NCT04580459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

October 2, 2020

Last Update Submit

May 31, 2023

Conditions

Parent-Child RelationshipParenting

Keywords

AttachmentParentingParent-Child RelationshipCaregiversParentsChild Mental HealthChild Development

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Change in parent psychiatric distress

    Baseline to post-intervention (12 weeks)

  • Change in child social-emotional impairment

    Baseline to post-intervention (12 weeks)

  • Change in family functioning

    Baseline to post-intervention (12 weeks)

  • Change in parent emotion regulation

    Baseline to post-intervention (12 weeks)

  • Change in parent perceptions of social support

    Baseline to post-intervention (12 weeks)

  • +4 more secondary outcomes

Study Arms (2)

CARE Parenting Group Treatment

EXPERIMENTAL

Participants receive the CARE mentalizing-focused group parenting intervention.

Behavioral: CARE Parenting Group Treatment

Treatment as Usual (TAU)

OTHER

Participants continue to receive treatment as usual in the outpatient child mental health clinic.

Behavioral: Treatment as Usual (TAU)

Interventions

CARE Parenting Group TreatmentBEHAVIORAL

The CARE parenting group treatment is a 12-session, 60-minute group mentalizing-focused intervention with 3 monthly parent-child sessions.

CARE Parenting Group Treatment
Treatment as Usual (TAU)BEHAVIORAL

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

Treatment as Usual (TAU)

Eligibility Criteria

Age12 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents/caregivers of child receiving mental health services at community child outpatient clinic
  • English- or Spanish-speaking

You may not qualify if:

  • Parent has severe mental illness or significant cognitive impairment
  • Child has significant developmental delay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10470, United States

Location

Related Publications (1)

  • Zayde A, Derella OJ, Kilbride A. Safe haven in adolescence: Improving parental reflective functioning and youth attachment and mental health with the Connecting and Reflecting Experience. Infant Ment Health J. 2023 Mar;44(2):268-283. doi: 10.1002/imhj.22042. Epub 2023 Mar 2.

    PMID: 36862314DERIVED

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Amanda Zayde, PsyD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 8, 2020

Study Start

October 1, 2020

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

June 2, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)