Trial Outcomes & Findings for Increasing Teen Access to Sexual and Mental Health Care (NCT NCT05444855)
NCT ID: NCT05444855
Last Updated: 2024-09-19
Results Overview
Measurement of any use of healthcare utilization through trial. Healthcare utilization measured through surveys from participants at baseline, 2 months, 4 months, and 6 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2024-09-19
Participant Flow
In the protocol, we use the target enrollment number of 100 participants. However, our actual participants were 51 enrolled, which is reflected in our results section.
Participant milestones
| Measure |
Peer Leader Participants
Peer Leaders
Investigators will enroll up to 40 Peer Leaders. In addition to the above activities (under intervention trial participant), if a teen is a "peer leader" they will attend a training session in-person or online with our study team to learn about sexual and mental health information and how to share information with their friends (like text or social media). The peer leaders will answer the same surveys described above and will be asked about their Peer Leader experience and how they are sharing the study health information.
|
Friend Network Participants
Teens will have an opportunity to interact with established peer leaders that are a part of the AccessKCTeen program. These leaders will receive a baseline training of their role, sexual and mental health. They will also receive health education and engage with a peer liaison via text messages throughout the study.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
33
|
|
Overall Study
COMPLETED
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
7
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increasing Teen Access to Sexual and Mental Health Care
Baseline characteristics by cohort
| Measure |
Peer Leader Participants
n=18 Participants
Peer Leaders
Investigators will enroll up to 40 Peer Leaders. In addition to the above activities (under intervention trial participant), if a teen is a "peer leader" they will attend a training session in-person or online with our study team to learn about sexual and mental health information and how to share information with their friends (like text or social media). The peer leaders will answer the same surveys described above and will be asked about their Peer Leader experience and how they are sharing the study health information.
|
Friend Network Participants
n=33 Participants
Teens will have an opportunity to interact with established peer leaders that are a part of the AccessKCTeen program. These leaders will receive a baseline training of their role, sexual and mental health. They will also receive health education and engage with a peer liaison via text messages throughout the study.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15 years
n=5 Participants
|
16 years
n=7 Participants
|
16 years
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
7 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-binary
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
13 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race/other
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Amer Indian/Alaskan Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsMeasurement of any use of healthcare utilization through trial. Healthcare utilization measured through surveys from participants at baseline, 2 months, 4 months, and 6 months.
Outcome measures
| Measure |
Peer Leader Participants
n=18 Participants
Peer Leaders
Investigators will enroll up to 40 Peer Leaders. In addition to the above activities (under intervention trial participant), if a teen is a "peer leader" they will attend a training session in-person or online with our study team to learn about sexual and mental health information and how to share information with their friends (like text or social media). The peer leaders will answer the same surveys described above and will be asked about their Peer Leader experience and how they are sharing the study health information.
|
Friend Network Participants
n=33 Participants
Teens will have an opportunity to interact with established peer leaders that are a part of the AccessKCTeen program. These leaders will receive a baseline training of their role, sexual and mental health. They will also receive health education and engage with a peer liaison via text messages throughout the study.
|
|---|---|---|
|
Number of Participants With Any Healthcare Utilization From Baseline to 6 Months
|
9 Participants
|
7 Participants
|
Adverse Events
Peer Leader Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Friend Network Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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