Clinical trial NCT05780346: TGNB CARE Mentalizing-Focused Parenting Groups (TGNB-CARE)
Official title: Pilot Trial of Mentalizing-Focused Parenting Groups for Caregivers of Gender Diverse Youth
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parent-Child Relations
Keywords: Parenting
Gender Diverse
children
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2023-03-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The proposed pilot study will include four treatment groups of 6 caregivers (N = 24) receiving the 12-session, 60-minute, video telehealth group intervention.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

  1. 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
  2. express interest in receiving a parenting intervention delivered via telehealth services through Montefiore Medical Center.

In addition, subjects will:

1. endorse past or current tension and/or interpersonal stress related to their child's gender identity and/or
2. express interest in receiving support in the context of gender-affirming parenting.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in parenting stress
timeFrame: 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
measure: Change in parental stressors
timeFrame: 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
measure: Change in parental acceptance of the gender-diverse child
timeFrame: 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
measure: Change in parental reflective functioning
timeFrame: 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
measure: Change in Parental positive feelings about having a gender diverse child
timeFrame: 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
measure: Change in parental worries about having a gender diverse child
timeFrame: 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
measure: Change in perceived interpersonal support
timeFrame: 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
Secondary outcomes:
Other outcomes:
measure: Intervention Feasibility
timeFrame: 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
measure: Intervention Acceptability
timeFrame: 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
measure: Intervention Appropriateness
timeFrame: 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
measure: Changes in therapeutic group cohesiveness
timeFrame: 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
measure: Change in working alliance
timeFrame: 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
Locations:
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Amanda N Zayde, PsyD
role: PRINCIPAL_INVESTIGATOR
References: