Trial Outcomes & Findings for A Risky Sex Prevention Intervention for Middle School Age Minority Girls (NCT NCT02103218)
NCT ID: NCT02103218
Last Updated: 2021-06-16
Results Overview
Adolescent Sexual Activity Index (Female). The theoretical minimum and maximum values are min=0 and max=10 (Hansen, Paskett, \& Carter, 1999). A higher index value indicates more activity (worse outcome).
COMPLETED
NA
212 participants
12 months
2021-06-16
Participant Flow
Participant milestones
| Measure |
Risky Sex Prevention-Daughters
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors-Daughters
General health education, activities
|
Risky Sex Prevention-Mothers
Activities, empowerment, communication...
|
Healthy Behaviors-Mothers
General health education, activities
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
59
|
48
|
54
|
|
Overall Study
COMPLETED
|
46
|
51
|
44
|
47
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
4
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only daughters (n=110) were analyzed for middle school grade.
Baseline characteristics by cohort
| Measure |
Risky Sex Prevention-Daughters
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors-Daughters
n=59 Participants
General health education, activities
|
Risky Sex Prevention-Mothers
n=48 Participants
Activities, empowerment, communication.....
|
Healthy Behaviors-Mothers
n=54 Participants
General health education, activities
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
12.4 years
STANDARD_DEVIATION 0.70 • n=51 Participants
|
12.7 years
STANDARD_DEVIATION 0.94 • n=59 Participants
|
40.9 years
STANDARD_DEVIATION 10.3 • n=48 Participants
|
37.8 years
STANDARD_DEVIATION 6.39 • n=54 Participants
|
25.7 years
STANDARD_DEVIATION 14.6 • n=212 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=51 Participants
|
59 Participants
n=59 Participants
|
48 Participants
n=48 Participants
|
54 Participants
n=54 Participants
|
212 Participants
n=212 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=51 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=212 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African-American
|
30 Participants
n=51 Participants
|
48 Participants
n=59 Participants
|
38 Participants
n=48 Participants
|
48 Participants
n=54 Participants
|
164 Participants
n=212 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Mixed
|
21 Participants
n=51 Participants
|
11 Participants
n=59 Participants
|
6 Participants
n=48 Participants
|
2 Participants
n=54 Participants
|
40 Participants
n=212 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic/Latino
|
0 Participants
n=51 Participants
|
0 Participants
n=59 Participants
|
2 Participants
n=48 Participants
|
0 Participants
n=54 Participants
|
2 Participants
n=212 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
0 Participants
n=51 Participants
|
0 Participants
n=59 Participants
|
2 Participants
n=48 Participants
|
4 Participants
n=54 Participants
|
6 Participants
n=212 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=51 Participants
|
59 participants
n=59 Participants
|
48 participants
n=48 Participants
|
54 participants
n=54 Participants
|
212 participants
n=212 Participants
|
|
Current Grade
6th grade
|
22 Participants
n=51 Participants • Only daughters (n=110) were analyzed for middle school grade.
|
21 Participants
n=59 Participants • Only daughters (n=110) were analyzed for middle school grade.
|
—
|
—
|
43 Participants
n=110 Participants • Only daughters (n=110) were analyzed for middle school grade.
|
|
Current Grade
7th grade
|
23 Participants
n=51 Participants • Only daughters (n=110) were analyzed for middle school grade.
|
21 Participants
n=59 Participants • Only daughters (n=110) were analyzed for middle school grade.
|
—
|
—
|
44 Participants
n=110 Participants • Only daughters (n=110) were analyzed for middle school grade.
|
|
Current Grade
8th grade
|
6 Participants
n=51 Participants • Only daughters (n=110) were analyzed for middle school grade.
|
17 Participants
n=59 Participants • Only daughters (n=110) were analyzed for middle school grade.
|
—
|
—
|
23 Participants
n=110 Participants • Only daughters (n=110) were analyzed for middle school grade.
|
|
Racial Pride
|
21.0 units on a scale
STANDARD_DEVIATION 4.2 • n=51 Participants • This measure was not assessed for Mothers.
|
21.3 units on a scale
STANDARD_DEVIATION 4.3 • n=59 Participants • This measure was not assessed for Mothers.
|
—
|
—
|
21.2 units on a scale
STANDARD_DEVIATION 4.3 • n=110 Participants • This measure was not assessed for Mothers.
