Clinical trial NCT05087004: Planned Parenthood Teen Council Program Study
Official title: Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky Teen Council Program Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Problem Behavior
Keywords: Adolescent pregnancy prevention
Youth development
Lead sponsor: Philliber Research & Evaluation
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 810
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: Participating Planned Parenthood affiliates recruited teens to their Teen Council program each study year during the spring and summer months. Interested teens completed an application and, if after review they were deemed by the program to be good candidates, they were interviewed. Active consent was obtained from the parents or guardians of all eligible youth and teen assent was also collected. Twice as many qualified applicants as spots on each Teen Council were accepted and their names were submitted to Philliber for random assignment to the program or survey-only groups.
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial (RCT) evaluation of the Teen Council program that was tested with high school students (grades 10-12) to assess whether it results in a reduction of teen pregnancy among other outcomes.

Detailed description: Over the course of five years, we expected to have approximately 800 teens (400 program and 400 control) in the study. Teens were randomly selected for the program (Teen Council) and control (no program) conditions.

Teens in both groups were surveyed in the late summer/early fall of their enrollment year and each spring thereafter. Participation in the evaluation by control teens and unenrolled program teens was recognized with a small stipend.

The pre-survey was administered during the summer retreat for incoming Teen Council members. The same survey was administered by Philliber staff for the control youth via online, telephone, or mailed surveys during the late summer/fall. The post-surveys were administered at the end of the school year. Again, the survey was administered by program facilitators for the Teen Council program group. Philliber administered the post survey for the control group providing the same options for completion (online, telephone, or mail).

To facilitate follow-up, complete contact information was collected at baseline. This included the telephone numbers, physical addresses, and email addresses of the student and telephone numbers of their parents/guardians. Also requested was contact information for two relatives or adult friends who would likely know how to contact the teen. Parents were asked on the consent form to provide permission to receive change of school information in the event that their teen transferred to a new school. Philliber reached out to unenrolled Teen Council members and control group teens by telephone, email, text messaging, and/or U.S. Mail for survey administration (via telephone, online, or hard copy).

Eligibility criteria: Inclusion Criteria:

Applicants had to be:

1. entering 10th, 11th, or 12th grades;
2. able to attend an annual mandatory overnight retreat;
3. interested in providing accurate sexual health information to peers;
4. able to commit to weekly meetings;
5. able to miss school occasionally for presentations (one day per month);
6. responsible for budgeting their time and keeping up with their academic work.

Exclusion Criteria:

Any interested participant who did not meet all of the inclusion criteria:

1. was not entering 10th, 11th, or 12th grades;
2. was not able to attend an annual mandatory overnight retreat;
3. was not interested in providing accurate sexual health information to peers;
4. was not able to commit to weekly meetings;
5. was not able to miss school occasionally for presentations (one day per month); (6) was not responsible for budgeting their time and keeping up with their academic work.

Primary outcomes:
measure: Ever had sex
timeFrame: Prior to program participation (baseline)
measure: Ever had sex
timeFrame: 1 year
measure: Contraceptive use at last intercourse
timeFrame: Prior to program participation (baseline)
measure: Contraceptive use at last intercourse
timeFrame: 1 year
measure: Changes to contraceptive method in last year
timeFrame: Prior to program participation (baseline)
measure: Changes to contraceptive method in last year
timeFrame: 1 year
measure: Ever visited doctor/clinic for birth control, exam, or STI
timeFrame: Prior to program participation (baseline)
measure: Ever visited doctor/clinic for birth control, exam, or STI
timeFrame: 1 year
Secondary outcomes:
measure: Comfort with own sexuality scale
timeFrame: Prior to program participation (baseline)
measure: Comfort with own sexuality scale
timeFrame: 1 year
measure: Confidence in peer education skills scale
timeFrame: Prior to program participation (baseline)
measure: Confidence in peer education skills scale
timeFrame: 1 year
measure: Civic action scale
timeFrame: Prior to program participation (baseline)
measure: Civic action scale
timeFrame: 1 year
measure: Perspective taking scale
timeFrame: Prior to program participation (baseline)
measure: Perspective taking scale
timeFrame: 1 year
measure: Communication with parents
timeFrame: Prior to program participation (baseline)
measure: Communication with parents
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: