Risky Sexual BehavioriTRACNCT05607784
Education Program to Reduce Risky Behavior in Adolescents Ph I
An observational study of Risky Sexual Behavior and Emotional Regulation, run by Klein Buendel, Inc. at 3 sites in United States.
Trial summary
This phase will complete the TRAC adaptation to a web app. The pilot study (R21 HD089979) effectively translated the ER content of TRAC and the same procedures will be used to translate the remaining content. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Risky Sexual Behavior, Emotional Regulation, Adolescent Behavior
- What is being tested?
- Formative Research- Content Translation and Formative Research- Content Feedback and Acceptability
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Nov 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The adolescent advisory board members and the health education professionals will be recruited from participating schools.
Who may be able to join
- Attending 7th grade
- Between 12 and 14 years old
- Parent/guardian speaks English or Spanish
- Attending participating school
- Work at participating schools
- Directly involved in the health of middle school students
- Adult (at least 18)
Who cannot join
- Unable to read at a 4th grade level
- Have a sibling who has participated in the study
- Have a developmental disorder
- Teachers not directly involved in the health of middle school students
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Oregon
Eugene, Oregon, 97403
Klein Buendel
Golden, Colorado, 80401
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: An Interactive Education Program to Reduce High Risk Behavior in Adolescents Ph I
This phase will complete the TRAC adaptation to a web app. The pilot study (R21 HD089979) effectively translated the ER content of TRAC and the same procedures will be used to translate the remaining content.
Read the detailed description
Adolescence is a critical developmental period during which behavioral patterns are formed that have powerful influences on current and future health. This is particularly true for sexual behavior, which is affected by the bio-logical changes of puberty as well as normative developmental tasks around sexual exploration. Engaging in sexual behavior in early adolescence (before age 15) is associated with more partners, less condom use, and more frequent sex as teens get older, and these factors increase risk for negative health outcomes (e.g., sexually transmitted infections and unplanned pregnancy) throughout their lives. Many sexual health interventions teach prevention skills, such as assertiveness or condom use; the premise of the current application is that these skills are often unused by adolescents because of deficits in emotion regulation (ER), which is un-addressed in most sexual health education. The research team has developed and tested a novel, engaging, efficacious, and developmentally tailored group intervention (Project TRAC) to teach ER skills to early adolescents within the context of sexual health. A study of Project TRAC showed that participants taught ER skills were less likely to start having sex over the 2.5 year follow up. While efficacious, the small group format of the program presents barriers to sustainability and dissemination; significant advantages of web-based delivery exist. To explore whether the ER concepts of TRAC could be taught in a web-based format, the investigators completed a pilot study to translate TRAC's ER content to a web-based intervention (iTRAC), using Designing for Dissemination principles that enhance the likelihood of successful dissemination upon completion. iTRAC demonstrated feasibility and acceptability, and a randomized trial showed that iTRAC participants reported significantly better emotional competence compared to waitlist control participants. The proposed Fast Track project will complete the technology adaptation of the program to include its sexual health content and content linking ER to sexual health. This adaptation (iTRAC for Sexual Risk Prevention; iTRAC-SRP), using well-established theoretical frameworks, will be approached with advisory boards of school professionals and early adolescents, leading to prototypes of the completed intervention in Phase 1.
- Being tested
- Formative Research- Content Translation, Formative Research- Content Feedback and Acceptability
- Medical subject headings
- Emotional Regulation, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formative Research- Content TranslationBehavioural
This formative research includes brainstorming translation of content and reviewing wireframe prototypes generated from this process. It also includes attending to cultural, developmental, and gender considerations.
The design development cycles will begin with advisory focus group feedback about how the existing activities convey the content (i.e., what and how they are learning). They will advise on activity design for the remaining content (sexual health and content connecting this with ER) to ensure these are engaging, appropriate, and informative. They will also provide perspectives about design, structure, navigability, and approach
Formative Research- Content Feedback and AcceptabilityBehavioural
This formative research includes providing feedback on the proposed content and ensure contextual acceptability in schools.
The design development cycles will begin with advisory focus group feedback about how the existing activities convey the content (i.e., what and how they are learning). They will advise on activity design for the remaining content (sexual health and content connecting this with ER) to ensure these are engaging, appropriate, and informative. They will also provide perspectives about design, structure, navigability, and approach
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Advisory Board Male | This board consisted of 9 male adolescents recruited from the schools. Receives: Behavioral: Formative Research- Content Translation | |
| Adolescent Advisory Board Female | This board consisted of 9 female adolescents recruited from the schools. Receives: Behavioral: Formative Research- Content Translation | |
| Health Education Professionals Panel (HEPP) | This panel consisted of 6 health teachers and other school health professionals such as nurses and counselors. They were recruited at each participating school. Receives: Behavioral: Formative Research- Content Feedback and Acceptability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Formative Research
Advisory Focus Groups: Research summaries will also be generated to communicate with participating communities. Using these recommended D4D processes, the research will be better positioned for dissemination (and commercialization)
Measured: Baseline, After wireframe production (approximately 2 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start28 Nov 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risky Sexual BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rhode Island Hospital, University of Oregon, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Christopher D Houck, PhD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607784
- Sponsor's protocol ID
- 0342
- Other IDs
- 1R42HD110333-01
- Acronym
- iTRAC
- Status last verified
- Sep 2023
- First submitted
- 13 Oct 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will prepare an archival-quality data package for upload to the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH). Specifically, the investigators will provide documentation on the full data-audit trail from the exact prompts seen by participants, to the syntax used to score and aggregate items, to the finalized data ready for use by qualified investigators. The archival-quality data package will also include a codebook in line with the Data Documentation Initiative (DDI) and contains information about variables, metadata, and file structure. The metadata will include description of the trial, including design, implementation, and description of the interventions. The intent is to provide everything that future investigators require to understand the trial, analyze the data, correctly interpret the findings, and be able to publish new analyses that meet current publication standards for clinical trials and/or meta-analyses.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interactive Education Program to Reduce High Risk Behavior in Adolescents Ph I
- ClinicalTrials.gov ID
- NCT05607784
- Acronym / sponsor ID
- iTRAC / 0342
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rhode Island Hospital, University of Oregon, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase will complete the TRAC adaptation to a web app. The pilot study (R21 HD089979) effectively translated the ER content of TRAC and the same procedures will be used to translate the remaining content.
