Self-regulation Clinical Trial
— MPHAMCOfficial title:
A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children
Verified date | June 2021 |
Source | Tulane University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
United States | Educare New Orleans | New Orleans | Louisiana |
United States | Kingsley House Early Head Start Preschool | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Tulane University | National Institute of Mental Health (NIMH), National Institutes of Health (NIH) |
United States,
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
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 |
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