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NCT05780346 · ClinicalTrials.gov registry record · NA
TGNB CARE Mentalizing-Focused Parenting Groups (TGNB-CARE)
A NA study, sponsored by Montefiore Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT05780346: Clinical Trial NA study, sponsored by Montefiore Medical Center.
NCT05780346 is a NA study that was terminated before completion, run by Montefiore Medical Center. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05780346, a NA study, was terminated before completion, sponsored by Montefiore Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
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 score
Interventions
- OTHER TGNB-CARE (Connecting and Reflecting Experience)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2023-06-08 |
| Est. Completion | 2023-07-17 |
| Phase | NA |
Why NCT05780346 stopped before completion
NCT05780346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which TGNB-CARE (Connecting and Reflecting Experience) is the first listed.
NCT05780346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05780346 about?
NCT05780346 is a clinical study titled "TGNB CARE Mentalizing-Focused Parenting Groups (TGNB-CARE)". 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 caregive...
What is the current status of trial NCT05780346?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2023-06-08. Estimated completion is 2023-07-17.
What interventions are being tested in trial NCT05780346?
The interventions under investigation include: TGNB-CARE (Connecting and Reflecting Experience) (OTHER).
Who is sponsoring clinical trial NCT05780346?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05780346's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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