Trial Outcomes & Findings for An Intervention to Reduce Risk Factors for Adolescent Pregnancy (NCT NCT04222959)
NCT ID: NCT04222959
Last Updated: 2024-11-05
Results Overview
Contraceptive use: Condom use and other contraception use and consistency of use.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
6 month follow-up
Results posted on
2024-11-05
Participant Flow
Unit of analysis: schools
Participant milestones
| Measure |
Girls Invest Intervention
Girls Invest intervention participants were randomized by site to receive the intervention immediately upon completion of the baseline survey. Intervention participants will also complete the 6 month follow-up survey. (n=217 total participants)
Girls Invest Mobile App Intervention: 5 levels of training on financial and health literacy Savings account and subsidies: participants receive deposits into a savings account upon completion of app-based trainings
|
Wait-List Control Condition Participants
Control condition participants will be randomized upon completion of the baseline survey and put on a wait-list to receive Girls Invest behavioral intervention after the 6 month follow-up survey. (n=50 dyads; 100 total participants)
|
|---|---|---|
|
Overall Study
STARTED
|
138 9
|
102 9
|
|
Overall Study
COMPLETED
|
62 9
|
74 9
|
|
Overall Study
NOT COMPLETED
|
76 0
|
28 0
|
Reasons for withdrawal
| Measure |
Girls Invest Intervention
Girls Invest intervention participants were randomized by site to receive the intervention immediately upon completion of the baseline survey. Intervention participants will also complete the 6 month follow-up survey. (n=217 total participants)
Girls Invest Mobile App Intervention: 5 levels of training on financial and health literacy Savings account and subsidies: participants receive deposits into a savings account upon completion of app-based trainings
|
Wait-List Control Condition Participants
Control condition participants will be randomized upon completion of the baseline survey and put on a wait-list to receive Girls Invest behavioral intervention after the 6 month follow-up survey. (n=50 dyads; 100 total participants)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
76
|
28
|
Baseline Characteristics
We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
Baseline characteristics by cohort
| Measure |
Girls Invest Intervention
n=138 Participants
Girls Invest intervention participants were randomized by site to receive the intervention immediately upon completion of the baseline survey. Intervention participants will also complete the 6 month follow-up survey. (n=217 total participants)
Girls Invest Mobile App Intervention: 5 levels of training on financial and health literacy Savings account and subsidies: participants receive deposits into a savings account upon completion of app-based trainings
|
Wait-List Control Condition Participants
n=102 Participants
Control condition participants will be randomized upon completion of the baseline survey and put on a wait-list to receive Girls Invest behavioral intervention after the 6 month follow-up survey. (n=50 dyads; 100 total participants)
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
89 Participants
n=138 Participants
|
80 Participants
n=102 Participants
|
169 Participants
n=240 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=138 Participants
|
22 Participants
n=102 Participants
|
71 Participants
n=240 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=138 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=240 Participants
|
|
Age, Continuous
|
17 years
STANDARD_DEVIATION 1.5 • n=138 Participants
|
17 years
STANDARD_DEVIATION 1.4 • n=102 Participants
|
17 years
STANDARD_DEVIATION 1.2 • n=240 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=138 Participants
|
102 Participants
n=102 Participants
|
240 Participants
n=240 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=138 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=240 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=118 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
5 Participants
n=88 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
15 Participants
n=206 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=118 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
0 Participants
n=88 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
0 Participants
n=206 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=118 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
0 Participants
n=88 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
1 Participants
n=206 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=118 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
0 Participants
n=88 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
0 Participants
n=206 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
|
Race (NIH/OMB)
White
|
9 Participants
n=118 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
1 Participants
n=88 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
10 Participants
n=206 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
|
Race (NIH/OMB)
More than one race
|
30 Participants
n=118 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
0 Participants
n=88 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
30 Participants
n=206 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
68 Participants
n=118 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
82 Participants
n=88 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
150 Participants
n=206 Participants • We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.
|
|
Region of Enrollment
United States
|
138 Participants
n=138 Participants
|
102 Participants
n=102 Participants
|
240 Participants
n=240 Participants
|
PRIMARY outcome
Timeframe: 6 month follow-upPopulation: Participants who reported having had sex in the past 6 months.