|
|
Maternal Monitoring Scale
Daughters only
|
34.8 units on a scale
STANDARD_DEVIATION 4.2 • n=51 Participants • Two separate scales: From daughter's perspective and mother's perspective. Should be kept separate like previous literature. They each have their own reliability (alpha = .70 for daughters and .58 for mothers) and should NOT be averaged over daughters and mothers. We therefore present data by 2 rows: (a) for Daughters only and (b) for Mothers only.
|
35.2 units on a scale
STANDARD_DEVIATION 4.3 • n=59 Participants • Two separate scales: From daughter's perspective and mother's perspective. Should be kept separate like previous literature. They each have their own reliability (alpha = .70 for daughters and .58 for mothers) and should NOT be averaged over daughters and mothers. We therefore present data by 2 rows: (a) for Daughters only and (b) for Mothers only.
|
—
|
—
|
35.0 units on a scale
STANDARD_DEVIATION 4.2 • n=110 Participants • Two separate scales: From daughter's perspective and mother's perspective. Should be kept separate like previous literature. They each have their own reliability (alpha = .70 for daughters and .58 for mothers) and should NOT be averaged over daughters and mothers. We therefore present data by 2 rows: (a) for Daughters only and (b) for Mothers only.
|
|
Maternal Monitoring Scale
Mothers only
|
—
|
—
|
37.4 units on a scale
STANDARD_DEVIATION 2.6 • n=48 Participants • Two separate scales: From daughter's perspective and mother's perspective. Should be kept separate like previous literature. They each have their own reliability (alpha = .70 for daughters and .58 for mothers) and should NOT be averaged over daughters and mothers. We therefore present data by 2 rows: (a) for Daughters only and (b) for Mothers only.
|
37.4 units on a scale
STANDARD_DEVIATION 2.2 • n=54 Participants • Two separate scales: From daughter's perspective and mother's perspective. Should be kept separate like previous literature. They each have their own reliability (alpha = .70 for daughters and .58 for mothers) and should NOT be averaged over daughters and mothers. We therefore present data by 2 rows: (a) for Daughters only and (b) for Mothers only.
|
37.4 units on a scale
STANDARD_DEVIATION 2.4 • n=102 Participants • Two separate scales: From daughter's perspective and mother's perspective. Should be kept separate like previous literature. They each have their own reliability (alpha = .70 for daughters and .58 for mothers) and should NOT be averaged over daughters and mothers. We therefore present data by 2 rows: (a) for Daughters only and (b) for Mothers only.
|
|
Mother-Adolescent Communication: Open Family Communication
Daughters only
|
38.1 units on a scale
STANDARD_DEVIATION 9.0 • n=51 Participants • Two separate scales: One from daughter's perspective and mother's perspective. They should be kept separate like previous literature. They each have their own reliability (alpha = .87 for daughters and alpha = .70 for mothers) and should NOT be averaged over daughters and mothers. We therefore reported as separate by Daughters and Mothers.
|
40.6 units on a scale
STANDARD_DEVIATION 7.7 • n=59 Participants • Two separate scales: One from daughter's perspective and mother's perspective. They should be kept separate like previous literature. They each have their own reliability (alpha = .87 for daughters and alpha = .70 for mothers) and should NOT be averaged over daughters and mothers. We therefore reported as separate by Daughters and Mothers.
|
—
|
—
|
39.4 units on a scale
STANDARD_DEVIATION 8.4 • n=110 Participants • Two separate scales: One from daughter's perspective and mother's perspective. They should be kept separate like previous literature. They each have their own reliability (alpha = .87 for daughters and alpha = .70 for mothers) and should NOT be averaged over daughters and mothers. We therefore reported as separate by Daughters and Mothers.
|
|
Mother-Adolescent Communication: Open Family Communication
Mothers only
|
—
|
—
|
41.1 units on a scale
STANDARD_DEVIATION 5.2 • n=48 Participants • Two separate scales: One from daughter's perspective and mother's perspective. They should be kept separate like previous literature. They each have their own reliability (alpha = .87 for daughters and alpha = .70 for mothers) and should NOT be averaged over daughters and mothers. We therefore reported as separate by Daughters and Mothers.
|
41.2 units on a scale
STANDARD_DEVIATION 5.3 • n=54 Participants • Two separate scales: One from daughter's perspective and mother's perspective. They should be kept separate like previous literature. They each have their own reliability (alpha = .87 for daughters and alpha = .70 for mothers) and should NOT be averaged over daughters and mothers. We therefore reported as separate by Daughters and Mothers.
