Adolescent Relationship AbuseH-REPNCT03519191
Healthy Relationships and Economic Pathways
A study testing Healthy Relationships Education (HRE) and HRE+Technology Bootcamp in people with Adolescent Relationship Abuse and Sexually Transmitted Infections, run by Public Health Institute, California at 1 site in United States.
Trial summary
The California Adolescent Health Collaborative (CAHC) brings together multiple nonprofit organizations in California's Central Valley to implement the Healthy Relationships and Economic Pathways (H-REP) program, which aims to increase and promote healthy relationships and stability among youth between the ages of 14… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Relationship Abuse, Sexually Transmitted Infections, Pregnancy (Unwanted)
- What is being tested?
- Healthy Relationships Education (HRE) and HRE+Technology Bootcamp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 1 Jul 2018
- Phase
- Interventional
- 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- students in traditional, comprehensive high schools; students in continuation or alternative schools; youth between ages of 18-24 who receive employment support services from Central Valley non-profit programs (California); residents of Merced or Stanislaus counties (California).
Who cannot join
- less than sixth-grade English language proficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Relationships and Economic Pathways Evaluation Study
The California Adolescent Health Collaborative (CAHC) brings together multiple nonprofit organizations in California's Central Valley to implement the Healthy Relationships and Economic Pathways (H-REP) program, which aims to increase and promote healthy relationships and stability among youth between the ages of 14 and 24.
Read the detailed description
This research project was designed to explore three core questions (RQs).
Research Question 1:Does assignment to the HRE improve the knowledge and skills necessary to develop and maintain caring and supportive personal and professional relationships among youth between the ages of 18 and 24 in Stanislaus and Merced Counties?
In addition, American Institutes for Research (AIR), an independent evaluator, has been asked to answer two supplemental RQs:
Research Question 2: Does participation in the HRE Technology Boot Camp improve technological knowledge and skills as well as awareness of professional and educational opportunities among youth between the ages of 18 and 24?
Research Question 3: Does HRE have the same effect on relationship knowledge and skills for youth between the ages of 18 and 24 who participate in the HRE-only training as it does for youth who participate in HRE plus Technology Bootcamp?
H-REP provides a comprehensive, three-pathway program of services to (a) students in traditional, comprehensive high schools; (b) students in continuation of alternative schools (e.g. court schools); and (c) youth between the ages of 18 and 24 who are receiving employment support services from Central Valley nonprofit programs. The H-REP program involves formal classes in Healthy Relationship Education (HRE) and technology use, case management, and job skills training.
- Conditions
- Adolescent Relationship Abuse, Sexually Transmitted Infections, Pregnancy (Unwanted), Violence, Intentional Injury
- Being tested
- Healthy Relationships Education (HRE), HRE+Technology Bootcamp
- Keywords
- teen dating violence, sexual assault, reproductive coercion
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Relationships Education (HRE)Behavioural
Healthy Relationships and Economic Pathways involves formal classes in Healthy Relationship Education (HRE), comprehensive case management, and support services and referrals to services.
HRE+Technology BootcampBehavioural
HRE + Technology Bootcamp involves formal classes in Healthy Relationships Education (HRE), comprehensive case management, support services and referral to services, 6-week intensive website and professional development training, and paid work experience developing a website for a local small business and mentorship.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Relationships Education (HRE) | Other | Social-behavioral intervention Participants will receive employment support services and Healthy Relationships Education interventions. Receives: Behavioral: Healthy Relationships Education (HRE) |
| HRE+Technology Bootcamp | Other | Social-behavioral intervention + technology bootcamp (associated economic pathways for participants) Participants will receive employment support services, Healthy Relationships Education, and Technology Bootcamp interventions. Receives: Behavioral: HRE+Technology Bootcamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRE survey to assess changes in knowledge and skills needed to develop and maintain caring and supportive personal and professional relationships (surveys)
Baseline and 6 month follow-up surveys of participants will be conducted to assess impact of the intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start1 Jun 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Why it stopped: Recruitment too low for power analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Relationship AbuseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This socio-behavioral intervention project will randomly assign participants to the HRE-only or the HRE+Technology bootcamp arms, with a waitlist for accommodation of additionally interested youth, and a cross-over option
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Institute, California
- Sponsor type
- University, hospital or other
- Collaborators
- American Institutes for Research
- Responsible party
- Sponsor
- Investigators
- Alison Chopel, DrPH, Principal investigator, Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519191
- Sponsor's protocol ID
- PHICalifornia
- Acronym
- H-REP
- Status last verified
- Sep 2019
- First submitted
- 6 Apr 2018
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Relationships and Economic Pathways Evaluation Study
- ClinicalTrials.gov ID
- NCT03519191
- Acronym / sponsor ID
- H-REP / PHICalifornia
- Conditions
- Adolescent Relationship Abuse, Sexually Transmitted Infections, Pregnancy (Unwanted), Violence, Intentional Injury
- Keywords
- teen dating violence, sexual assault, reproductive coercion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment too low for power analysis
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Public Health Institute, CaliforniaUniversity, hospital or other
- Collaborators
- American Institutes for Research
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 8 May 2018 (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.
