Trial Outcomes & Findings for Examining the Impact of Family Connectors (NCT NCT05195489)
NCT ID: NCT05195489
Last Updated: 2025-10-09
Results Overview
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.
COMPLETED
NA
28 participants
Month 1, Month 7
2025-10-09
Participant Flow
Participant milestones
| Measure |
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.
|
Comparison
Family members receive a pack of resources
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
17
|
|
Overall Study
COMPLETED
|
9
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
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.
|
Comparison
Family members receive a pack of resources
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Removed
|
0
|
1
|
Baseline Characteristics
Examining the Impact of Family Connectors
Baseline characteristics by cohort
| Measure |
Active Intervention
n=9 Participants
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.
|
Comparison
n=13 Participants
Family members receive a pack of resources
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.78 years
STANDARD_DEVIATION 13.99 • n=93 Participants
|
57.38 years
STANDARD_DEVIATION 11.84 • n=4 Participants
|
57.95 years
STANDARD_DEVIATION 12.46 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=93 Participants
|
13 participants
n=4 Participants
|
22 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Month 1, Month 7Population: The measure was not completed in full by two participants in the comparison group and one participant in the FC group.
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.
Outcome measures
| Measure |
Active Intervention
n=8 Participants
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.
|
Comparison
n=11 Participants
Family members receive a pack of resources
|
|---|---|---|
|
Change in Perceived Social Support
|
-5.06 units on a scale
Standard Deviation 7.39
|
2.91 units on a scale
Standard Deviation 8.18
|
PRIMARY outcome
Timeframe: Month 1, Month 7Population: The measure was not completed in full by four participants in the comparison group and one participant in the FC group.
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.
Outcome measures
| Measure |
Active Intervention
n=8 Participants
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.
|
Comparison
n=9 Participants
Family members receive a pack of resources
|
|---|---|---|
|
Change in Caregiver Strain
|
-2.19 units on a scale
Standard Deviation 11.32
|
0.22 units on a scale
Standard Deviation 4.41
|
PRIMARY outcome
Timeframe: Month 1, Month 7Population: The measure was not completed in full by one participant in the comparison group and two participants in the FC group.
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.
Outcome measures
| Measure |
Active Intervention
n=7 Participants
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.
|
Comparison
n=12 Participants
Family members receive a pack of resources
|
|---|---|---|
|
Change in Perceived Self-efficacy
|
-0.29 units on a scale
Standard Deviation 3.31
|
-0.46 units on a scale
Standard Deviation 2.25
|
Adverse Events
Active Intervention
Comparison
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place