Education Program to Reduce Risky Behavior in Adolescents Ph I
iTRAC
An Interactive Education Program to Reduce High Risk Behavior in Adolescents Ph I
2 other identifiers
observational
24
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2022
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2022
CompletedFirst Posted
Study publicly available on registry
November 7, 2022
CompletedStudy Start
First participant enrolled
November 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedSeptember 15, 2023
September 1, 2023
7 months
October 13, 2022
September 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Baseline, After wireframe production (approximately 2 months after baseline)
Study Arms (3)
Adolescent Advisory Board Male
This board consisted of 9 male adolescents recruited from the schools.
Adolescent Advisory Board Female
This board consisted of 9 female adolescents recruited from the schools.
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.
Interventions
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
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
Eligibility Criteria
The adolescent advisory board members and the health education professionals will be recruited from participating schools.
You may qualify if:
- Attending 7th grade
- Between 12 and 14 years old
- Parent/guardian speaks English or Spanish
- Attending participating school
You may not qualify if:
- Unable to read at a 4th grade level
- Have a sibling who has participated in the study
- Have a developmental disorder
- Work at participating schools
- Directly involved in the health of middle school students
- Adult (at least 18)
- Teachers not directly involved in the health of middle school students
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Klein Buendel, Inc.lead
- Rhode Island Hospitalcollaborator
- University of Oregoncollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
Study Sites (3)
Klein Buendel
Golden, Colorado, 80401, United States
University of Oregon
Eugene, Oregon, 97403, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher D Houck, PhD
Rhode Island Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2022
First Posted
November 7, 2022
Study Start
November 28, 2022
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
September 15, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- After analyses are completed for the aims of the study
- Access Criteria
- The data package will be available for future investigators. For datasets that include potentially sensitive information, investigators not part of the original study will submit requests to be reviewed by the PIs. Qualified investigators who agree to terms of use and confidentiality agreements will be provided with deidentified data.
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.