|
41.1 units on a scale
STANDARD_DEVIATION 5.3 • n=102 Participants • Two separate scales: One from daughter's perspective and mother's perspective. They should be kept separate like previous literature. They each have their own reliability (alpha = .87 for daughters and alpha = .70 for mothers) and should NOT be averaged over daughters and mothers. We therefore reported as separate by Daughters and Mothers.
|
|
Mother-Teen Sexual Risk Communication
|
24.5 units on a scale
STANDARD_DEVIATION 8.6 • n=51 Participants • This measure was only collected for daughters (n=110).
|
24.2 units on a scale
STANDARD_DEVIATION 9.1 • n=59 Participants • This measure was only collected for daughters (n=110).
|
—
|
—
|
24.4 units on a scale
STANDARD_DEVIATION 8.8 • n=110 Participants • This measure was only collected for daughters (n=110).
|
|
HIV Knowledge
|
9.9 units on a scale
STANDARD_DEVIATION 2.5 • n=51 Participants • This measure was only collected for daughters (n=110).
|
9.1 units on a scale
STANDARD_DEVIATION 3.2 • n=59 Participants • This measure was only collected for daughters (n=110).
|
—
|
—
|
9.5 units on a scale
STANDARD_DEVIATION 2.9 • n=110 Participants • This measure was only collected for daughters (n=110).
|
|
Maternal Bond Scale
|
26.3 units on a scale
STANDARD_DEVIATION 5.9 • n=51 Participants • This measure was only collected for daughters (n=110).
|
27.9 units on a scale
STANDARD_DEVIATION 4.5 • n=59 Participants • This measure was only collected for daughters (n=110).
|
—
|
—
|
27.2 units on a scale
STANDARD_DEVIATION 5.2 • n=110 Participants • This measure was only collected for daughters (n=110).
|
|
Rosenberg Self-Esteem
|
21.0 units on a scale
STANDARD_DEVIATION 5.9 • n=51 Participants • This measure was only collected for daughters (n=110).
|
21.8 units on a scale
STANDARD_DEVIATION 4.2 • n=59 Participants • This measure was only collected for daughters (n=110).
|
—
|
—
|
21.5 units on a scale
STANDARD_DEVIATION 5.0 • n=110 Participants • This measure was only collected for daughters (n=110).
|
|
Sexual Assertiveness: Refusal subscale
|
23.3 units on a scale
STANDARD_DEVIATION 5.2 • n=51 Participants • This measure was only collected for daughters (n=110).
|
23.9 units on a scale
STANDARD_DEVIATION 4.9 • n=59 Participants • This measure was only collected for daughters (n=110).
|
—
|
—
|
23.6 units on a scale
STANDARD_DEVIATION 5.0 • n=110 Participants • This measure was only collected for daughters (n=110).
|
|
Sexual Assertiveness: Prevent subscale
|
27.0 units on a scale
STANDARD_DEVIATION 4.3 • n=51 Participants • This measure was only collected for daughters (n=110).
|
25.5 units on a scale
STANDARD_DEVIATION 4.9 • n=59 Participants • This measure was only collected for daughters (n=110).
|
—
|
—
|
26.2 units on a scale
STANDARD_DEVIATION 4.7 • n=110 Participants • This measure was only collected for daughters (n=110).
|
|
Empowerment: Interpersonal
|
9.4 units on a scale
STANDARD_DEVIATION 2.2 • n=51 Participants • This measure was only collected for daughters (n=110).
|
9.2 units on a scale
STANDARD_DEVIATION 2.6 • n=59 Participants • This measure was only collected for daughters (n=110).
|
—
|
—
|
9.3 units on a scale
STANDARD_DEVIATION 2.4 • n=110 Participants • This measure was only collected for daughters (n=110).
|
|
Empowerment: Relationship
|
8.0 units on a scale
STANDARD_DEVIATION 4.0 • n=51 Participants • This measure was only collected for daughters (n=110).
|
7.9 units on a scale
STANDARD_DEVIATION 3.8 • n=59 Participants • This measure was only collected for daughters (n=110).
|
—
|
—
|
8.0 units on a scale
STANDARD_DEVIATION 3.9 • n=110 Participants • This measure was only collected for daughters (n=110).
