A Male Caregiver Adaptation Study of the Connecting and Reflecting Experience Parenting Program (Male-CARE)

September 10, 2026 updated by: Montefiore Medical Center

Male caregivers play a critical role in children's emotional development, yet they are often underrepresented in parenting interventions and may experience unique barriers to emotional engagement and support. This study will evaluate whether a 12-session parenting group therapy program is feasible, acceptable, and appropriate for male-identifying caregivers of children and adolescents receiving mental health services.

The intervention being studied is the Connecting and Reflecting Experience (CARE) parenting program, a mentalizing-focused group therapy designed to strengthen caregivers' ability to reflect on their own and their child's thoughts, feelings, and behaviors. CARE has demonstrated promise in improving parental reflective functioning, reducing parenting stress, and enhancing parent-child relationships in prior studies, but has not yet been evaluated in a group composed exclusively of male-identifying caregivers.

Participants will take part in a 12-session weekly CARE group delivered via telehealth, with each session lasting one hour. Participants will also be asked to complete brief self-report surveys before, during, and after participation in the group. The purpose of the study is to inform future intervention development and determine whether CARE is a useful intervention for groups of male caregivers.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10461
        • Montefiore ACUTE Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Parents or primary caregivers who identify as male or identifies themself as having a male caregiving role (e.g., identifies as a father or "father figure")
  • Caregiver of a child aged 0-17 years
  • Child currently receiving psychiatric or behavioral health services within the Montefiore-Einstein Health System
  • English-speaking
  • Insurance accepted by Montefiore outpatient behavioral health services

Exclusion Criteria:

