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Completed

NCT Number: NCT04580459

CARE Mentalizing-Focused Parenting Group Outcomes Study

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.

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Key information

Age range

12 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10470, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CARE Parenting Group Treatment

Behavioral

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)

Behavioral

Treatment as usual (TAU) involves typical child outpatient mental health services, such as individual child appointments and medication management.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in parent psychiatric distress

    Time frame: 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.

  2. Change in child social-emotional impairment

    Time frame: 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.

  3. Change in family functioning

    Time frame: 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.

  4. Change in parent emotion regulation

    Time frame: 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.

  5. Change in parent perceptions of social support

    Time frame: 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.

  6. Change in parent perceptions of belongingness

    Time frame: 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.

  7. Change in parent-child relationship

    Time frame: 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.

  8. Change in reported exposure to adverse childhood experiences (ACEs)

    Time frame: 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.

  9. Change in parent experiences of racism and discrimination

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • The FAR Fund

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2020
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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