Not provided
Not provided
Not provided
Not provided
Lack of resources and personnel available to complete study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Columbia University | OTHER |
Not provided
Not provided
Not provided
Not provided
The primary objective of this pilot intervention study is to build upon the Connecting and Reflecting Experience (CARE) clinical trial [Clinical Trials Number: NCT04580459] and evaluate the acceptability, feasibility, and preliminary outcomes of CARE when implemented via tele-health among caregivers of transgender and nonbinary (TGNB) youth (TGNB-CARE).
The main questions it aims to answer are:
Caregivers will be asked to complete surveys at baseline (T0), following their first session (T1), and at post-intervention (T2). A feedback interview will also be completed at T2.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARE Parenting Group Treatment | Experimental | Participants (i.e., caregivers of gender diverse youth) receive the CARE mentalizing-focused group parenting intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TGNB-CARE (Connecting and Reflecting Experience) | Other | 12 session 60-minute mentalizing-focused parenting group with approximately 6 caregivers, facilitated by a mental health clinician |
| Measure | Description | Time Frame |
|---|---|---|
| Change in parenting stress | Change in parenting stress will be measured by administration of a caregiver self-report survey, the Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF). The PSI-4-SF is a 36-item survey divided into three subscales: Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC), which combine to form a Total Stress scale. Items are rated on a 5-point Likert scale from "strongly disagree" (1) to "strongly agree" (5), then summed to yield subscale scores ranging from 12 to 60 and total scores 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. | Baseline (T0) and at post-intervention following completion of 12-session, 60-minute interventions (T2), an average of 18 weeks following session 1 of group |
| Change in parental stressors | Change in parental stressors will be measured by administration of a caregiver self-report, The Stressors on Families of Trans Youth Checklist (SFTYC). Each item that is endorsed by the caregiver as having occurred is scored as '1' (excluding the 'none of the above' option on the form). If the caregiver endorses 'something else' on the form, each incident mentioned that is not already captured in existing checklist items is scored an additional '1'. The sum total of the endorsed items is the final score for this measure. Higher overall scores are indicative of higher external stressors on families/caregivers. | Baseline (T0) and at post-intervention following completion of 12-session, 60-minute interventions (T2), an average of 18 weeks following session 1 of group |
| Change in parental acceptance of the gender-diverse child | Change in parental acceptance of the gender-diverse child will be assessed by administration of a caregiver self-report on the demographic questionnaire. | Baseline (T0) and at post-intervention following completion of 12-session, 60-minute interventions (T2), an average of 18 weeks following session 1 of group |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Feasibility | Intervention feasibility will be measured by Feasibility of Intervention Measure (FIM). 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. |
Inclusion Criteria:
Adult caregivers (mothers, fathers, primary caregivers, or legal guardians) who are English-speaking (as the research assessments and intervention will be conducted in English).
Participants will be caregivers who:
In addition, subjects will:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amanda N Zayde, PsyD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | New York | New York | 11216-5209 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The proposed pilot study will include four treatment groups of 6 caregivers (N = 24) receiving the 12-session, 60-minute, video telehealth group intervention.
