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.
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.
Brief Title
A Male Caregiver Adaptation Study of the Connecting and Reflecting Experience Parenting Program
Completion Date
Completion Date Type
Estimated
Conditions
Parenting Stress
Parent Child Relationship
Father-Child Relations
Emotional Regulation
Fathers
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Male caregivers
Fatherhood
Group therapy
Mentalizing
Parental reflective functioning
Attachment
Emotional engagement
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07419308
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2025-17454
Overall Status
Enrolling by invitation
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Male Caregiver Adaptation Study of the Connecting and Reflecting Experience Parenting Program
Primary Outcomes
Outcome Description
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.
Outcome Measure
Change from Baseline to Post-Treatment in Parenting Stress
Outcome 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).
Outcome Description
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.
Outcome Measure
Change from Baseline to Post-Treatment in Parental Reflective Functioning
Outcome 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).
Outcome Description
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.
Outcome Measure
Change from Baseline to Post-Treatment in Restrictive Emotionality
Outcome 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)
Outcome Description
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).
Outcome Measure
Change from First Session to Post-Treatment in Therapeutic Group Processes
Outcome 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).
Outcome Description
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.
Outcome Measure
Post-Treatment Ratings of Feasibility
Outcome Time Frame
This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Outcome Description
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.
Outcome Measure
Post-Treatment Ratings of Acceptability
Outcome Time Frame
This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Outcome Description
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.
Outcome Measure
Post-Treatment Ratings of Appropriateness
Outcome Time Frame
This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Outcome Description
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).
Outcome Measure
Post-Treatment Ratings of Outcomes and Feedback
Outcome Time Frame
This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Outcome Description
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.
Outcome Measure
Post-Treatment Participant Group Attendance
Outcome 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).
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Olivia Derella
Investigator Email
olivia.derella@einsteinmed.edu
Study Department
Psychiatry and Behavioral Sciences
Study Division
Please Specify
MeSH Terms
EMOTIONAL REGULATION
SELF-CONTROL
SOCIAL BEHAVIOR
BEHAVIOR