  • Prior participation in a Connecting and Reflecting Experience (CARE) group
  • Participation in another parenting-focused group or workshop within the past year
  • Current episode of psychosis or mania, or active suicidal ideation requiring a higher level of care
  • Serious psychiatric, neurocognitive, or substance-related difficulties requiring inpatient treatment or that would impede group participation, as determined by the PI or study clinician
  • Limited English fluency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Connecting and Reflecting Experience (CARE) Program
Participants will enroll in a 12-session CARE parenting group therapy.
Behavioral: Connecting and Reflecting Experience (CARE) Program
The intervention consists of weekly one-hour mentalizing-focused parenting group sessions with up to seven male-identifying caregivers per group and one to two trained facilitators. CARE is a therapy focused on parents' reflective capacity, or the ability to consider how our own and our children's thoughts, feelings, intentions, and other mental states shape behavior and parent-child relationships.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline to Post-Treatment in Parenting Stress
Time Frame: The PSI-SF will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).
Change in parenting stress from baseline will be measured using the total score on a self-reported questionnaire: the 36-item Parenting Stress Index, Short-Form (PSI-SF; Abidin, 2012). Item responses are rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Scores are summed to generate a total score ranging from 36 to 180. Raw scores can be converted to percentile based on a normed sample. Higher raw and percentile scores indicate higher levels of parenting stress. Scores falling between the 16th and 84th percentiles are considered within the normal range of parenting stress, scores between the 85th and 89th percentiles are considered high, and scores at the 90th percentile and above are considered in the clinically significant range.
The PSI-SF will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).
Change from Baseline to Post-Treatment in Parental Reflective Functioning
Time Frame: The PRFQ will be administered at baseline (approximately 0-2 weeks pre-intervention) and at post-intervention (after completion of Session 12, approximately 15 weeks after baseline measurement).
Change in parental reflective functioning from baseline will be measured using the 18-item Parental Reflective Functioning Questionnaire (PRFQ; Luyten et al., 2017). This measure assesses three dimensions of reflective functioning: Prementalizing Modes, Certainty about Mental States, and Interest and Curiosity about Mental States. Scores are measured using a 7-point Likert scale ranging from 1 (Strongly Disagree) to 7 (Strongly Agree) across three subscales, with higher scores indicating higher levels of that specific dimension. Subscale scores are calculated and reported as mean scores (range 6 to 42). Although clinical thresholds have not been established, adaptive reflective functioning is characterized by low Prementalizing Modes, mid-range Certainty about Mental States, and high Interest and Curiosity about Mental States.
The PRFQ will be administered at baseline (approximately 0-2 weeks pre-intervention) and at post-intervention (after completion of Session 12, approximately 15 weeks after baseline measurement).
Change from Baseline to Post-Treatment in Restrictive Emotionality
Time Frame: The Restrictive Emotionality Subscale of the MRNI-R will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement)
Change in restrictive emotionality from baseline will be measured using a subscale on a self-reported questionnaire: the Restrictive Emotionality subscale of the Male Role Norms Inventory-Revised (MRNI-R; Levant et al., 2007). The subscale consists of 8 items rated on a 7-point Likert-type scale ranging from 1 (Strongly Disagree) to 7 (Strongly Agree). A mean subscale score is calculated, with possible scores ranging from 8 to 56. Though threshold scores have not been established for the MRNI-R, higher subscale scores indicate greater endorsement of restrictive emotionality norms, reflecting beliefs emphasizing emotional control and limited emotional expression, whereas lower subscale scores indicate greater emotional openness and comfort with emotional expression.
The Restrictive Emotionality Subscale of the MRNI-R will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement)
Change from First Session to Post-Treatment in Therapeutic Group Processes
Time Frame: The TFI-19 will be administered after participants attend their first group session (approximately 0-2 weeks after baseline measurement) and again at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).
Changes in therapeutic group processes from after the first group session attended to post-intervention will be assessed using subscales from a self-report questionnaire, the revised Therapeutic Factors Inventory-19 (TFI-19; Joyce et al., 2011). Items are rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Subscale scores are calculated as the mean of item ratings (mean score range: 1-7), with higher scores indicating stronger perceptions of the corresponding therapeutic factors within the CARE group. The four subscales include Instillation of Hope (4 items; score range: 4-28), Secure Emotional Expression (7 items; score range: 7-49), Awareness of Relational Impact (5 items; score range: 5-35), and Social Learning (3 items; score range: 3-21).
The TFI-19 will be administered after participants attend their first group session (approximately 0-2 weeks after baseline measurement) and again at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).
Post-Treatment Ratings of Feasibility
Time Frame: This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Intervention feasibility will be measured by Feasibility of Intervention Measure (FIM; Weiner et al., 2017). The FIM is a 4-item subscale that measures the extent to which a new treatment or innovation can be successfully used or carried out by the caregiver in this setting. All items are scored on a 5-point Likert scale, from 1 (Completely disagree) to 5 (Completely agree). Higher scores correlate with greater feasibility of the implementation of the intervention.
This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Post-Treatment Ratings of Acceptability
Time Frame: This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Intervention acceptability will be measured by Acceptability of Intervention Measure (AIM; Weiner et al., 2017). The AIM is a 4-item subscale that measures the extent to which a new treatment or innovation is found to be acceptable by the caregiver within this setting. All items are scored on a 5-point Likert scale, from 1 (Completely disagree) to 5 (Completely agree). Higher scores correlate with greater acceptability of the intervention.
This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Post-Treatment Ratings of Appropriateness
Time Frame: This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Intervention appropriateness will be measured by Intervention Appropriateness Measure (IAM; Weiner et al., 2017). The IAM is a 4-item subscale that measures the extent to which a new treatment or innovation is deemed to be appropriate by the caregiver within this setting. All items are scored on a 5-point Likert scale, from 1 (Completely disagree) to 5 (Completely agree). Higher scores correlate with greater appropriateness of the intervention.
This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Post-Treatment Participant Group Attendance
Time Frame: Time Frame: This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Participant attendance will be tracked, and the average number of group sessions completed by participants at the end of the intervention will be summarized using the mean number of sessions attended.
Time Frame: This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Post-Treatment Ratings of Outcomes and Feedback
Time Frame: This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Participants will complete a post-intervention feedback survey. Quantitative items include six 10-point Likert scale questions assessing caregivers' comfort with emotional expression in group, overall satisfaction, perceived helpfulness for caregivers' emotional well-being, perceived helpfulness for the caregiver-child relationship, perceived emotional challenge of participating in the group, and challenge attending sessions (min score = 1, not at all; max score = 10, extremely). Higher scores indicate greater improvement or acceptability, with the exception of items related to perceived challenge for which higher scores indicate lower feasibility and acceptability. Caregivers also rate change in comfort in expressing emotions relative to the start of the group on a 5-point Likert scale (min score = 1, much less comfortable; max score = 5, much more comfortable). Participants indicate whether they would recommend CARE to other male caregivers using a 2-point scale (1 = Yes, 0 = No).
This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Amanda Zayde, Psy.D., Montefiore Medical Center/Albert Einstein College of Medicine
  • Principal Investigator: Olivia Derella, Montefiore Medical Center/Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-17454
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a small pilot study, and data sharing is not planned at this stage.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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