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| ID | Type | Description | Link |
|---|---|---|---|
| P20MD002289 | U.S. NIH Grant/Contract | View source |
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African American adolescent females are more likely to have sex at an early age, to have older sex partners that have had multiple sexual experiences, and are less likely to use a condom than their white counterparts. Lack of sexual assertiveness is a factor in the risky sex behaviors of young African American women. African American girls at the greatest risk for contracting HIV are the ones that report that their partners could convince them to have sex and report trouble communicating their wishes related to sex. Thus far no intervention has addressed the disparate rate of HIV infection in young African American girls. This study is unique in promoting increases in racial pride as a component of empowerment to help African American girls self-protect against HIV. The study has the potential to empower young African American girls to delay sex initiation or reduce risky sex behaviors and thus reduce their risk of contracting HIV.
This is a longitudinal intervention study with a study condition intervention and a control condition intervention. Potential participants will be invited to a recruitment meeting. If they choose to participate, they will be asked to sign informed consent or assent. There are 4 data collections for moms and girls - 1 after recruitment but before the start of the intervention, 1 at the end of the intervention (after the girls 12 week intervention), 1 three months after the end of the intervention (about 6 months after recruitment), and the final data collection 9 months after the end of the intervention (about 12 months from recruitment). Girls are asked to attend 12 group intervention sessions of about 2 hours each, once weekly, and then a final termination session that is followed by a celebration session to which their mothers are invited and then an evaluation session. Moms are asked to participate in 3 one hour education sessions over the 12 weeks that their daughters are in the weekly sessions, the celebration with their daughters, and then their evaluation session. Moms will also be asked to give their daughter empowering messages 5-7 times/week and girls asked to receive them. Finally, moms will be asked to receive calls from the study team once per month or 1 year to be asked about the empowering messages they have been sending their daughters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risky sex prevention | Experimental | education, activities, empowerment, racial pride building |
|
| Healthy behaviors | Active Comparator | General health education, activities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education, activities, empowerment, racial pride building | Behavioral | Intervention focuses on information aimed toward reducing or preventing risky sex behaviors of minority adolescent females. |
| Measure | Description | Time Frame |
|---|---|---|
| Adolescent Sexual Activity Index | 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). | 12 months |
| Any Sex no Condom, Past 3 Months | Any sex no condom, past 3 months | 12 months |
| Sex With Multiple Partners, Ever | Sex with multiple partners, ever | 12 months |
| Drugs/Alcohol Use During Sex, Past 3 Months | Drugs/Alcohol use during sex, past 3 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Knowledge | 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. | 12 month |
| Maternal Bond Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Mother Adolescent Communication: Open Family Communication (Mother) | 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. | 12 months |
Mother Inclusion Criteria:
Mother Exclusion Criteria:
Daughter Inclusion Criteria:
Daughter Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracy R Bartlett, PhD | University of North Carolina, Greensboro | Principal Investigator |
| Debra C Wallace, PhD | Univeristy of North Carolina, Greensboro | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina, Greensboro | Greensboro | North Carolina | 27402 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23452110 | Background | Wallace DC, Bartlett R. Recruitment and retention of African American and Hispanic girls and women in research. Public Health Nurs. 2013 Mar;30(2):159-66. doi: 10.1111/phn.12014. Epub 2012 Nov 22. | |
| 29932539 | Result | Bartlett R, Johnson A, Randolph I, McCoy TP. Communication and Bonding Between African-American Middle School Girls and Their Maternal Figures. J Natl Black Nurses Assoc. 2016 Jul;27(1):18-23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Risky Sex Prevention-Daughters | Education, activities, empowerment, racial pride building... |
| FG001 | Healthy Behaviors-Daughters | General health education, activities |
| FG002 | Risky Sex Prevention-Mothers | Activities, empowerment, communication... |
| FG003 | Healthy Behaviors-Mothers | General health education, activities |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The overall number of baseline participants (212) is based on both daughters and mothers in all arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Risky Sex Prevention-Daughters | Education, activities, empowerment, racial pride building... |
| BG001 | Healthy Behaviors-Daughters | General health education, activities |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adolescent Sexual Activity Index | 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). | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Risky Sex Prevention-Daughters | education, activities, empowerment, racial pride building Education, activities, empowerment, racial pride building: Intervention focuses on information aimed toward reducing or preventing risky sex behaviors of minority adolescent females. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Goble Director Office of Research Integrity | UNC Greensboro | 336-256-1173 | lagoble@uncg.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 28, 2019 | May 14, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 27, 2019 | May 14, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D009043 | Motor Activity |
| D009068 | Movement |
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| General Health education, activities | Behavioral | Intervention focuses on information regarding general health knowledge and healthy behaviors (not including sex). |
|
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.
