CARE Mentalizing-Focused Parenting Group Outcomes Study

Parenting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580459
• Other study ID #: 2020-11240
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: May 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Parent-Child Relationship
• Parenting

Intervention

Behavioral:
• CARE Parenting Group Treatment
The CARE parenting group treatment is a 12-session, 60-minute group mentalizing-focused intervention with 3 monthly parent-child sessions.
• Treatment as Usual (TAU)
Treatment as usual (TAU) involves typical child outpatient mental health services, such as individual child appointments and medication management.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	The FAR Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in parental reflective functioning	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.	Baseline to post-intervention (12 weeks)
Primary	Change in parenting stress	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.	Baseline to post-intervention (12 weeks)
Secondary	Change in parent psychiatric distress	Change in parent/caregiver psychiatric distress as measured by parent/caregiver report on the Brief Symptom Inventory. Responses are reported on a 5-point Likert scale from 0 to 4. Global severity index scores for the Brief Symptom Inventory (BSI-18) range from 0 to 82, with lower scores indicating better outcomes.	Baseline to post-intervention (12 weeks)
Secondary	Change in child social-emotional impairment	Change in children's social-emotional impairment as measured by parent/caregiver and child report on the Youth Outcome Questionnaire. Responses are reported on a 5-point Likert scale from 0 to 4. Total scores on the Youth Outcomes Questionnaire (Y-OQ-30.2) range from 0 to 120, with lower scores indicating better outcomes.	Baseline to post-intervention (12 weeks)
Secondary	Change in family functioning	Change in family functioning as measured by parent/caregiver and child report on the Family Assessment Device. Responses are reported on a 4-point Likert scale from 1 to 4. Total scores on the General Functioning scale of the Family Assessment Device range from 12 to 48, with lower scores indicating better outcomes.	Baseline to post-intervention (12 weeks)
Secondary	Change in parent emotion regulation	Change in parent/caregiver emotion regulation as measured by parent/caregiver report on the Difficulties with Emotion Regulation Scale. Responses are reported on a 5-point Likert scale from 1 to 5. Total scores for the Difficulties with Emotion Regulation Scale (DERS-18) range from 18 to 90, with lower scores indicating better outcomes.	Baseline to post-intervention (12 weeks)
Secondary	Change in parent perceptions of social support	Change in parent/caregiver perceptions of social support as measured by parent/caregiver report on the Interpersonal Support Evaluation List. Responses are reported on a 4-point Likert scale from 0 to 3. Total scores on the Interpersonal Support Evaluation List (ISEL-12) range from 0 to 36, with higher scores indicating better outcomes.	Baseline to post-intervention (12 weeks)
Secondary	Change in parent perceptions of belongingness	Change in parent/caregiver perceptions of belongingness as measured by parent/caregiver report on the Sense of Belongingness Inventory. Responses are reported on a 4-point Likert scale from 1 to 4. Total scores for the Psychological Experience scale of the Sense of Belongingness Inventory range from 18 to 72, with higher scores indicating better outcomes.	Baseline to post-intervention (12 weeks)
Secondary	Change in parent-child relationship	Change in parent-child relationship as measured by child report on the Security Scale. Responses are reported on a 4-point Likert scale from 1 to 4. Total scores on the Security Scale range from 1 to 96, with higher scores indicating better outcomes.	Baseline to post-intervention (12 weeks)
Secondary	Change in reported exposure to adverse childhood experiences (ACEs)	Change in reported parent and child exposure to ACEs as measured by parent/caregiver report on the Adverse Childhood Experiences (ACE) questionnaire. Responses are reported on a binary (yes/no) scale. Total scores on the Adverse Childhood Experiences questionnaire range from 0 to 10.	Baseline and post-intervention (12 weeks)
Secondary	Change in parent experiences of racism and discrimination	Change in reported distress in relation to experiences of racism and/or discrimination as measured by parent/caregiver report on the Daily Life Experiences scale of the Racism and Life Experience Scales. Responses are reported on two 6-point Likert scales from 0 to 5. Total scores on the Daily Life Experiences scale of the Racism and Life Experience Scales range from 0 to 100, with lower scores indicating better outcomes.	Baseline and post-intervention (12 weeks)