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.
Brief Title
CARE Mentalizing-Focused Parenting Group Outcomes Study
Categories
Completion Date
Completion Date Type
Actual
Conditions
Parent-Child Relationship
Parenting
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
* 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
Inclusion Criteria
Inclusion Criteria:
* Parents/caregivers of child receiving mental health services at community child outpatient clinic
* English- or Spanish-speaking
* Parents/caregivers of child receiving mental health services at community child outpatient clinic
* English- or Spanish-speaking
Gender
All
Gender Based
false
Keywords
Attachment
Parenting
Parent-Child Relationship
Caregivers
Parents
Child Mental Health
Child Development
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
12 Years
NCT Id
NCT04580459
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2020-11240
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Connecting and Reflecting Experience (CARE) Mentalizing-Focused Parenting Group Treatment Outcomes Study
Primary Outcomes
Outcome Description
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.
Outcome Measure
Change in parental reflective functioning
Outcome Time Frame
Baseline to post-intervention (12 weeks)
Outcome Description
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.
Outcome Measure
Change in parenting stress
Outcome Time Frame
Baseline to post-intervention (12 weeks)
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Baseline to post-intervention (12 weeks)
Outcome Measure
Change in parent psychiatric distress
Outcome Description
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.
Outcome Time Frame
Baseline to post-intervention (12 weeks)
Outcome Measure
Change in child social-emotional impairment
Outcome Description
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.
Outcome Time Frame
Baseline to post-intervention (12 weeks)
Outcome Measure
Change in family functioning
Outcome Description
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.
Outcome Time Frame
Baseline to post-intervention (12 weeks)
Outcome Measure
Change in parent emotion regulation
Outcome Description
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.
Outcome Time Frame
Baseline to post-intervention (12 weeks)
Outcome Measure
Change in parent perceptions of social support
Outcome Description
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.
Outcome Time Frame
Baseline to post-intervention (12 weeks)
Outcome Measure
Change in parent perceptions of belongingness
Outcome Description
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.
Outcome Time Frame
Baseline to post-intervention (12 weeks)
Outcome Measure
Change in parent-child relationship
Outcome Description
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.
Outcome Time Frame
Baseline and post-intervention (12 weeks)
Outcome Measure
Change in reported exposure to adverse childhood experiences (ACEs)
Outcome Description
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.
Outcome Time Frame
Baseline and post-intervention (12 weeks)
Outcome Measure
Change in parent experiences of racism and discrimination
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Amanda Zayde
Investigator Email
azayde@montefiore.org