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This study evaluates an educational web-based intervention designed to increase adolescent boys' and girls' motivation and skills to engage in safer sexual behavior (HEART: Health Education and Relationship Training). Half of participants will receive HEART and half of participants will receive Growing Minds, an attention-matched control website focused on growth mindsets of intelligence and self-regulation. The ultimate goal of this work is to help youth reduce their risk of HIV and other sexually transmitted diseases and to avoid unplanned pregnancies.
This study evaluates an educational web-based intervention designed to increase adolescent boys' and girls' motivation and skills to engage in safer sexual behavior (HEART: Health Education and Relationship Training). Half of participants will receive HEART and half of participants will receive Growing Minds, an attention-matched control website focused on growth mindsets of intelligence and self-regulation. The ultimate goal of this work is to help youth reduce their risk of HIV and other sexually transmitted diseases and to avoid unplanned pregnancies.
Primary outcomes for this study include 1) acceptability of the program, 2) safer sex self-efficacy, and 3) safer sex intentions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEART | Experimental | Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete. |
|
| Growing Minds | Other | Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEART | Behavioral | Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | 6-item self-report of program acceptability. Each item analyzed separately for the percentage endorsement. Items were as follows: Liked the program Learned new things Program kept attention Will use information in the future Useful for girls my age Useful for boys my age Below we report results for the first item: number of participants who agree that they like the program | immediate post-test at completion of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| HIV/STD Knowledge | HIV/STD knowledge was assessed with 9 items (e.g., "STDs usually have noticeable symptoms, like itching or burning"). These were adapted from previous sexual health knowledge questionnaires (Brown, DiClemente, & Park, 1992; Morton, Nelson, Walsh, Zimmerman, & Coe, 1996) and were used in our previous work (Widman, Golin, et al., 2018). Participants rated each item as True, False, or Don't Know. Responses were recoded as 0 (Incorrect or Don't Know) or 1 (Correct). Scores were summed to reflect the total number of correct HIV/STD knowledge questions (possible range=0-9). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Widman, PhD | North Carolina State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Carolina State University | Raleigh | North Carolina | 27695 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | HEART | Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete. HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. |
| FG001 | Growing Minds | Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete. Growing Minds: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HEART | Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete. HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. |
| 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 | Acceptability | 6-item self-report of program acceptability. Each item analyzed separately for the percentage endorsement. Items were as follows: Liked the program Learned new things Program kept attention Will use information in the future Useful for girls my age Useful for boys my age Below we report results for the first item: number of participants who agree that they like the program | 7 participants from HEART and 15 participants from Growing Minds did not complete the acceptability questionnaire. | Posted | Count of Participants | Participants | immediate post-test at completion of intervention |
|
1 yr
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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 | HEART | Interactive website with five modules to address safer sex motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. Program takes approximately 30-45 minutes to complete. HEART: Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laura Widman | North Carolina State University | 919-513-2546 | lmwidman@ncsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2019 | Oct 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Growing Minds | Behavioral | Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary. |
|
| immediate post-test at completion of intervention |
| Condom Beliefs | Participants' attitudes about condoms were assessed with the 3-item Effect on Sexual Experiences subscale of the Condom Attitudes Scale Adolescent Version (St. Lawrence et al., 1994). An example item includes, "Condoms take away the pleasure of sex." Responses were on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree; alpha=.77). A mean of the three items was computed, such that higher scores indicate better outcomes (possible range 1-5). | immediate post-test at completion of intervention |
| Sexual Assertiveness | Self-reported sexual assertiveness was assessed with 3-items from the Multidimensional Sexual Self-Concept Scale (Snell, 1998). Items such as, "I'm very assertive about the sexual aspects of my life," were rated on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree; alpha=.75). A mean of the three items was computed, such that higher scores indicate better outcomes (possible range 1-5). | immediate post-test at completion of intervention |
