Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-26 @ 6:04 AM
Study NCT ID:
NCT04580459
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2020-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CARE Mentalizing-Focused Parenting Group Outcomes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-31', 'studyFirstSubmitDate': '2020-10-02', 'studyFirstSubmitQcDate': '2020-10-02', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in parental reflective functioning', 'timeFrame': 'Baseline to post-intervention (12 weeks)', '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.'}, {'measure': 'Change in parenting stress', 'timeFrame': 'Baseline to post-intervention (12 weeks)', '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.'}], 'secondaryOutcomes': [{'measure': 'Change in parent psychiatric distress', 'timeFrame': 'Baseline to post-intervention (12 weeks)', '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.'}, {'measure': 'Change in child social-emotional impairment', 'timeFrame': 'Baseline to post-intervention (12 weeks)', '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."}, {'measure': 'Change in family functioning', 'timeFrame': 'Baseline to post-intervention (12 weeks)', '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.'}, {'measure': 'Change in parent emotion regulation', 'timeFrame': 'Baseline to post-intervention (12 weeks)', '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.'}, {'measure': 'Change in parent perceptions of social support', 'timeFrame': 'Baseline to post-intervention (12 weeks)', '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.'}, {'measure': 'Change in parent perceptions of belongingness', 'timeFrame': 'Baseline to post-intervention (12 weeks)', '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.'}, {'measure': 'Change in parent-child relationship', 'timeFrame': 'Baseline to post-intervention (12 weeks)', '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.'}, {'measure': 'Change in reported exposure to adverse childhood experiences (ACEs)', 'timeFrame': 'Baseline and post-intervention (12 weeks)', '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.'}, {'measure': 'Change in parent experiences of racism and discrimination', 'timeFrame': 'Baseline and post-intervention (12 weeks)', '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Attachment', 'Parenting', 'Parent-Child Relationship', 'Caregivers', 'Parents', 'Child Mental Health', 'Child Development'], 'conditions': ['Parent-Child Relationship', 'Parenting']}, 'referencesModule': {'references': [{'pmid': '36862314', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents/caregivers of child receiving mental health services at community child outpatient clinic\n* English- or Spanish-speaking\n\nExclusion Criteria:\n\n* Parent has severe mental illness or significant cognitive impairment\n* Child has significant developmental delay'}, 'identificationModule': {'nctId': 'NCT04580459', 'briefTitle': 'CARE Mentalizing-Focused Parenting Group Outcomes Study', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Connecting and Reflecting Experience (CARE) Mentalizing-Focused Parenting Group Treatment Outcomes Study', 'orgStudyIdInfo': {'id': '2020-11240'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CARE Parenting Group Treatment', 'description': 'Participants receive the CARE mentalizing-focused group parenting intervention.', 'interventionNames': ['Behavioral: CARE Parenting Group Treatment']}, {'type': 'OTHER', 'label': 'Treatment as Usual (TAU)', 'description': 'Participants continue to receive treatment as usual in the outpatient child mental health clinic.', 'interventionNames': ['Behavioral: Treatment as Usual (TAU)']}], 'interventions': [{'name': 'CARE Parenting Group Treatment', 'type': 'BEHAVIORAL', 'description': 'The CARE parenting group treatment is a 12-session, 60-minute group mentalizing-focused intervention with 3 monthly parent-child sessions.', 'armGroupLabels': ['CARE Parenting Group Treatment']}, {'name': 'Treatment as Usual (TAU)', 'type': 'BEHAVIORAL', 'description': 'Treatment as usual (TAU) involves typical child outpatient mental health services, such as individual child appointments and medication management.', 'armGroupLabels': ['Treatment as Usual (TAU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10470', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Amanda Zayde, PsyD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'The FAR Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}