Parenting StressMale-CARENCT07419308
A Male Caregiver Adaptation Study of the Connecting and Reflecting Experience Parenting Program
A study testing Connecting and Reflecting Experience (CARE) Program in people with Parenting Stress and Parent Child Relationship, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting Stress, Parent Child Relationship, Father-Child Relations
- What is being tested?
- Connecting and Reflecting Experience (CARE) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Montefiore ACUTE Psychiatry
The Bronx, New York, 10461
About this study
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
- Being tested
- Connecting and Reflecting Experience (CARE) Program
- Keywords
- Male caregivers, Fatherhood, Group therapy, Mentalizing, Parental reflective functioning, Attachment, Emotional engagement
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connecting and Reflecting Experience (CARE) ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Connecting and Reflecting Experience (CARE) Program | Experimental | Participants will enroll in a 12-session CARE parenting group therapy. Receives: Behavioral: Connecting and Reflecting Experience (CARE) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Time Frame: This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start19 Mar 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Parenting StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivia Derella, Principal investigator, Montefiore Medical Center/Albert Einstein College of MedicineAmanda Zayde, Psy.D., Principal investigator, Montefiore Medical Center/Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419308
- Sponsor's protocol ID
- 2025-17454
- Other IDs
- 2025
- Acronym
- Male-CARE
- Status last verified
- Sep 2026
- First submitted
- 10 Feb 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small pilot study, and data sharing is not planned at this stage.
Publications
Abidin, R. R. (2012). Parenting Stress Index (4th ed.) Short Form manual. PAR, Inc.
Benbassat, N., & Priel, B. (2012). Fathers' reflective function and their children's psychopathology: Intergenerational transmission of risk? Journal of Family Psychology, 26(5), 915-925
Berke DS, Reidy DE, Gentile B, Zeichner A. Masculine Discrepancy Stress, Emotion-Regulation Difficulties, and Intimate Partner Violence. J Interpers Violence. 2016 May 24;34(6):1163-1182. doi: 10.1177/0886260516650967. Print 2019 Mar 1.
PubMed 27226013Burlingame, G. M., Wells, M. G., & Lambert, M. J. (1996). Youth Outcome Questionnaire. In M. J. Lambert (Ed.), The use of psychological testing for treatment planning and outcome assessment (pp. 403-429). Lawrence Erlbaum Associates
Chatmon BN. Males and Mental Health Stigma. Am J Mens Health. 2020 Jul-Aug;14(4):1557988320949322. doi: 10.1177/1557988320949322. No abstract available.
PubMed 32812501Cohn, A. M., Jakupcak, M., Seibert, L. A., Hildebrandt, T. B., & Zeichner, A. (2010). The role of emotion dysregulation in the association between men's restrictive emotionality and use of physical aggression. Psychology of Men & Masculinity, 11(1), 53-62
Cronholm PF, Forke CM, Wade R, Bair-Merritt MH, Davis M, Harkins-Schwarz M, Pachter LM, Fein JA. Adverse Childhood Experiences: Expanding the Concept of Adversity. Am J Prev Med. 2015 Sep;49(3):354-61. doi: 10.1016/j.amepre.2015.02.001.
PubMed 26296440Epstein, N. B., Baldwin, L. M., & Bishop, D. S. (1983). The McMaster Family Assessment Device. Journal of Marital and Family Therapy, 9(2), 171-180
Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
PubMed 9635069Fonagy, P., Gergely, G., Jurist, E. L., & Target, M. (2002). Affect regulation, mentalization, and the development of the self. Other Press.
Fonagy P, Target M. Attachment and reflective function: their role in self-organization. Dev Psychopathol. 1997 Fall;9(4):679-700. doi: 10.1017/s0954579497001399.
PubMed 9449001Jakupcak, M., Salters, K., Gratz, K. L., & Roemer, L. (2003). Masculinity and emotionality: An investigation of men's primary and secondary emotional responding. Sex Roles, 49(3), 111-120.
Jakupcak, M., Tull, M. T., & Roemer, L. (2005). Masculinity, shame, and fear of emotions as predictors of men's expressions of anger and hostility. Psychology of Men & Masculinity, 6(4), 275-284
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.