Not provided
Not provided
Not provided
Not provided
| Change in parental reflective functioning | Change in parental reflective functioning as measured by parent/caregiver report on the Parental Reflective Functioning Questionnaire. Responses are reported on a 7-point Likert scale from 1 to 7. Total scores for the three sub-scales (Pre-Mentalizing Modes, Certainty about Mental States, and Interest and Curiosity) range from 6 to 42. Lower scores on Pre-Mentalizing Modes, moderate scores on Certainty about Mental States, and higher scores on Interest and Curiosity indicate better outcomes.. | Baseline (T0) and at post-intervention following completion of 12-session, 60-minute interventions (T2), an average of 18 weeks following session 1 of group |
| Change in Parental positive feelings about having a gender diverse child | Change in parental positive feelings about having a gender diverse child will be measured by administration of a caregiver self-report using the Trans Youth Can! Parent Positive Feelings Checklist (TYC-PPFC). Each item that is endorsed by the respondent as having occurred is scored as '1'. If the caregiver endorses 'something else', each incident mentioned that is not already captured in existing checklist items is scored an additional '1'. The sum total of the endorsed items is the final score for this measure. Higher overall scores are indicative of more positive feelings parents/caregivers of trans and non-binary youth experience in regard to their youth's gender. | Baseline (T0) and at post-intervention following completion of 12-session, 60-minute interventions (T2), an average of 18 weeks following session 1 of group |
| Change in parental worries about having a gender diverse child | Change in parental worries about having a gender diverse child will be measured by administration of a caregiver self-report using the Trans Youth Can! Parent Positive Feelings Checklist (TYC-PWC). Each item that is endorsed by the respondent as having occurred is scored as '1' (excluding the 'I have no great concerns' option which is coded as '0' and must be a unique choice if selected). If the caregiver endorses 'something else', each incident mentioned that is not already captured in existing checklist items is scored an additional '1'. The sum total of the endorsed items is the final score for this measure. Higher overall scores are associated with more potential factors that may concern parents/caregivers of trans and non-binary youth with regard to the youth's gender. | Baseline (T0) and at post-intervention following completion of 12-session, 60-minute interventions (T2), an average of 18 weeks following session 1 of group |
| Change in perceived interpersonal support | Change in perceived interpersonal support will be measured by administration of a caregiver self-report using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item scale designed to measure perceived social support from three sources: Family, Friends, and a Significant Other. All items are scored on a 7-point Likert scale, from 1 (Very Strongly disagree) to 7 (Very Strongly agree). Higher overall scores are associated with caregivers who perceive to receive greater interpersonal support from their social network. | Baseline (T0) and at post-intervention following completion of 12-session, 60-minute interventions (T2), an average of 18 weeks following session 1 of group |
| Following First CARE group session (T1) and at post-intervention following completion of 12-session, 60-minute interventions (T2), an average of 18 weeks following session 1 of group |
| Intervention Acceptability | Intervention acceptability will be measured by Acceptability of Intervention Measure (AIM). 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. | Following First CARE group session (T1) and at post-intervention following completion of 12-session, 60-minute interventions (T2), an average of 18 weeks following session 1 of group |
| Intervention Appropriateness | Intervention appropriateness will be measured by Intervention Appropriateness Measure (IAM). 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. | Following First CARE group session (T1) and at post-intervention following completion of 12-session, 60-minute interventions (T2), an average of 18 weeks following session 1 of group |
| Changes in therapeutic group cohesiveness | Change in therapeutic group cohesiveness will be assessed using the self-reported Cohesiveness subscale of the Therapeutic Factors Inventory (TFI-COH). The Therapeutic Factors Inventory is a larger battery with 11 different subscales, developed to measure the therapeutic factors in group psychotherapy. The TFI-COH subscale used in the current study specifically assesses participant experiences of bondedness, acceptance, and mutual liking and trust within a particular therapy group. The TFI-COH includes nine items rated on a 7-point Likert scale ranging from "strongly disagree" (1) to "strongly agree" (7). Two items are reverse scored and then summed with remaining items to yield total scores ranging from 9 to 63. Higher total scores are generally indicative of perceptions of greater (more positive) cohesiveness within the therapy group. | Following first CARE group session (T1) and at post-intervention following completion of 12-session, 60-minute interventions (T2), an average of 18 weeks following session 1 of group |
| Change in working alliance | Changes in therapeutic process variables will also be assessed using the using the Working Alliance Inventory - Short Form Revised (WAI-SR) scale. The WAI-SR is a 12-item patient-rated questionnaire that measures three domains of therapeutic alliance: agreement between patient and therapist on the goals of the treatment (Goal); agreement between patient and therapist about the tasks to achieve these goals (Task); and the quality of the bond between the patient and therapist (Bond). All items are scored on a 5-point Likert scale ranging from 1 ('rarely' or 'never') to 5 ('always'). Higher scores indicate a better therapeutic alliance. | Following First CARE group session (T1) and at post-intervention following completion of 12-session, 60-minute interventions (T2), an average of 18 weeks following session 1 of group |