The California Adolescent Health Collaborative (CAHC) brings together multiple nonprofit organizations in California's Central Valley to implement the Healthy Relationships and Economic Pathways (H-REP) program, which aims to increase and promote healthy relationships and stability among youth between the ages of 14 and 24.
Detailed description
This research project was designed to explore three core questions (RQs).
Research Question 1:Does assignment to the HRE improve the knowledge and skills necessary to develop and maintain caring and supportive personal and professional relationships among youth between the ages of 18 and 24 in Stanislaus and Merced Counties?
In addition, American Institutes for Research (AIR), an independent evaluator, has been asked to answer two supplemental RQs:
Research Question 2: Does participation in the HRE Technology Boot Camp improve technological knowledge and skills as well as awareness of professional and educational opportunities among youth between the ages of 18 and 24?
Research Question 3: Does HRE have the same effect on relationship knowledge and skills for youth between the ages of 18 and 24 who participate in the HRE-only training as it does for youth who participate in HRE plus Technology Bootcamp?
H-REP provides a comprehensive, three-pathway program of services to (a) students in traditional, comprehensive high schools; (b) students in continuation of alternative schools (e.g. court schools); and (c) youth between the ages of 18 and 24 who are receiving employment support services from Central Valley nonprofit programs. The H-REP program involves formal classes in Healthy Relationship Education (HRE) and technology use, case management, and job skills training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This socio-behavioral intervention project will randomly assign participants to the HRE-only or the HRE+Technology bootcamp arms, with a waitlist for accommodation of additionally interested youth, and a cross-over option
| Arm | Type | Receives |
|---|---|---|
| Healthy Relationships Education (HRE) | Other | Behavioral: Healthy Relationships Education (HRE)Social-behavioral intervention Participants will receive employment support services and Healthy Relationships Education interventions. |
| HRE+Technology Bootcamp | Other | Behavioral: HRE+Technology BootcampSocial-behavioral intervention + technology bootcamp (associated economic pathways for participants) Participants will receive employment support services, Healthy Relationships Education, and Technology Bootcamp interventions. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- students in traditional, comprehensive high schools; students in continuation or alternative schools; youth between ages of 18-24 who receive employment support services from Central Valley non-profit programs (California); residents of Merced or Stanislaus counties (California).
Key exclusion criteria (1 listed)
- less than sixth-grade English language proficiency
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 |
|---|---|---|
| Healthy Relationships Education (HRE)Healthy Relationships and Economic Pathways involves formal classes in Healthy Relationship Education (HRE), comprehensive case management, and support services and referrals to services. | Behavioural | Healthy Relationships Education (HRE) |
| HRE+Technology BootcampHRE + Technology Bootcamp involves formal classes in Healthy Relationships Education (HRE), comprehensive case management, support services and referral to services, 6-week intensive website and professional development training, and paid work experience developing a website for a local small business and mentorship. | Behavioural | HRE+Technology Bootcamp |
Primary outcome
HRE survey to assess changes in knowledge and skills needed to develop and maintain caring and supportive personal and professional relationships (surveys)
Time frame: 6 months
Baseline and 6 month follow-up surveys of participants will be conducted to assess impact of the intervention.
Results and safety
The study was stopped early (reason given: Recruitment too low for power analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
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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.
Alison Chopel, DrPH principal investigator
Public Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Relationships Education (HRE) and HRE+Technology Bootcamp in people with Adolescent Relationship Abuse and Sexually Transmitted Infections, run by Public Health Institute, California at 1 site 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Recruitment too low for power analysis). Results are not available in the source record.
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?
HRE survey to assess changes in knowledge and skills needed to develop and maintain caring and supportive personal and professional relationships (surveys) (time frame: 6 months). 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 13 Sep 2019.