Caregiver Stress Syndrome
Conditions
Brief 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.
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.
Interventions
OTHERFamily 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.
Sponsors
National Institute of Mental Health (NIMH)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Does not provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Social Support | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| Comparison Family members receive a pack of resources | 13 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Removed | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Active Intervention | Total | Comparison |
|---|---|---|---|
| Age, Continuous | 58.78 years STANDARD_DEVIATION 13.99 | 57.95 years STANDARD_DEVIATION 12.46 | 57.38 years STANDARD_DEVIATION 11.84 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 17 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 3 Participants | 10 Participants | 7 Participants |
| Region of Enrollment United States | 9 participants | 22 participants | 13 participants |
| Sex: Female, Male Female | 8 Participants | 18 Participants | 10 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 17 |
| other Total, other adverse events | 0 / 11 | 0 / 17 |
| serious Total, serious adverse events | 0 / 11 | 0 / 17 |
Outcome results
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.
Time frame: Month 1, Month 7
Population: The measure was not completed in full by four participants in the comparison group and one participant in the FC group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Intervention | Change in Caregiver Strain | -2.19 units on a scale | Standard Deviation 11.32 |
| Comparison | Change in Caregiver Strain | 0.22 units on a scale | Standard Deviation 4.41 |
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.
Time frame: Month 1, Month 7
Population: The measure was not completed in full by one participant in the comparison group and two participants in the FC group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Intervention | Change in Perceived Self-efficacy | -0.29 units on a scale | Standard Deviation 3.31 |
| Comparison | Change in Perceived Self-efficacy | -0.46 units on a scale | Standard Deviation 2.25 |
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.
Time frame: Month 1, Month 7
Population: The measure was not completed in full by two participants in the comparison group and one participant in the FC group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Intervention | Change in Perceived Social Support | -5.06 units on a scale | Standard Deviation 7.39 |
| Comparison | Change in Perceived Social Support | 2.91 units on a scale | Standard Deviation 8.18 |