| Safer Sex Intentions | Intentions to discuss sexual health was assessed with a item developed by our research team based on items from the AIDS Risk Behavior Survey (Donenberg, Emerson, Bryant, Wilson, & Weber-Shifrin, 2001) and our previous work (Widman, Golin, et al., 2018). This item asked how likely teens were to discuss sexual health issues, including pregnancy and STDs, with their partner(s) prior to sexual activity (communication intentions). Response options ranged from 1 (not at all likely) to 5 (very likely). Higher scores indicate better outcomes. | immediate post-test at completion of intervention |
| Safer Sex Self-Efficacy | The Self-Efficacy for HIV Prevention Scale (Brown et al., 2014) was used to assess self-efficacy about communication and condom use. Six items assessed confidence communicating about sexual topics (e.g., "How sure are you that you could talk to your partner about safer sex?"). Two items assessed confidence obtaining and using condoms (e.g., "How sure are you that you could have condoms available when you need them?"). Participants responded from 1 (Couldn't do it) to 4 (Very Sure). A mean of all items was computed, such that higher scores indicate better outcomes (possible range 1-4; alpha=.79). | immediate post-test at completion of intervention |
| BG001 |
| Growing Minds |
Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete. Growing Minds: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Free/reduced price lunch | Count of Participants | Participants |
|
| OG001 | Growing Minds | Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete. Growing Minds: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary. |
|
|
| Secondary | HIV/STD Knowledge | HIV/STD knowledge was assessed with 9 items (e.g., "STDs usually have noticeable symptoms, like itching or burning"). These were adapted from previous sexual health knowledge questionnaires (Brown, DiClemente, & Park, 1992; Morton, Nelson, Walsh, Zimmerman, & Coe, 1996) and were used in our previous work (Widman, Golin, et al., 2018). Participants rated each item as True, False, or Don't Know. Responses were recoded as 0 (Incorrect or Don't Know) or 1 (Correct). Scores were summed to reflect the total number of correct HIV/STD knowledge questions (possible range=0-9). | 6 participants from HEART and 13 participants from Growing Minds did not complete the HIV/STD knowledge scale at post-test | Posted | Mean | Standard Deviation | units on a scale | immediate post-test at completion of intervention |
|
|
|
| Secondary | Condom Beliefs | Participants' attitudes about condoms were assessed with the 3-item Effect on Sexual Experiences subscale of the Condom Attitudes Scale Adolescent Version (St. Lawrence et al., 1994). An example item includes, "Condoms take away the pleasure of sex." Responses were on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree; alpha=.77). A mean of the three items was computed, such that higher scores indicate better outcomes (possible range 1-5). | 6 participants from HEART and 13 participants from Growing Minds did not complete the condom beliefs scale at post-test | Posted | Mean | Standard Deviation | units on a scale | immediate post-test at completion of intervention |
|
|
|
| Secondary | Sexual Assertiveness | Self-reported sexual assertiveness was assessed with 3-items from the Multidimensional Sexual Self-Concept Scale (Snell, 1998). Items such as, "I'm very assertive about the sexual aspects of my life," were rated on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree; alpha=.75). A mean of the three items was computed, such that higher scores indicate better outcomes (possible range 1-5). | 6 participants from HEART and 13 participants from Growing Minds did not complete the sexual assertiveness scale at post-test | Posted | Mean | Standard Deviation | units on a scale | immediate post-test at completion of intervention |
|
|
|
| Secondary | Safer Sex Intentions | Intentions to discuss sexual health was assessed with a item developed by our research team based on items from the AIDS Risk Behavior Survey (Donenberg, Emerson, Bryant, Wilson, & Weber-Shifrin, 2001) and our previous work (Widman, Golin, et al., 2018). This item asked how likely teens were to discuss sexual health issues, including pregnancy and STDs, with their partner(s) prior to sexual activity (communication intentions). Response options ranged from 1 (not at all likely) to 5 (very likely). Higher scores indicate better outcomes. | 6 participants from HEART and 13 participants from Growing Minds did not complete the safer sex intentions item at post-test | Posted | Mean | Standard Deviation | units on a scale | immediate post-test at completion of intervention |
|
|
|
| Secondary | Safer Sex Self-Efficacy | The Self-Efficacy for HIV Prevention Scale (Brown et al., 2014) was used to assess self-efficacy about communication and condom use. Six items assessed confidence communicating about sexual topics (e.g., "How sure are you that you could talk to your partner about safer sex?"). Two items assessed confidence obtaining and using condoms (e.g., "How sure are you that you could have condoms available when you need them?"). Participants responded from 1 (Couldn't do it) to 4 (Very Sure). A mean of all items was computed, such that higher scores indicate better outcomes (possible range 1-4; alpha=.79). | 6 participants from HEART and 13 participants from Growing Minds did not complete the safer sex self-efficacy scale item at post-test | Posted | Mean | Standard Deviation | units on a scale | immediate post-test at completion of intervention |
|
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|
| 0 |
| 113 |
| 0 |
| 113 |
| 0 |
| 113 |
| EG001 | Growing Minds | Attention-matched control website with five modules to address an introduction to mindsets, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and an integrative summary. Program takes approximately 30-45 minutes to complete. Growing Minds: Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary. | 0 | 113 | 0 | 113 | 0 | 113 |
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| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |