Clinical trial NCT03736876: A Healthy Relationships Program for Vulnerable Youth
Official title: About Us: A Healthy Relationships Program for Vulnerable Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy, Unplanned
Sexually Transmitted Diseases
Keywords: Youth
Adolescents
Teens
Healthy Relationships
Unintended Pregnancy
Teen Pregnancy
Sexually Transmitted Infections
Sexually Transmitted Diseases
Sexual Health Education
School-Based Health Center
Randomized Controlled Trial
Lead sponsor: ETR Associates
Sponsor class: OTHER
Collaborators: name: Family and Youth Services Bureau
name: San Diego State University
name: California School-Based Health Alliance
First posted: 2018-11-09
Enrollment: 550
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-site independent randomized group treatment trial (IGRT). 1,209 youth randomized to intervention or control conditions within schools. Sample accrues over 2.5 years (Years 2-4)
Primary purpose: PREVENTION

Brief summary: Developed from a piloted intervention and based on scientific evidence, About Us is an innovative healthy relationships intervention that promotes positive adolescent romantic relationships and use of condoms and highly effective contraceptives if having sex. The program includes 10 lessons (2 that are between 30-45 minutes long 8 that are 50 minutes long) that blend group-based activities with online activities implemented in a small group format with students in grades 9 or 10 who have parental consent and provide assent to take part. The program will be implemented in school-based health centers (SBHCs).

Primary research question:

1. Nine months following the end of the program, what is the impact of About Us relative to the standard of care on:

   1.1. Rates of vaginal or anal sex without condoms in the past three months?

   Secondary research questions:
2. Three and nine months following the end of the program, what is the impact of About Us relative to the standard of care on:

   2.1. Rates of abstinence from vaginal or anal sex in the past three months? 2.2. Frequency of communicating without abuse? 2.3. Utilization of school-based health center services? 2.4. Rates of behavioral willingness and attitudes toward birth control?

   Exploratory research questions:
3. Three and nine months following the end of the program, what is the impact of About Us relative to the standard of care on:

   3.1. The psychosocial variables stemming from the theoretical framework (e.g., attitudes toward condom and contraceptive use, normative beliefs, perceived self-efficacy to use condoms or have difficult conversations) and enumerated in the logic model.

   3.2. Outcomes listed above within key sub-groups including those defined by sex (male/female), race/ethnicity, and exposure to violence;
4. Among those receiving About Us, how do effect sizes for the primary and secondary behavioral outcomes vary by dosage?

Detailed description: Students will be screened for eligibility through each school-based health center (SBHC) by SBHC staff, and those participants meeting the screening eligibility requirements (previous exposure to violence and/or previous or current involvement in a romantic relationship) will be offered a parental consent form and informational packet. Consent forms will be available in English and Spanish. Pending parental consent and youth assent, students will be randomized into either the intervention or control group.

Eligibility criteria: Inclusion Criteria:

* The target population includes 9th or 10th grade students from participating schools who meet at least one of the following inclusion criteria based on their responses to a school-wide health assessment:

  1. prior exposure to violence;
  2. prior or current experience with a romantic relationship.

Any student answering "yes" to either criteria would be eligible to take part in the study. Only those who have parent consent and assent would be enrolled.

Exclusion Criteria:

* Those students without parental consent;
* If siblings are eligible to participate, the sibling who returns the signed consent form first will be admitted into the study. Any other eligible siblings will be excluded.

Primary outcomes:
measure: Rates of vaginal or anal sex without condoms
timeFrame: 9 months post intervention
Secondary outcomes:
measure: Rates of abstinence of vaginal or anal sex
timeFrame: 3 months post intervention
measure: Rates of abstinence of vaginal or anal sex
timeFrame: 9 months post intervention
measure: Frequency of communicating without abuse
timeFrame: 3 months post intervention
measure: Frequency of communicating without abuse
timeFrame: 9 months post intervention
measure: Clinic utilization
timeFrame: 3 months post intervention
measure: Clinic utilization
timeFrame: 9 months post intervention
measure: Behavioral intentions to engage in sexual activity
timeFrame: 3 months post intervention
measure: Behavioral intentions to engage in sexual activity
timeFrame: 9 months post intervention
measure: Behavioral intentions to use condoms
timeFrame: 3 months post intervention
measure: Behavioral intentions to use condoms
timeFrame: 9 months post intervention
Other outcomes:
Locations:
city: Oakland
country: United States
facility: California School Based Health Alliance
state: California
city: San Diego
country: United States
facility: San Diego State University
state: California
city: Scotts Valley
country: United States
facility: ETR
state: California
Study officials:
affiliation: ETR
name: Karin K Coyle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ETR
name: Pamela M Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson P, Coyle K, Guinosso S, Ferrand JL, Owora A, Houghton RF, Walsh-Buhi E. Promoting Adolescent Healthy Relationships (The About Us Program): Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2021 Sep 1;10(9):e30499. doi: 10.2196/30499.