Caregiver Stress SyndromeNCT05195489
Examining the Impact of Family Connectors
A study testing Family Connectors in people with Caregiver Stress Syndrome, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to understand the impact of Family Connectors, a peer-to-peer support and education program for family members who have participated in OnTrackNY, a treatment program for adolescents and young adults. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Stress Syndrome
- What is being tested?
- Family Connectors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 11 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking, due to the study materials not being validated in other languages.
- 18 years of age or older,
- Family member of adolescents/young adults with first episode psychosis who participated in OnTrackNY.
Who cannot join
- Does not provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to understand the impact of Family Connectors, a peer-to-peer support and education program for family members who have participated in OnTrackNY, a treatment program for adolescents and young adults.
Read the detailed description
The study objectives are to examine the association between involvement in Family Connectors, a manualized peer-to-peer support and education program for family members of adolescents or young adults with symptoms of first episode psychosis, and feelings of empowerment, self-efficacy and social support.
- Conditions
- Caregiver Stress Syndrome
- Being tested
- Family Connectors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family ConnectorsOther
The Family Connectors Program is a manualized program that uses a time-limited parent-to parent (i.e. peer parent) support and education program delivered by phone to families of youth with serious mental health difficulties, assisting family members in becoming fully engaged with provider teams who coordinate and provide care. Family Connectors is delivered weekly by phone over the course of between three and six months.
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention | Experimental | Family members participate in Connectors by phone and receive a packet of resources Receives: Other: Family Connectors |
| Comparison | No intervention | Family members receive a pack of resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Social Support
Perceived social support is measured by a 13-item self-reported questionnaire. The subject is asked to rate each statement about social support on a scale of 1-7 (1=very strongly disagree, 2=strongly disagree, 3=disagree, 4=neither agree nor disagree, 5=agree, 6=strongly agree, 7=very strongly agree). Scores range from 13-91. Higher scores indicate stronger social support.
Measured: Month 1, Month 7
Change in Caregiver Strain
Caregiver strain is measured by a 10-tiem self-reported questionnaire. The subject is asked to rate each statement relating to caregiver strain on a scale of 1-5 (1=not at all, 2=a little, 3=somewhat, 4=Quite a bit, 5=very much). Scores range from 10-50, with higher scores indicating high caregiver strain.
Measured: Month 1, Month 7
Change in Perceived Self-efficacy
Perceived self-efficacy is measured by a 7-tiem self-reported questionnaire. The subject is asked to rate each statement on a scale of 1-5 (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree). Scores range from 7-35, with higher scores indicating greater perceived self-efficacy.
Measured: Month 1, Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start7 Mar 2022
- Primary completion31 Oct 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Caregiver Stress SyndromeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kimberly Hoagwood, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195489
- Sponsor's protocol ID
- 21-01486
- Other IDs
- P50MH113662
- Status last verified
- Sep 2025
- First submitted
- 4 Jan 2022
- Last updated
- 9 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Family Connectors
- ClinicalTrials.gov ID
- NCT05195489
- Acronym / sponsor ID
- 21-01486
- Conditions
- Caregiver Stress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Posted 9 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand the impact of Family Connectors, a peer-to-peer support and education program for family members who have participated in OnTrackNY, a treatment program for adolescents and young adults.
Detailed description
The study objectives are to examine the association between involvement in Family Connectors, a manualized peer-to-peer support and education program for family members of adolescents or young adults with symptoms of first episode psychosis, and feelings of empowerment, self-efficacy and social support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Intervention | Experimental | Other: Family ConnectorsFamily members participate in Connectors by phone and receive a packet of resources |
| Comparison | No intervention | –Family members receive a pack of resources |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking, due to the study materials not being validated in other languages.
- 18 years of age or older,
- Family member of adolescents/young adults with first episode psychosis who participated in OnTrackNY.
Key exclusion criteria (1 listed)
- Does not provide informed consent.
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 |
|---|---|---|
| Family ConnectorsThe Family Connectors Program is a manualized program that uses a time-limited parent-to parent (i.e. peer parent) support and education program delivered by phone to families of youth with serious mental health difficulties, assisting family members in becoming fully engaged with provider teams who coordinate and provide care. Family Connectors is delivered weekly by phone over the course of between three and six months. | Other | Active Intervention |
Primary outcome
Change in Perceived Social Support
Time frame: Month 1, Month 7
Perceived social support is measured by a 13-item self-reported questionnaire. The subject is asked to rate each statement about social support on a scale of 1-7 (1=very strongly disagree, 2=strongly disagree, 3=disagree, 4=neither agree nor disagree, 5=agree, 6=strongly agree, 7=very strongly agree). Scores range from 13-91. Higher scores indicate stronger social support.
Change in Caregiver Strain
Time frame: Month 1, Month 7
Caregiver strain is measured by a 10-tiem self-reported questionnaire. The subject is asked to rate each statement relating to caregiver strain on a scale of 1-5 (1=not at all, 2=a little, 3=somewhat, 4=Quite a bit, 5=very much). Scores range from 10-50, with higher scores indicating high caregiver strain.
Change in Perceived Self-efficacy
Time frame: Month 1, Month 7
Perceived self-efficacy is measured by a 7-tiem self-reported questionnaire. The subject is asked to rate each statement on a scale of 1-5 (1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=strongly agree). Scores range from 7-35, with higher scores indicating greater perceived self-efficacy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Kimberly Hoagwood, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Connectors in people with Caregiver Stress Syndrome, run by NYU Langone Health 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 9 Oct 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?
Yes. Results are posted in the registry (first posted 9 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Perceived Social Support (time frame: Month 1, Month 7). The study lists 3 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 9 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.