Parent-Child RelationsTGNB-CARENCT05780346
TGNB CARE Mentalizing-Focused Parenting Groups (TGNB-CARE)
A study testing TGNB-CARE (Connecting and Reflecting Experience) in people with Parent-Child Relations, run by Montefiore Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations
- What is being tested?
- TGNB-CARE (Connecting and Reflecting Experience)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2023to 17 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
New York, New York, 11216-5209
About this study
Official title: Pilot Trial of Mentalizing-Focused Parenting Groups for Caregivers of Gender Diverse Youth
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:
Read more
- 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
- Being tested
- TGNB-CARE (Connecting and Reflecting Experience)
- Keywords
- Parenting, Gender Diverse, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| CARE Parenting Group Treatment | Experimental | Participants (i.e., caregivers of gender diverse youth) receive the CARE mentalizing-focused group parenting intervention. Receives: Other: TGNB-CARE (Connecting and Reflecting Experience) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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..
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start8 Jun 2023
- Primary completion17 Jul 2023
- Study completion17 Jul 2023
Why it stopped: Lack of resources and personnel available to complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Amanda N Zayde, PsyD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780346
- Sponsor's protocol ID
- 2022-14551
- Acronym
- TGNB-CARE
- Status last verified
- May 2025
- First submitted
- 13 Feb 2023
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Mentalizing-Focused Parenting Groups for Caregivers of Gender Diverse Youth
- ClinicalTrials.gov ID
- NCT05780346
- Acronym / sponsor ID
- TGNB-CARE / 2022-14551
- Conditions
- Parent-Child Relations
- Keywords
- Parenting, Gender Diverse, children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of resources and personnel available to complete study
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| CARE Parenting Group Treatment | Experimental | Other: TGNB-CARE (Connecting and Reflecting Experience)Participants (i.e., caregivers of gender diverse youth) receive the CARE mentalizing-focused group parenting intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TGNB-CARE (Connecting and Reflecting Experience)12 session 60-minute mentalizing-focused parenting group with approximately 6 caregivers, facilitated by a mental health clinician | Other | CARE Parenting Group Treatment |
Primary outcome
Change in parenting stress
Time frame: 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 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.
Change in parental stressors
Time frame: 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 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.
Change in parental acceptance of the gender-diverse child
Time frame: 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 will be assessed by administration of a caregiver self-report on the demographic questionnaire.
Change in parental reflective functioning
Time frame: 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 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..
Change in Parental positive feelings about having a gender diverse child
Time frame: 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 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.
Change in parental worries about having a gender diverse child
Time frame: 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 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.
Change in perceived interpersonal support
Time frame: 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 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.
Results and safety
The study was stopped early (reason given: Lack of resources and personnel available to complete study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda N Zayde, PsyD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TGNB-CARE (Connecting and Reflecting Experience) in people with Parent-Child Relations, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of resources and personnel available to complete study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parenting stress (time frame: 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.