|
|
Empowerment: Personal
|
18.5 units on a scale
STANDARD_DEVIATION 2.6 • n=51 Participants • This measure was only collected for daughters (n=110).
|
18.2 units on a scale
STANDARD_DEVIATION 4.2 • n=59 Participants • This measure was only collected for daughters (n=110).
|
—
|
—
|
18.4 units on a scale
STANDARD_DEVIATION 3.5 • n=110 Participants • This measure was only collected for daughters (n=110).
|
|
Adolescent Sexual Activity Index
|
1.5 units on a scale
STANDARD_DEVIATION 1.6 • n=51 Participants • This measure was only collected for daughters (n=110).
|
1.5 units on a scale
STANDARD_DEVIATION 1.6 • n=59 Participants • This measure was only collected for daughters (n=110).
|
—
|
—
|
1.5 units on a scale
STANDARD_DEVIATION 1.7 • n=110 Participants • This measure was only collected for daughters (n=110).
|
|
Any sex no condom, past 3 months
|
4 Participants
n=51 Participants • This measure was only collected for daughters (n=110).
|
1 Participants
n=59 Participants • This measure was only collected for daughters (n=110).
|
—
|
—
|
5 Participants
n=110 Participants • This measure was only collected for daughters (n=110).
|
|
Sex with multiple partners, ever
|
1 Participants
n=51 Participants • This measure was only collected for daughters (n=110).
|
2 Participants
n=59 Participants • This measure was only collected for daughters (n=110).
|
—
|
—
|
3 Participants
n=110 Participants • This measure was only collected for daughters (n=110).
|
|
Drugs/Alcohol use during sex, past 3 months
|
2 Participants
n=51 Participants • This measure was only collected for daughters (n=110).
|
0 Participants
n=59 Participants • This measure was only collected for daughters (n=110).
|
—
|
—
|
2 Participants
n=110 Participants • This measure was only collected for daughters (n=110).
|
|
Communication about Sex Self-Efficacy
|
—
|
—
|
55.8 units on a scale
STANDARD_DEVIATION 5.3 • n=48 Participants • This measure was only collected for mothers (n=102).
|
55.8 units on a scale
STANDARD_DEVIATION 5.2 • n=54 Participants • This measure was only collected for mothers (n=102).
|
55.8 units on a scale
STANDARD_DEVIATION 5.2 • n=102 Participants • This measure was only collected for mothers (n=102).
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Adolescent Sexual Activity Index (Female). The theoretical minimum and maximum values are min=0 and max=10 (Hansen, Paskett, \& Carter, 1999). A higher index value indicates more activity (worse outcome).
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Adolescent Sexual Activity Index
Baseline / Pre-Interveniton
|
1.39 score on a scale
Standard Error .19
|
1.45 score on a scale
Standard Error .19
|
|
Adolescent Sexual Activity Index
At 12 months
|
2.12 score on a scale
Standard Error .33
|
1.90 score on a scale
Standard Error .30
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Any sex no condom, past 3 months
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Any Sex no Condom, Past 3 Months
Baseline / Pre-Interveniton
|
7.1 logistic GEE predicted probability as %
Standard Error 3.6
|
1.3 logistic GEE predicted probability as %
Standard Error 1.3
|
|
Any Sex no Condom, Past 3 Months
At 12 months
|
8.4 logistic GEE predicted probability as %
Standard Error 4.3
|
2.4 logistic GEE predicted probability as %
Standard Error 1.7
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Sex with multiple partners, ever
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Sex With Multiple Partners, Ever
Baseline / Pre-Interveniton
|
0.0 logistic GEE predicted probability as %
Standard Error 0.0
|
0.0 logistic GEE predicted probability as %
Standard Error 0.0
|
|
Sex With Multiple Partners, Ever
At 12 months
|
1.0 logistic GEE predicted probability as %
Standard Error 0.9
|
2.2 logistic GEE predicted probability as %
Standard Error 1.3
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Drugs/Alcohol use during sex, past 3 months
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Drugs/Alcohol Use During Sex, Past 3 Months
Baseline / Pre-Interveniton
|
4.4 logistic GEE predicted probability as %
Standard Error 3.2
|
0.0 logistic GEE predicted probability as %
Standard Error 0.0
|
|
Drugs/Alcohol Use During Sex, Past 3 Months
At 12 months
|
1.3 logistic GEE predicted probability as %
Standard Error 1.4
|
5.1 logistic GEE predicted probability as %
Standard Error 3.7
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
HIV-Knowledge Questionnaire for Adolescent Girls. The theoretical minimum and maximum values are min=0 and max=18. Higher scores indicate higher HIV knowledge which is a better outcome.