Contraceptive use: Condom use and other contraception use and consistency of use.
Outcome measures
| Measure |
Girls Invest Intervention
n=55 Participants
Girls Invest intervention participants were randomized by site to receive the intervention immediately upon completion of the baseline survey.
Girls Invest Intervention includes 2 main components:
Girls Invest Mobile App Trainings: 5 levels of training on financial and health topics
Savings account and subsidies: Participants receive deposits into a savings account upon completion of app-based trainings, totaling $100.
|
Wait-List Control Condition Participants
n=39 Participants
Control condition participants were on a wait-list to receive Girls Invest behavioral intervention after the 6 month follow-up survey.
|
|---|---|---|
|
Sexual/Reproductive Health Behaviors
|
24 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Past 6 monthsPopulation: participants who were not lost to follow-up and responded to the item
Number of participants reporting relying financially on a male partner (reported to receive spending money from a male partner or reported that a male partner buys basic necessities, such as: food, clothing, school supplies).
Outcome measures
| Measure |
Girls Invest Intervention
n=53 Participants
Girls Invest intervention participants were randomized by site to receive the intervention immediately upon completion of the baseline survey.
Girls Invest Intervention includes 2 main components:
Girls Invest Mobile App Trainings: 5 levels of training on financial and health topics
Savings account and subsidies: Participants receive deposits into a savings account upon completion of app-based trainings, totaling $100.
|
Wait-List Control Condition Participants
n=67 Participants
Control condition participants were on a wait-list to receive Girls Invest behavioral intervention after the 6 month follow-up survey.
|
|---|---|---|
|
Financial Reliance on a Male Partner
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 6 months follow-upPopulation: Participants who were not lost to follow-up
Felt down, depressed, or hopeless - 5 pt likert scale recategorized as reporting any frequency of these feelings in last 30 days versus none (assessed at 6 months follow up)
Outcome measures
| Measure |
Girls Invest Intervention
n=43 Participants
Girls Invest intervention participants were randomized by site to receive the intervention immediately upon completion of the baseline survey.
Girls Invest Intervention includes 2 main components:
Girls Invest Mobile App Trainings: 5 levels of training on financial and health topics
Savings account and subsidies: Participants receive deposits into a savings account upon completion of app-based trainings, totaling $100.
|
Wait-List Control Condition Participants
n=61 Participants
Control condition participants were on a wait-list to receive Girls Invest behavioral intervention after the 6 month follow-up survey.
|
|---|---|---|
|
Feeling Depressed
|
5 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who were not lost to follow up and responded to questions regarding feelings of depression and anxiety at follow-up.
Felt worried, tense, or anxious - 5 pt likert scale recategorized as any frequency of these feelings in the past 30 days versus no days reporting these feelings (assessed at 6 months follow-up)
Outcome measures
| Measure |
Girls Invest Intervention
n=43 Participants
Girls Invest intervention participants were randomized by site to receive the intervention immediately upon completion of the baseline survey.
Girls Invest Intervention includes 2 main components:
Girls Invest Mobile App Trainings: 5 levels of training on financial and health topics
Savings account and subsidies: Participants receive deposits into a savings account upon completion of app-based trainings, totaling $100.
|
Wait-List Control Condition Participants
n=61 Participants
Control condition participants were on a wait-list to receive Girls Invest behavioral intervention after the 6 month follow-up survey.
|
|---|---|---|
|
Felt Worried, Tense, or Anxious
|
8 Participants
|
27 Participants
|
Adverse Events
Girls Invest Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-List Control Condition 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
Elizabeth Reed
San Diego State University Research Foundation
Phone: 508-212-1517
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place