Katzman, W., & Papouchis, N. (2025). Fathers' reflective functioning: Its relationship to traditional masculine ideology, alexithymia, and emotion socialization [Manuscript submitted for publication]. Department of Clinical Psychology, Long Island University, Brooklyn.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Male Caregiver Adaptation Study of the Connecting and Reflecting Experience Parenting Program
- ClinicalTrials.gov ID
- NCT07419308
- Acronym / sponsor ID
- Male-CARE / 2025-17454
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Connecting and Reflecting Experience (CARE) Program | Experimental | Behavioral: Connecting and Reflecting Experience (CARE) ProgramParticipants will enroll in a 12-session CARE parenting group therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connecting and Reflecting Experience (CARE) ProgramThe 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. | Behavioural | Connecting and Reflecting Experience (CARE) Program |
Primary outcome
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.
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.
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.
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).
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.
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.
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.
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- BackgroundAbidin, R. R. (2012). Parenting Stress Index (4th ed.) Short Form manual. PAR, Inc.
- BackgroundBenbassat, N., & Priel, B. (2012). Fathers' reflective function and their children's psychopathology: Intergenerational transmission of risk? Journal of Family Psychology, 26(5), 915-925
- Background: PubMed 27226013Berke DS, Reidy DE, Gentile B, Zeichner A. Masculine Discrepancy Stress, Emotion-Regulation Difficulties, and Intimate Partner Violence. J Interpers Violence. 2016 May 24;34(6):1163-1182. doi: 10.1177/0886260516650967. Print 2019 Mar 1.
- BackgroundBurlingame, G. M., Wells, M. G., & Lambert, M. J. (1996). Youth Outcome Questionnaire. In M. J. Lambert (Ed.), The use of psychological testing for treatment planning and outcome assessment (pp. 403-429). Lawrence Erlbaum Associates
- Background: PubMed 32812501Chatmon BN. Males and Mental Health Stigma. Am J Mens Health. 2020 Jul-Aug;14(4):1557988320949322. doi: 10.1177/1557988320949322. No abstract available.
- BackgroundCohn, A. M., Jakupcak, M., Seibert, L. A., Hildebrandt, T. B., & Zeichner, A. (2010). The role of emotion dysregulation in the association between men's restrictive emotionality and use of physical aggression. Psychology of Men & Masculinity, 11(1), 53-62
- Background: PubMed 26296440Cronholm PF, Forke CM, Wade R, Bair-Merritt MH, Davis M, Harkins-Schwarz M, Pachter LM, Fein JA. Adverse Childhood Experiences: Expanding the Concept of Adversity. Am J Prev Med. 2015 Sep;49(3):354-61. doi: 10.1016/j.amepre.2015.02.001.
- BackgroundEpstein, N. B., Baldwin, L. M., & Bishop, D. S. (1983). The McMaster Family Assessment Device. Journal of Marital and Family Therapy, 9(2), 171-180
- Background: PubMed 9635069Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
- BackgroundFonagy, P., Gergely, G., Jurist, E. L., & Target, M. (2002). Affect regulation, mentalization, and the development of the self. Other Press.
- Background: PubMed 9449001Fonagy P, Target M. Attachment and reflective function: their role in self-organization. Dev Psychopathol. 1997 Fall;9(4):679-700. doi: 10.1017/s0954579497001399.
- BackgroundJakupcak, M., Salters, K., Gratz, K. L., & Roemer, L. (2003). Masculinity and emotionality: An investigation of men's primary and secondary emotional responding. Sex Roles, 49(3), 111-120.
- Individual participant dataSharing planned: No. This is a small pilot study, and data sharing is not planned at this stage.
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Mental Health, Parenting Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivia Derella principal investigator
Montefiore Medical Center/Albert Einstein College of Medicine
Amanda Zayde, Psy.D. principal investigator
Montefiore Medical Center/Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connecting and Reflecting Experience (CARE) Program in people with Parenting Stress and Parent Child Relationship, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07419308, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.