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
HIV Knowledge
Baseline / Pre-Interveniton
|
9.8 score on a scale
Standard Error 0.31
|
8.5 score on a scale
Standard Error 0.56
|
|
HIV Knowledge
At 12 months
|
13.1 score on a scale
Standard Error 0.38
|
10.4 score on a scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Maternal Bond Scale. The theoretical minimum and maximum are min=8 to max=40. Higher scores indicate stronger maternal bonds which is a better outcome.
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Maternal Bond Scale
Baseline / Pre-Interveniton
|
26.9 score on a scale
Standard Error 0.78
|
27.8 score on a scale
Standard Error 0.62
|
|
Maternal Bond Scale
At 12 months
|
26.8 score on a scale
Standard Error 0.63
|
28.9 score on a scale
Standard Error 0.65
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Mother-Teen Sexual Risk Communication. The theoretical minimum and maximum are min=8 to max=40. Higher scores indicate greater mother-teen communication about sexual risk which is a better outcome.
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Mother-Teen Sexual Risk Communication
Baseline / Pre-Interveniton
|
22.8 score on a scale
Standard Error 1.4
|
22.0 score on a scale
Standard Error 1.6
|
|
Mother-Teen Sexual Risk Communication
At 12 months
|
25.4 score on a scale
Standard Error 1.1
|
26.1 score on a scale
Standard Error 1.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Mother-Adolescent Communication: Open Family Communication (Girl). The theoretical minimum and maximum values are min=10 and max=50. A higher value indicates greater mother-adolescent open family communication which is a better outcome.
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Mother-Adolescent Communication: Open Family Communication (Girl)
Baseline / Pre-Interveniton
|
39.1 score on a scale
Standard Error 1.1
|
39.5 score on a scale
Standard Error 1.6
|
|
Mother-Adolescent Communication: Open Family Communication (Girl)
At 12 months
|
37.8 score on a scale
Standard Error 1.3
|
39.2 score on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Maternal Monitoring Scale (Girl). The theoretical minimum and maximum values are min=8 and max=40. A higher value indicates greater maternal monitoring which is a better outcome.
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Maternal Monitoring Scale (Girl)
Baseline / Pre-Interveniton
|
34.4 score on a scale
Standard Error 0.76
|
35.0 score on a scale
Standard Error 0.50
|
|
Maternal Monitoring Scale (Girl)
At 12 months
|
34.7 score on a scale
Standard Error 0.67
|
35.1 score on a scale
Standard Error 0.78
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Rosenberg Self-Esteem Scale. The theoretical minimum and maximum values are min=10 and max=40. A higher value indicates higher self-esteem which is a better outcome.
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Rosenberg Self-Esteem
Baseline / Pre-Interveniton
|
20.6 score on a scale
Standard Error 0.88
|
21.7 score on a scale
Standard Error 0.64
|
|
Rosenberg Self-Esteem
At 12 months
|
21.8 score on a scale
Standard Error 1.0
|
22.8 score on a scale
Standard Error 0.90
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Racial Pride Scale. The theoretical minimum and maximum values are min=7 and max=28. A higher value indicates stronger feelings of racial pride which is a better outcome.
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Racial Pride
Baseline / Pre-Interveniton
|
20.9 score on a scale
Standard Error 0.71
|
21.2 score on a scale
Standard Error 0.54
|
|
Racial Pride
At 12 months
|
22.7 score on a scale
Standard Error 0.52
|
22.3 score on a scale
Standard Error 0.56
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=4 and max=20. A higher value indicates greater personal influence on relationship decisions.
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Empowerment: Interpersonal
Baseline / Pre-Interveniton
|
14.7 score on a scale
Standard Error 0.32
|
14.8 score on a scale
Standard Error 0.36
|
|
Empowerment: Interpersonal
At 12 months
|
14.2 score on a scale
Standard Error 0.35
|
15.2 score on a scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater influence over a partner.
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Empowerment: Relationship
At 12 months
|
17.1 score on a scale
Standard Error 0.52
|
16.6 score on a scale
Standard Error 0.51
|
|
Empowerment: Relationship
Baseline / Pre-Intervention
|
16.0 score on a scale
Standard Error 0.56
|
15.0 score on a scale
Standard Error 0.66
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Empowerment Scale: Personal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater personal empowerment.
