Mom Power With High-Adversity Mothers and Children

Self-regulation Clinical Trial

— MPHAMC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04241913
• Other study ID #: 2018-2012
• Secondary ID: 1K23MH119047-01
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2021
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Adverse childhood experiences (ACEs) are significant risk factors for psychopathology across the lifespan - risks that extend to the next generation, likely transmitted through both biological and behavioral pathways. Biobehavioral self-regulation and parenting are key candidates for transmission and potential points of intervention. However, nearly all intervention research takes a one-generation approach, measuring outcomes in the individual adult or child in treatment. Additionally, very little research has examined biomarkers of self-regulation in parents or children following treatment, and no known research has examined these processes in parents and young children simultaneously across treatment to explore bidirectional effects. There is a critical need to specify targets of two-generation interventions among high-adversity families to decrease intergenerational transmission of mental illness. The objective of this RCT is to determine whether Mom Power, an evidence-based two generation intervention for mothers with histories of trauma, enhances physiological and behavioral self-regulation in mothers and young children, testing mechanisms and examining bidirectional effects. The central hypothesis is that the intervention will shift behavioral and physiological (Respiratory Sinus Arrhythmia) self-regulation in mothers, children, and dyads to mitigate psychopathology risk. Three specific aims are proposed: 1) Examine intervention effects on children's biobehavioral self-regulation and psychopathology; 2) Examine intervention effects on mothers' biobehavioral self-regulation, psychopathology, and parenting behavior; and 3) Examine intergenerational change processes, including shifts in dyadic physiological and behavioral synchrony as well as bidirectional influences between mother and child self-regulation.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Participants in this study must include a mother-child dyad. There is inclusion and exclusion criteria for both mother and child.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arrhythmia, Sinus
• Respiratory Sinus Arrhythmia
• Self-regulation

Intervention

Behavioral:
• Mom Power Intervention
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.

Locations

Country	Name	City	State
United States	Educare New Orleans	New Orleans	Louisiana
United States	Kingsley House Early Head Start Preschool	New Orleans	Louisiana

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal social support	Mothers will report on social support (Multidimensional Scale of Perceived Social Support); range: 12-84; higher scores reflect higher perceived support.	Within 6 weeks of treatment group completion; approximately 4 months
Other	Perceived stress	Mothers will report on perceived stress (Perceived Stress Scale-4); range: 0-16; higher scores reflect higher stress	Within 6 weeks of treatment group completion; approximately 4 months
Primary	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
Primary	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	Child Behavior - parent report	Child Behavior problems will be assessed via Total Score on parent report with the Child Behavior Checklist; higher scores indicate higher behavior problems (T score is a standardized score with a mean of 50).	Within 6 weeks of treatment group completion; approximately 4 months
Secondary	Child Behavior - teacher report	Child Behavior problems will be assessed via teacher report with the Teacher Report Form; Achenbach & Rescorla, 2000. Higher scores indicate higher behavior problems (T score is a standardized score with a mean of 50).	Within 6 weeks of treatment group completion; approximately 4 months
Secondary	Dyadic synchrony - physiological	Dyadic synchrony will be assessed using EKG (derived from maternal and child RSA, as described above)	Within 6 weeks of treatment group completion; approximately 4 months
Secondary	Dyadic synchrony - observational	Dyadic synchrony will be assessed observationally with the Coding Interactive Behavior (CIB) measure.	Within 6 weeks of treatment group completion; approximately 4 months
Secondary	Parent psychopathology	Parents will report on their own depression symptoms (Patient Health Questionnaire-9 and Posttraumatic Checklist - 5); individual scales will be z-scored and summed, with higher values reflecting higher levels of psychopathology	Within 6 weeks of treatment group completion; approximately 4 months
Secondary	Parent emotion regulation	Parents will report on their own emotion regulation using the difficulties in emotion regulation (DERS; range: 36-180); higher scores reflect more difficulties with emotion regulation.	Within 6 weeks of treatment group completion; approximately 4 months
Secondary	Sensitive parenting behavior	Observational data derived from parent-child interactions will be examined, coding using the Coding Interactive Behavior measure (CIB). Higher scores reflect more sensitivity.	Within 6 weeks of treatment group completion; approximately 4 months
Secondary	Parent self-efficacy	Parents will report on their own parenting efficacy using the Parent Sense of Competence scale; range: 17-102, higher scores reflect more self-efficacy	Within 6 weeks of treatment group completion; approximately 4 months
Secondary	Parenting behavior	Parents will report on their own parenting behavior using the Conflict Tactic Scales - Parent Child (CTS-PC); range: 0-240, higher values reflect harsher parenting	Within 6 weeks of treatment group completion; approximately 4 months
Secondary	Parent mental representation	Parents will complete an abbreviated version of the Working Model of the Child Interview; interviews will be coded into 3 categories, and it is hypothesized that proportion of "balanced" representations will be higher post-treatment.	Within 6 weeks of treatment group completion; approximately 4 months
Secondary	Child Behavioral Self-Regulation, observational	Child self-regulation will be assessed behaviorally using observation (Preschool Self-Regulation Assessment); children's behavior will be observed during 6 tasks, and codes z-scored and summed; higher scores reflect higher effortful control/executive function	Within 6 weeks of treatment group completion; approximately 4 months
Secondary	Child Behavioral Self-Regulation, parent report	Child self-regulation will also be assessed by parent-report (Social Competence Scale - Emotion Regulation); range: 0-48; higher scores reflect higher self-regulation	Within 6 weeks of treatment group completion; approximately 4 months

External Links

•   Bibliography of Sarah Gray, PhD