An interventional study of Connecting and Reflecting Experience (CARE) Program in Parenting Stress, Parent Child Relationship and Father-Child Relations, sponsored by Montefiore Medical Center. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Treatment
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Among 197 studies in Emotional Regulation with a site in United States — 60 open to participants now, 76 under way, none of them phase 3. Emotional Regulation · United States.
Among the 197 studies in Emotional Regulation with a site in United States, this one is the 169th largest by planned enrollment of the 184 interventional ones that give a count, is one of 18 that started in 2026, is one of 175 with no phase, reaches primary completion later than 45 of the 75 other live ones, and was the 182nd registered.
547 studies on the registry are indexed under Emotional Regulation; 190 are open to participants now.
Browse Emotional Regulation studies →60 of the 197 studies in Emotional Regulation with a site in United States are open now. Recruiting first, the newest first:
State University of New York - Upstate Medical University · Sites in United States
Ages 12–29
University of Florida · Sites in United States
Ages 18–24 · Healthy volunteers
University of Florida · Sites in United States
Ages 18–22 · Healthy volunteers
Massachusetts General Hospital · Sites in United States
Ages 22–65
Sam Houston State University · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 136 Emotional Regulation studies recruiting now, 36 (26%) set no upper age limit and 96 (71%) stop at 75 or younger; 47 take children under 18; 66 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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197 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 4 1
First in 1988; this study’s year is marked. 18 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 14 is below the median of 80 across 500 interventional studies indexed under Emotional Regulation.
Median enrollment 74 across the 184 interventional studies, 56 across the 13 observational. Of the 112 that completed or were terminated, 18 (16%) have results posted.
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9 of 197 have an industry lead sponsor. The 10 most frequent:
Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
Montefiore Medical Center has 1 study filed under Emotional Regulation — fewer than ten, so there is no comparison to draw.
28 of the studies in Emotional Regulation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05414708Walter Reed National Military Medical CenterArt Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms | 2026-12 |
| NCT06019377Portland State UniversityIntervention to Enhance Coping and Help-seeking Among Youth in Foster Care | 2026-12-31 |
| NCT06755827Texas Tech UniversityPilot Testing a Novel Approach to Pediatric Obesity Treatment | 2026-12-31 |
| NCT05651295Matthew Southward, PhDA Precision Medicine Approach to Target Engagement for Emotion Regulation | 2026-12-31 |
| NCT05781100California Polytechnic State University-San Luis ObispoInvestigating Baby Behavior and Family Technology Use Study | 2027-01-01 |
Add all 28 to your calendar (.ics) → With an account.
Among the 197 studies in Emotional Regulation with a site in United States, from their registry updates:
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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.
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Exclusion Criteria:
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.
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.
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 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.
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 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.
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 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).
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).
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.
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 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.
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 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.
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
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).
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 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: Time Frame: This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Plan to share: No — This is a small pilot study, and data sharing is not planned at this stage.
Started Mar 2026 (actual). Primary completion is estimated for Jul 2027, 16 months after the start.
Of 391 non-industry interventional studies with no phase under Emotional Regulation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 16 months is below that.
Counting every sponsor, half of 397 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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