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

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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).

2. 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).

3. 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)

4. 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).

5. 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).

6. 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).

7. 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).

8. 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).

9. 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.

1. First posted19 Feb 2026
2. Study start19 Mar 2026
3. Primary completionJul 2027 (estimated)
4. 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.