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| ID | Type | Description | Link |
|---|---|---|---|
| P50MH113662 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Intervention | Experimental | Family members participate in Connectors by phone and receive a packet of resources |
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| Comparison | No Intervention | Family members receive a pack of resources |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family Connectors | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Month 1, Month 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Hoagwood, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data. Researchers who provide a methodologically sound proposal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Intervention | Family members participate in Connectors by phone and receive a packet of resources Family Connectors: 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. |
| FG001 | Comparison | Family members receive a pack of resources |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Intervention | Family members participate in Connectors by phone and receive a packet of resources Family Connectors: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The measure was not completed in full by two participants in the comparison group and one participant in the FC group. | Posted | Mean | Standard Deviation | units on a scale | Month 1, Month 7 |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Intervention | Family members participate in Connectors by phone and receive a packet of resources Family Connectors: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Hoagwood, PhD | NYU Langone Health | 240-401-4289 | Kimberly.Hoagwood@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2024 | Sep 23, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 14, 2023 | Apr 26, 2024 | ICF_000.pdf |
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|
| Withdrawal by Subject |
|
| Removed |
|
| BG001 | Comparison | Family members receive a pack of resources |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Comparison | Family members receive a pack of resources |
|
|
| Primary | 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. | The measure was not completed in full by four participants in the comparison group and one participant in the FC group. | Posted | Mean | Standard Deviation | units on a scale | Month 1, Month 7 |
|
|
|
| Primary | 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. | The measure was not completed in full by one participant in the comparison group and two participants in the FC group. | Posted | Mean | Standard Deviation | units on a scale | Month 1, Month 7 |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Comparison | Family members receive a pack of resources | 0 | 17 | 0 | 17 | 0 | 17 |
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