TGNB CARE Mentalizing-Focused Parenting Groups (TGNB-CARE)

NCT05780346 | Terminated

• 1 other identifier: 2022-14551
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• To determine the feasibility and acceptability of the CARE treatment adaptation for caregivers of TGNB youth following the 12-session, mentalizing-focused, group parenting intervention. The study team hypothesizes that the adaptation and implementation of the CARE intervention will be found to be feasible and acceptable for study participants.
• To assess whether self-reported parenting stress and stressors, parental acceptance, parental reflective functioning, parent positive feelings, and perceived interpersonal support improve among study participants following the 12-session, mentalizing-focused, group parenting intervention. The study team hypothesizes that the CARE treatment group adaptation will show improvements across these outcomes. 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.

Conditions

Parent-Child Relations

Keywords

Parenting; Gender Diverse; children

Outcome Measures

Primary Outcomes (7)

• 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

• 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

Other Outcomes (5)

• Intervention Feasibility

  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

  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

  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

Study Arms (1)

CARE Parenting Group Treatment

EXPERIMENTAL

Participants (i.e., caregivers of gender diverse youth) receive the CARE mentalizing-focused group parenting intervention.

Other: TGNB-CARE (Connecting and Reflecting Experience)

Interventions

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

CARE Parenting Group Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• have a TGNB child who is receiving psychiatric services, has a mental health diagnosis, and/or has a diagnosis of gender dysphoria and is receiving medical or behavioral health services through Montefiore Medical Center and
• express interest in receiving a parenting intervention delivered via telehealth services through Montefiore Medical Center.
• In addition, subjects will:
• endorse past or current tension and/or interpersonal stress related to their child's gender identity and/or
• express interest in receiving support in the context of gender-affirming parenting.

You may not qualify if:

• Caregiver has severe mental illness or significant cognitive impairment
• Additionally, caregivers who have participated in prior or current CARE groups or have participated in any parenting support groups in the past year will be excluded from participation.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Columbia University: collaborator

Study Sites (1)

Montefiore Medical Center

New York, New York, 11216-5209, United States

Location

Study Officials

• Amanda N Zayde, PsyD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed pilot study will include four treatment groups of 6 caregivers (N = 24) receiving the 12-session, 60-minute, video telehealth group intervention.

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 22, 2023
• Study Start: June 8, 2023
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)