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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-08

Study Completion Date

2023-07-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CARE Mentalizing-Focused Parenting Group Outcomes Study

NCT04580459

Parent-Child Relationship Parenting

COMPLETED NA

Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria

NCT05903911

Gender Dysphoria

COMPLETED NA

Reducing Transphobia Among Adolescents Through a Brief Video Intervention

NCT04969003

Transgenderism Depression

COMPLETED NA

Feasibility and Acceptability of Mindful Self-Compassion Among Transgender and Nonbinary Young Adults

NCT06409975

Healthy

RECRUITING NA

LGBTQ-affirmative CBT for Youth

NCT05408858

Anxiety Disorders Depression LGBTQ

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parent-Child Relations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CARE Parenting Group Treatment

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

Group Type EXPERIMENTAL

TGNB-CARE (Connecting and Reflecting Experience)

Intervention Type OTHER

12 session 60-minute mentalizing-focused parenting group with approximately 6 caregivers, facilitated by a mental health clinician

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TGNB-CARE (Connecting and Reflecting Experience)

12 session 60-minute mentalizing-focused parenting group with approximately 6 caregivers, facilitated by a mental health clinician

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes