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Clinical Trials/NCT04580459
NCT04580459
Completed
Not Applicable

Connecting and Reflecting Experience (CARE) Mentalizing-Focused Parenting Group Treatment Outcomes Study

Montefiore Medical Center1 site in 1 country78 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parent-Child Relationship
Sponsor
Montefiore Medical Center
Enrollment
78
Locations
1
Primary Endpoint
Change in parenting stress
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The primary objective of this clinical trial is to evaluate the 12-week mentalizing-focused group parenting intervention, Connecting and Reflecting Experience (CARE), relative to a treatment as usual (TAU) group in an outpatient child mental health clinic.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
August 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Parents/caregivers of child receiving mental health services at community child outpatient clinic
  • English- or Spanish-speaking

Exclusion Criteria

  • Parent has severe mental illness or significant cognitive impairment
  • Child has significant developmental delay

Outcomes

Primary Outcomes

Change in parenting stress

Time Frame: Baseline to post-intervention (12 weeks)

Change in parenting stress as measured by parent/caregiver report on the Parenting Stress Index. Responses are reported on a 5-point Likert scale from 1 to 5. Total scores for the Parenting Stress Index (PSI-SF-4) range from 36 to 180, with lower scores indicating better outcomes.

Change in parental reflective functioning

Time Frame: Baseline to post-intervention (12 weeks)

Change in parental reflective functioning as measured by parent/caregiver report on the Parental Reflective Functioning Questionnaire. Responses are reported on a 7-point Likert scale from 1 to 7. Total scores for the three sub-scales (Pre-Mentalizing Modes, Certainty about Mental States, and Interest and Curiosity) range from 6 to 42. Lower scores on Pre-Mentalizing Modes, moderate scores on Certainty about Mental States, and higher scores on Interest and Curiosity indicate better outcomes.

Secondary Outcomes

  • Change in parent psychiatric distress(Baseline to post-intervention (12 weeks))
  • Change in child social-emotional impairment(Baseline to post-intervention (12 weeks))
  • Change in parent-child relationship(Baseline to post-intervention (12 weeks))
  • Change in reported exposure to adverse childhood experiences (ACEs)(Baseline and post-intervention (12 weeks))
  • Change in family functioning(Baseline to post-intervention (12 weeks))
  • Change in parent emotion regulation(Baseline to post-intervention (12 weeks))
  • Change in parent experiences of racism and discrimination(Baseline and post-intervention (12 weeks))
  • Change in parent perceptions of social support(Baseline to post-intervention (12 weeks))
  • Change in parent perceptions of belongingness(Baseline to post-intervention (12 weeks))

Study Sites (1)

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