| 12 months |
| Mother-Teen Sexual Risk Communication | 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. | 12 months |
| Mother-Adolescent Communication: Open Family Communication (Girl) | 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. | 12 months |
| Maternal Monitoring Scale (Girl) | 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. | 12 months |
| Rosenberg Self-Esteem | 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. | 12 months |
| Racial Pride | 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. | 12 months |
| Empowerment: Interpersonal | 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. | 12 months |
| Empowerment: Relationship | Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater influence over a partner. | 12 months |
| Empowerment: Personal | Empowerment Scale: Personal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater personal empowerment. | 12 months |
| Sexual Assertiveness: Refusal | 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). | 12 months |
| Sexual Assertiveness: Prevent | 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). | 12 months |
| Maternal Monitoring Scale (Mother) |
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. |
| 12 months |
| Communication About Sex Self-Efficacy Scale | 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). | 12 months |
| BG002 | Risky Sex Prevention-Mothers | Activities, empowerment, communication..... |
| BG003 | Healthy Behaviors-Mothers | General health education, activities |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Current Grade | Only daughters (n=110) were analyzed for middle school grade. | Count of Participants | Participants |
|
| Racial Pride | This measure was not assessed for Mothers. | Mean | Standard Deviation | units on a scale |
|
| Maternal Monitoring Scale | There are two separate scales: One asked from the perspective of the daughter and one asked from the perspective of the mother. They should be kept separate as has previous literature. For example, they each have their own estimated scale reliability (alpha = .70 for daughters and alpha = .58 for mothers) and should NOT be averaged over daughters and mothers. | 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. | Mean | Standard Deviation | units on a scale |
|
| Mother-Adolescent Communication: Open Family Communication | There are two separate scales: One asked from the perspective of the daughter and one asked from the perspective of the mother. They should be kept separate as has previous literature. For example, they each have their own estimated scale reliability (alpha = .87 for daughters and alpha = .70 for mothers) and should NOT be averaged over daughters and mothers. We therefore reported as separate rows for Daughters only and Mothers only. | 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. | Mean | Standard Deviation | units on a scale |
|
| Mother-Teen Sexual Risk Communication | This measure was only collected for daughters (n=110). | Mean | Standard Deviation | units on a scale |
|
| HIV Knowledge | This measure was only collected for daughters (n=110). | Mean | Standard Deviation | units on a scale |
|
| Maternal Bond Scale | This measure was only collected for daughters (n=110). | Mean | Standard Deviation | units on a scale |
|
| Rosenberg Self-Esteem | This measure was only collected for daughters (n=110). | Mean | Standard Deviation | units on a scale |
|
| Sexual Assertiveness: Refusal subscale | This measure was only collected for daughters (n=110). | Mean | Standard Deviation | units on a scale |
|
| Sexual Assertiveness: Prevent subscale | This measure was only collected for daughters (n=110). | Mean | Standard Deviation | units on a scale |
|
| Empowerment: Interpersonal | This measure was only collected for daughters (n=110). | Mean | Standard Deviation | units on a scale |
|
| Empowerment: Relationship | This measure was only collected for daughters (n=110). | Mean | Standard Deviation | units on a scale |
|
| Empowerment: Personal | This measure was only collected for daughters (n=110). | Mean | Standard Deviation | units on a scale |
|
| Adolescent Sexual Activity Index | This measure was only collected for daughters (n=110). | Mean | Standard Deviation | units on a scale |
|
| Any sex no condom, past 3 months | This measure was only collected for daughters (n=110). | Count of Participants | Participants |
|
| Sex with multiple partners, ever | This measure was only collected for daughters (n=110). | Count of Participants | Participants |
|
| Drugs/Alcohol use during sex, past 3 months | This measure was only collected for daughters (n=110). | Count of Participants | Participants |
|
| Communication about Sex Self-Efficacy | 12 items; Cronbach's alpha = .78. | This measure was only collected for mothers (n=102). | Mean | Standard Deviation | units on a scale |
|
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| Primary | Any Sex no Condom, Past 3 Months | Any sex no condom, past 3 months | 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. | Posted | Least Squares Mean | Standard Error | logistic GEE predicted probability as % | 12 months |
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|
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| Primary | Sex With Multiple Partners, Ever | Sex with multiple partners, ever | 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. | Posted | Least Squares Mean | Standard Error | logistic GEE predicted probability as % | 12 months |
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| Primary | Drugs/Alcohol Use During Sex, Past 3 Months | Drugs/Alcohol use during sex, past 3 months | 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. | Posted | Least Squares Mean | Standard Error | logistic GEE predicted probability as % | 12 months |
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| Secondary | HIV Knowledge | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 month |
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| Secondary | Maternal Bond Scale | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
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| Secondary | Mother-Teen Sexual Risk Communication | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
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| Secondary | Mother-Adolescent Communication: Open Family Communication (Girl) | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
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| Secondary | Maternal Monitoring Scale (Girl) | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
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| Secondary | Rosenberg Self-Esteem | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
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| Secondary | Racial Pride | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
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| Secondary | Empowerment: Interpersonal | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
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| Secondary | Empowerment: Relationship | Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater influence over a partner. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
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| Secondary | Empowerment: Personal | Empowerment Scale: Personal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater personal empowerment. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
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| Secondary | Sexual Assertiveness: Refusal | 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). | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
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| Secondary | Sexual Assertiveness: Prevent | 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). | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
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| Other Pre-specified | Mother Adolescent Communication: Open Family Communication (Mother) | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
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| Other Pre-specified | Maternal Monitoring Scale (Mother) | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
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| Other Pre-specified | Communication About Sex Self-Efficacy Scale | 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). | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 12 months |
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| 0 |
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Healthy Behaviors-Daughters | General health education, activities General Health education, activities: Intervention focuses on information regarding general health knowledge and healthy behaviors (not including sex). | 0 | 59 | 0 | 59 | 0 | 59 |
| EG002 | Risky Sex Prevention-Mothers | Activities, empowerment | 0 | 48 | 0 | 48 | 0 | 48 |
| EG003 | Healthy Behaviors-Mothers | General health education, activities | 0 | 54 | 0 | 54 | 0 | 54 |
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| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Male |
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| Mixed |
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| Hispanic/Latino |
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| Other |
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| 8th grade |
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