CARE Mentalizing-Focused Parenting Group Outcomes Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Parenting, Parent-Child Relationship

Intervention / Treatment
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* Behavioral: CARE Parenting Group Treatment
* Behavioral: Treatment as Usual (TAU)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARE Parenting Group Treatment<br>Participants receive the CARE mentalizing-focused group parenting intervention. | Behavioral: CARE Parenting Group Treatment<br>* The CARE parenting group treatment is a 12-session, 60-minute group mentalizing-focused intervention with 3 monthly parent-child sessions.<br>|
| Other: Treatment as Usual (TAU)<br>Participants continue to receive treatment as usual in the outpatient child mental health clinic. | Behavioral: Treatment as Usual (TAU)<br>* Treatment as usual (TAU) involves typical child outpatient mental health services, such as individual child appointments and medication management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attachment, Parenting, Parent-Child Relationship, Caregivers, Parents, Child Mental Health, Child Development