Parent-Child Relationship, Parenting
Conditions
Keywords
Attachment, Parenting, Parent-Child Relationship, Caregivers, Parents, Child Mental Health, Child Development
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.
Interventions
BEHAVIORALCARE Parenting Group Treatment
The CARE parenting group treatment is a 12-session, 60-minute group mentalizing-focused intervention with 3 monthly parent-child sessions.
BEHAVIORALTreatment as Usual (TAU)
Treatment as usual (TAU) involves typical child outpatient mental health services, such as individual child appointments and medication management.
Sponsors
The FAR Fund
Montefiore Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in parental reflective functioning | 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. |
| Change in parenting stress | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in family functioning | Baseline to post-intervention (12 weeks) | 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. |
| Change in parent emotion regulation | Baseline to post-intervention (12 weeks) | 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. |
| Change in parent perceptions of social support | Baseline to post-intervention (12 weeks) | 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. |
| Change in parent psychiatric distress | Baseline to post-intervention (12 weeks) | 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. |
| Change in parent-child relationship | Baseline to post-intervention (12 weeks) | 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. |
| Change in reported exposure to adverse childhood experiences (ACEs) | Baseline and post-intervention (12 weeks) | 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. |
| Change in parent experiences of racism and discrimination | Baseline and post-intervention (12 weeks) | 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. |
| Change in parent perceptions of belongingness | Baseline to post-intervention (12 weeks) | 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. |
| Change in child social-emotional impairment | Baseline to post-intervention (12 weeks) | 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. |
Countries
United States
Outcome results
None listed