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Clinical Trials/NCT04580459
NCT04580459CompletedNot Applicable

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

Montefiore Medical Center2 sites in 1 country78 target enrollmentStarted: October 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
78
Locations
2
Primary Endpoint
Change in parenting stress

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
12 Years to 99 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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