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Empowerment: Personal
At 12 months
|
18.2 score on a scale
Standard Error 0.40
|
18.3 score on a scale
Standard Error 0.46
|
|
Empowerment: Personal
Baseline / Pre-Intervention
|
18.6 score on a scale
Standard Error 0.44
|
18.3 score on a scale
Standard Error 0.46
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Sexual Assertiveness Refusal subscale. The theoretical minimum and maximum scores are min=6 and max=30. Higher scores indicate greater assertiveness in refusing sexual activity (better outcome).
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Sexual Assertiveness: Refusal
Baseline / Pre-Interveniton
|
23.2 score on a scale
Standard Error 0.87
|
24.4 score on a scale
Standard Error 0.70
|
|
Sexual Assertiveness: Refusal
At 12 months
|
25.0 score on a scale
Standard Error 0.98
|
25.3 score on a scale
Standard Error 0.77
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.
Sexual Assertiveness Prevent subscale. The theoretical minimum and maximum scores are min=6 and max=30. Higher scores indicate greater assertiveness in taking measures to prevent pregnancy (better outcome).
Outcome measures
| Measure |
Risky Sex Prevention
n=51 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=59 Participants
General health education, activities
|
|---|---|---|
|
Sexual Assertiveness: Prevent
Baseline / Pre-Intervention
|
26.8 score on a scale
Standard Error 0.68
|
25.8 score on a scale
Standard Error 0.68
|
|
Sexual Assertiveness: Prevent
At 12 months
|
27.1 score on a scale
Standard Error 0.71
|
26.4 score on a scale
Standard Error 0.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=48 mothers for Risky sex prevention and n=54 mothers for Health behaviors.
Mother Adolescent Communication: Open Family Communication (Mother). The theoretical minimum and maximum values are min=10 and max=50. A higher value indicates greater mother-adolescent open family communication which is a better outcome.
Outcome measures
| Measure |
Risky Sex Prevention
n=48 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=54 Participants
General health education, activities
|
|---|---|---|
|
Mother Adolescent Communication: Open Family Communication (Mother)
Baseline / Pre-Interveniton
|
41.4 score on a scale
Standard Error 0.80
|
41.2 score on a scale
Standard Error 0.76
|
|
Mother Adolescent Communication: Open Family Communication (Mother)
At 12 months
|
41.0 score on a scale
Standard Error 0.93
|
41.5 score on a scale
Standard Error 0.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=48 mothers for Risky sex prevention and n=54 mothers for Health behaviors.
Maternal Monitoring Scale (Mother). The theoretical minimum and maximum values are min=8 and max=40. A higher value indicates greater maternal monitoring which is a better outcome.
Outcome measures
| Measure |
Risky Sex Prevention
n=48 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=54 Participants
General health education, activities
|
|---|---|---|
|
Maternal Monitoring Scale (Mother)
Baseline / Pre-Interveniton
|
37.1 score on a scale
Standard Error 0.44
|
37.3 score on a scale
Standard Error 0.35
|
|
Maternal Monitoring Scale (Mother)
At 12 months
|
37.9 score on a scale
Standard Error 0.29
|
37.4 score on a scale
Standard Error 0.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=48 mothers for Risky sex prevention and n=54 mothers for Health behaviors.
Communication about Sex Self-Efficacy Scale. The theoretical minimum and maximum scores are min=12 and max=60. Higher scores indicate greater self-efficacy (better outcome).
Outcome measures
| Measure |
Risky Sex Prevention
n=48 Participants
Education, activities, empowerment, racial pride building...
|
Healthy Behaviors
n=54 Participants
General health education, activities
|
|---|---|---|
|
Communication About Sex Self-Efficacy Scale
Baseline / Pre-Interveniton
|
56.0 score on a scale
Standard Error 0.74
|
55.5 score on a scale
Standard Error 0.92
|
|
Communication About Sex Self-Efficacy Scale
At 12 months
|
57.8 score on a scale
Standard Error 0.59
|
58.3 score on a scale
Standard Error 0.31
|
Adverse Events
Risky Sex Prevention-Daughters
Healthy Behaviors-Daughters
Risky Sex Prevention-Mothers
Healthy Behaviors-Mothers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lisa Goble Director Office of Research Integrity
UNC Greensboro
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place