A Male Caregiver Adaptation Study of the Connecting and Reflecting Experience Parenting Program

NCT07419308 | Enrolling By Invitation

• 1 other identifier: 2025-17454
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parenting Stress; Parent Child Relationship; Father-Child Relations; Emotional Regulation; Fathers

Keywords

Male caregivers; Fatherhood; Group therapy; Mentalizing; Parental reflective functioning; Attachment; Emotional engagement

Outcome Measures

Primary Outcomes (9)

• Change from Baseline to Post-Treatment in Parenting Stress

  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

  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

  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

  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

  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

  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

  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 Ratings of Outcomes and Feedback

  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).

• Post-Treatment Participant Group Attendance

  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).

Study Arms (1)

Connecting and Reflecting Experience (CARE) Program

EXPERIMENTAL

Participants will enroll in a 12-session CARE parenting group therapy.

Behavioral: Connecting and Reflecting Experience (CARE) Program

Interventions

Connecting and Reflecting Experience (CARE) Program BEHAVIORAL

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.

Connecting and Reflecting Experience (CARE) Program

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Parents or primary caregivers who identify as male or who identify with a male caregiving role-this includes, but is not limited to, cisgender, transgender, genderqueer, or nonbinary fathers; stepfathers; grandfathers; uncles; or other male guardians.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore ACUTE Psychiatry

The Bronx, New York, 10461, United States

Location

Related Publications (5)

• Abidin, R. R. (2012). Parenting Stress Index (4th ed.) Short Form manual. PAR, Inc.

  BACKGROUND

• Joyce, A. S., MacNair-Semands, R., Tasca, G. A., & Ogrodniczuk, J. S. (2011). Factor structure and validity of the Therapeutic Factors Inventory-Short Form. Group Dynamics: Theory, Research, and Practice, 15(3), 201.

  BACKGROUND

• Levant, R. F., Smalley, K. B., Aupont, M., House, A. T., Richmond, K., & Noronha, D. (2007). Initial validation of the male role norms inventory-revised (MRNI-R). The Journal of men's Studies, 15(1), 83-100.

  BACKGROUND

• Luyten P, Mayes LC, Nijssens L, Fonagy P. The parental reflective functioning questionnaire: Development and preliminary validation. PLoS One. 2017 May 4;12(5):e0176218. doi: 10.1371/journal.pone.0176218. eCollection 2017.

  PMID: 28472162 BACKGROUND

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Olivia Derella

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Amanda Zayde, Psy.D.

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 19, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)