Detailed description
Adolescence is a critical developmental period during which behavioral patterns are formed that have powerful influences on current and future health. This is particularly true for sexual behavior, which is affected by the bio-logical changes of puberty as well as normative developmental tasks around sexual exploration. Engaging in sexual behavior in early adolescence (before age 15) is associated with more partners, less condom use, and more frequent sex as teens get older, and these factors increase risk for negative health outcomes (e.g., sexually transmitted infections and unplanned pregnancy) throughout their lives. Many sexual health interventions teach prevention skills, such as assertiveness or condom use; the premise of the current application is that these skills are often unused by adolescents because of deficits in emotion regulation (ER), which is un-addressed in most sexual health education. The research team has developed and tested a novel, engaging, efficacious, and developmentally tailored group intervention (Project TRAC) to teach ER skills to early adolescents within the context of sexual health. A study of Project TRAC showed that participants taught ER skills were less likely to start having sex over the 2.5 year follow up. While efficacious, the small group format of the program presents barriers to sustainability and dissemination; significant advantages of web-based delivery exist. To explore whether the ER concepts of TRAC could be taught in a web-based format, the investigators completed a pilot study to translate TRAC's ER content to a web-based intervention (iTRAC), using Designing for Dissemination principles that enhance the likelihood of successful dissemination upon completion. iTRAC demonstrated feasibility and acceptability, and a randomized trial showed that iTRAC participants reported significantly better emotional competence compared to waitlist control participants. The proposed Fast Track project will complete the technology adaptation of the program to include its sexual health content and content linking ER to sexual health. This adaptation (iTRAC for Sexual Risk Prevention; iTRAC-SRP), using well-established theoretical frameworks, will be approached with advisory boards of school professionals and early adolescents, leading to prototypes of the completed intervention in Phase 1.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adolescent Advisory Board Male | – | Behavioral: Formative Research- Content TranslationThis board consisted of 9 male adolescents recruited from the schools. |
| Adolescent Advisory Board Female | – | Behavioral: Formative Research- Content TranslationThis board consisted of 9 female adolescents recruited from the schools. |
| Health Education Professionals Panel (HEPP) | – | Behavioral: Formative Research- Content Feedback and AcceptabilityThis panel consisted of 6 health teachers and other school health professionals such as nurses and counselors. They were recruited at each participating school. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The adolescent advisory board members and the health education professionals will be recruited from participating schools.
Key inclusion criteria (7 listed)
- Attending 7th grade
- Between 12 and 14 years old
- Parent/guardian speaks English or Spanish
- Attending participating school
- Work at participating schools
Key exclusion criteria (4 listed)
- Unable to read at a 4th grade level
- Have a sibling who has participated in the study
- Have a developmental disorder
- Teachers not directly involved in the health of middle school students
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formative Research- Content TranslationThis formative research includes brainstorming translation of content and reviewing wireframe prototypes generated from this process. It also includes attending to cultural, developmental, and gender considerations. The design development cycles will begin with advisory focus group feedback about how the existing activities convey the content (i.e., what and how they are learning). They will advise on activity design for the remaining content (sexual health and content connecting this with ER) to ensure these are engaging, appropriate, and informative. They will also provide perspectives about design, structure, navigability, and approach | Behavioural | Adolescent Advisory Board Female, Adolescent Advisory Board Male |
| Formative Research- Content Feedback and AcceptabilityThis formative research includes providing feedback on the proposed content and ensure contextual acceptability in schools. The design development cycles will begin with advisory focus group feedback about how the existing activities convey the content (i.e., what and how they are learning). They will advise on activity design for the remaining content (sexual health and content connecting this with ER) to ensure these are engaging, appropriate, and informative. They will also provide perspectives about design, structure, navigability, and approach | Behavioural | Health Education Professionals Panel (HEPP) |
Primary outcome
Formative Research
Time frame: Baseline, After wireframe production (approximately 2 months after baseline)
Advisory Focus Groups: Research summaries will also be generated to communicate with participating communities. Using these recommended D4D processes, the research will be better positioned for dissemination (and commercialization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: Yes. The investigators will prepare an archival-quality data package for upload to the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH). Specifically, the investigators will provide documentation on the full data-audit trail from the exact prompts seen by participants, to the syntax used to score and aggregate items, to the finalized data ready for use by qualified investigators. The archival-quality data package will also include a codebook in line with the Data Documentation Initiative (DDI) and contains information about variables, metadata, and file structure. The metadata will include description of the trial, including design, implementation, and description of the interventions. The intent is to provide everything that future investigators require to understand the trial, analyze the data, correctly interpret the findings, and be able to publish new analyses that meet current publication standards for clinical trials and/or meta-analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher D Houck, PhD principal investigator
Rhode Island Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risky Sexual Behavior and Emotional Regulation, run by Klein Buendel, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Formative Research (time frame: Baseline, After wireframe production (approximately 2 months after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.