with RSA baseline and RSA change during a parent-child dyadic task (Skowron et al., 2013); derived from electrocardiogram (ECG) collected using Mindware Technologies ambulatory mobile recorders during 1) 2-minute resting baseline; 2) a dyadic interaction 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 (.15-.40 for mothers; .24-1.04 for children), processed in 1-minute epochs averaged across tasks, and log-transformed.

  Within 6 weeks of treatment group completion; approximately 4 months

• Parent RSA

  Parent self-regulation will be assessed physiologically with RSA baseline and RSA change during a parent-child dyadic task (Skowron et al., 2013); derived from electrocardiogram (ECG) collected using Mindware Technologies ambulatory mobile recorders during 1) 2-minute resting baseline; 2) a dyadic interaction 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 (.15-.40 for mothers; .24-1.04 for children), processed in 1-minute epochs averaged across tasks, and log-transformed.

  Within 6 weeks of treatment group completion; approximately 4 months

Secondary Outcomes (12)

• Child Behavior - parent report

  Within 6 weeks of treatment group completion; approximately 4 months

• Child Behavior - teacher report

  Within 6 weeks of treatment group completion; approximately 4 months

• Dyadic synchrony - physiological

  Within 6 weeks of treatment group completion; approximately 4 months

• Dyadic synchrony - observational

  Within 6 weeks of treatment group completion; approximately 4 months

• Parent psychopathology

  Within 6 weeks of treatment group completion; approximately 4 months

Other Outcomes (2)

• Maternal social support

  Within 6 weeks of treatment group completion; approximately 4 months

• Perceived stress

  Within 6 weeks of treatment group completion; approximately 4 months

Study Arms (2)

Treatment

EXPERIMENTAL

The treatment group receives the 10-week, group-based Mom Power intervention; intervention is provided to both mothers and children by trained providers. Treatment delivery will be consistent with the Mom Power manual.

Behavioral: Mom Power Intervention

Waitlist control

NO INTERVENTION

Participants randomized to waitlist control will not receive treatment during the experimental period; they will be offered treatment following completion of post- assessments.

Interventions

Mom Power Intervention BEHAVIORAL

Mom Power is a 10-week therapeutic intervention for at-risk families that incorporates elements of several evidence based practices. It combines didactic material with mindbody self-care skills and in vivo practice to improve the quality of attachment between parent and child, and to reduce the psychopathology of at-risk parents. The child team component provides each child with one-on-one care focusing on meeting the child's social-emotional needs and providing attachment-related experiences within a developmental framework.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Child participants can be male or female. Recruited parent must be biological mother due to interest in intergenerational patterns and concerns about heritability of the primary outcome.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• For moms: Mothers must be female, the biological mother, have an ACE score of 3 or more, speak English, and be 18 years or older.
• For children: Children must be between the ages of 2 and 5.
• For mothers: No pacemaker or self-reported heart condition; no active maternal substance abuse or psychosis on screeners (Brown \& Rounds, 1995; Degenhardt, Hall, Korten, \& Jablensky, 2005).
• For children: No parent report of diagnosis of autism or global development delay, no parent report of pacemaker or heart condition

Sponsors & Collaborators

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

Study Sites (2)

Educare New Orleans

New Orleans, Louisiana, 70122, United States

Location

Kingsley House Early Head Start Preschool

New Orleans, Louisiana, 70130, United States

Location

Related Publications (1)

• 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

Related Links

• Bibliography of Sarah Gray, PhD

MeSH Terms

Conditions

Self-Control; Arrhythmia, Sinus

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; 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: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant 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 wait list control group. Treatment delivery will be consistent with the Mom Power manual. The waitlist control group will be offered to participate in the intervention following the trial period.

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 27, 2020
• Study Start: June 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)