Trial Outcomes & Findings for Journey of Transformation Curriculum for Native American Adolescents (NCT NCT05274217)
NCT ID: NCT05274217
Last Updated: 2023-10-04
Results Overview
Patterns of substance use (Monitoring the Future \[MTF\] 30-day self-report assessed on an ordinal scale \[0 occasions, 1-2 occasions, 3-5 occasions, 6-9 occasions, 10-19 occasions, 20-39 occasions, 40 or more occasions\]). Substances include tobacco, alcohol, marijuana, stimulants, inhalants, opioids, and other drugs.
TERMINATED
NA
33 participants
Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)
2023-10-04
Participant Flow
Participant milestones
| Measure |
Immediate Group
Study participants in the immediate group will be randomly assigned to start the intervention immediately at the beginning of the fall trimester.
Journey of Transformation-Native Youth Health Leadership Program curriculum: Curriculum activities will include traditional storytelling and other Native American cultural arts activities (i.e., drum making, film making), as well as Traditional Ecological Knowledge (TEK) activities and field trips. Curriculum content explains leadership skills and promotes healthy decision-making around substance use and sexual health.
|
Waitlist Group
Study participants in the waitlist group will be randomly assigned to start the intervention at the beginning of the winter trimester.
Journey of Transformation-Native Youth Health Leadership Program curriculum: Curriculum activities will include traditional storytelling and other Native American cultural arts activities (i.e., drum making, film making), as well as Traditional Ecological Knowledge (TEK) activities and field trips. Curriculum content explains leadership skills and promotes healthy decision-making around substance use and sexual health.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
0
|
|
Overall Study
COMPLETED
|
22
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
0
|
Reasons for withdrawal
| Measure |
Immediate Group
Study participants in the immediate group will be randomly assigned to start the intervention immediately at the beginning of the fall trimester.
Journey of Transformation-Native Youth Health Leadership Program curriculum: Curriculum activities will include traditional storytelling and other Native American cultural arts activities (i.e., drum making, film making), as well as Traditional Ecological Knowledge (TEK) activities and field trips. Curriculum content explains leadership skills and promotes healthy decision-making around substance use and sexual health.
|
Waitlist Group
Study participants in the waitlist group will be randomly assigned to start the intervention at the beginning of the winter trimester.
Journey of Transformation-Native Youth Health Leadership Program curriculum: Curriculum activities will include traditional storytelling and other Native American cultural arts activities (i.e., drum making, film making), as well as Traditional Ecological Knowledge (TEK) activities and field trips. Curriculum content explains leadership skills and promotes healthy decision-making around substance use and sexual health.
|
|---|---|---|
|
Overall Study
Study terminated.
|
11
|
0
|
Baseline Characteristics
Journey of Transformation Curriculum for Native American Adolescents
Baseline characteristics by cohort
| Measure |
Immediate Group
n=22 Participants
Study participants in the immediate group will be randomly assigned to start the intervention immediately at the beginning of the fall trimester.
Journey of Transformation-Native Youth Health Leadership Program curriculum: Curriculum activities will include traditional storytelling and other Native American cultural arts activities (i.e., drum making, film making), as well as Traditional Ecological Knowledge (TEK) activities and field trips. Curriculum content explains leadership skills and promotes healthy decision-making around substance use and sexual health.
|
Waitlist Group
Study participants in the waitlist group will be randomly assigned to start the intervention at the beginning of the winter trimester.
Journey of Transformation-Native Youth Health Leadership Program curriculum: Curriculum activities will include traditional storytelling and other Native American cultural arts activities (i.e., drum making, film making), as well as Traditional Ecological Knowledge (TEK) activities and field trips. Curriculum content explains leadership skills and promotes healthy decision-making around substance use and sexual health.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.4 years
n=5 Participants
|
—
|
14.4 years
n=5 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
13 Participants
n=5 Participants
|
—
|
13 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
8 Participants
n=5 Participants
|
—
|
8 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex · Unknown
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
22 Participants
n=5 Participants
|
—
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
—
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)Population: Outcome data is not available due to study termination at baseline. Therefore, post-intervention and follow-up data were not collected.
Patterns of substance use (Monitoring the Future \[MTF\] 30-day self-report assessed on an ordinal scale \[0 occasions, 1-2 occasions, 3-5 occasions, 6-9 occasions, 10-19 occasions, 20-39 occasions, 40 or more occasions\]). Substances include tobacco, alcohol, marijuana, stimulants, inhalants, opioids, and other drugs.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)Population: Outcome data is not available due to study termination at baseline. Therefore, post-intervention and follow-up data were not collected.
The Adolescent Sexual Activity Index (ASAI) is a 13-item index which assesses pre-coitus sexual behaviors and produces an 11-point scale from 0-10 (Hansen et al., 1999).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)Population: Outcome data is not available due to study termination at baseline. Therefore, post-intervention and follow-up data were not collected.
Assess intention to use alcohol, cigarettes, and marijuana in the next year (3 items) on a 5-point scale (I have already tried \[substance\], I definitely will, I probably will, I probably will not, I definitely will not). Scores are summed and standardized on a scale of 0 to 100 percent.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)Population: Outcome data is not available due to study termination at baseline. Therefore, post-intervention and follow-up data were not collected.
The Specific Event Drug and Alcohol Refusal Self-Efficacy (SEDARE) measure captures the perceived likelihood that youth will use drugs and alcohol in specific situations on a 3-point scale (Yes, No, Unsure). Higher scores reflect higher perceived ability to refuse alcohol or drugs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)Population: Outcome data is not available due to study termination at baseline. Therefore, post-intervention and follow-up data were not collected.
7 items will be used to predict safer sex intentions on a 5-point Likert scale (strongly agree to strongly disagree, where 1 is strongly agree).
Outcome measures
Outcome data not reported
Adverse Events
Immediate Group
Waitlist Group
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