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Completed

NCT Number: NCT05087004

Planned Parenthood Teen Council Program Study

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.

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Key information

Conditions

Adolescent Problem Behavior

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Applicants had to be:

  • entering 10th, 11th, or 12th grades;
  • able to attend an annual mandatory overnight retreat;
  • interested in providing accurate sexual health information to peers;
  • able to commit to weekly meetings;
  • able to miss school occasionally for presentations (one day per month);
  • 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:

  • was not entering 10th, 11th, or 12th grades;
  • was not able to attend an annual mandatory overnight retreat;
  • was not interested in providing accurate sexual health information to peers;
  • was not able to commit to weekly meetings;
  • 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.

Treatment and study plan

Teen Council

Behavioral

Youth randomly selected for Teen Council attended weekly meetings for an entire school year to receive training on specific topics. In turn, they provided educational presentations to the community, which required that they miss school (about one day per month). The presentations Teen Council members offered in middle and high schools were most commonly on birth control methods; relationships; reproductive anatomy and physiology; sexual diversity; STDs/STIs; sexual consent; HIV/AIDS; and abstinence.

Primary outcomes

  1. Ever had sex

    Time frame: Prior to program participation (baseline)

    Study participants were asked, "Have you ever had sexual intercourse?" Sexual intercourse was defined as any oral, anal, or penis-in-vagina sex. Item response choices were Yes/No.

  2. Ever had sex

    Time frame: 1 year

    Study participants were asked, "Have you ever had sexual intercourse?" Sexual intercourse was defined as any oral, anal, or penis-in-vagina sex. Item response choices were Yes/No.

  3. Contraceptive use at last intercourse

    Time frame: Prior to program participation (baseline)

    Study participants were asked, "The last time you had sexual intercourse, which methods did you or your partner use to prevent pregnancy?" Item response options included: I have never had penis-in-vagina sexual intercourse; no method was used to prevent pregnancy; birth control pills; condoms; Depo-Provera (or any injectable birth control), Nuva Ring (or any birth control ring), Implanon (or any implant), birth control patch, or any IUD; withdrawal; some other method; and not sure. These responses were recoded to Yes/No.

  4. Contraceptive use at last intercourse

    Time frame: 1 year

    Study participants were asked, "The last time you had sexual intercourse, which methods did you or your partner use to prevent pregnancy?" Item response options included: I have never had penis-in-vagina sexual intercourse; no method was used to prevent pregnancy; birth control pills; condoms; Depo-Provera (or any injectable birth control), Nuva Ring (or any birth control ring), Implanon (or any implant), birth control patch, or any IUD; withdrawal; some other method; and not sure. These responses were recoded to Yes/No.

  5. Changes to contraceptive method in last year

    Time frame: Prior to program participation (baseline)

    Study participants were asked, "During the last year, have you made any changes in the use of protection from sexually-transmitted infections (STIs) or pregnancy? Item response categories included: I have never had sexual intercourse; I haven't had sexual intercourse in the past 12 months; no; yes. If response was yes, study participants were asked to identify their previous contraceptive method and their current contraceptive method. Contraceptive methods were coded as reliable or not reliable.

  6. Changes to contraceptive method in last year

    Time frame: 1 year

    Study participants were asked, "During the last year, have you made any changes in the use of protection from sexually-transmitted infections (STIs) or pregnancy? Item response categories included: I have never had sexual intercourse; I haven't had sexual intercourse in the past 12 months; no; yes. If response was yes, study participants were asked to identify their previous contraceptive method and their current contraceptive method. Contraceptive methods were coded as reliable or not reliable.

  7. Ever visited doctor/clinic for birth control, exam, or STI

    Time frame: Prior to program participation (baseline)

    Study participants were asked, "j. Have you ever been to a doctor or to a clinic to get birth control, to have a pelvic exam, a testicular exam or to get a check up for sexually transmitted infections?" Item responses were Yes/No.

  8. Ever visited doctor/clinic for birth control, exam, or STI

    Time frame: 1 year

    Study participants were asked, "j. Have you ever been to a doctor or to a clinic to get birth control, to have a pelvic exam, a testicular exam or to get a check up for sexually transmitted infections?" Item responses were Yes/No.

Secondary outcomes

  1. Comfort with own sexuality scale

    Time frame: Prior to program participation (baseline)

    Seven-items that measured such things as comfort talking with a date about sex or birth control and having a good understanding of one's own sexual feelings and reactions (alpha = 0.7545). Each item was rated on a scale of 1 to 4, with the most desirable response being 4.

  2. Comfort with own sexuality scale

    Time frame: 1 year

    Seven-items that measured such things as comfort talking with a date about sex or birth control and having a good understanding of one's own sexual feelings and reactions (alpha = 0.7545). Each item was rated on a scale of 1 to 4, with the most desirable response being 4.

  3. Confidence in peer education skills scale

    Time frame: Prior to program participation (baseline)

    Eight-items, on a scale of 1 to 4, that measured confidence in accessing current information about sexually transmitted diseases and infections or explaining proper condom usage to peers (alpha = 0.7525).

  4. Confidence in peer education skills scale

    Time frame: 1 year

    Eight-items, on a scale of 1 to 4, that measured confidence in accessing current information about sexually transmitted diseases and infections or explaining proper condom usage to peers (alpha = 0.7525).

  5. Civic action scale

    Time frame: Prior to program participation (baseline)

    Six-item scale adapted from Flanagan et al. to measure ability to be actively engaged citizens (alpha = 0.6789). The scale, rated on a scale of 1 to 4, measured such things as the strength of their belief that they can make a difference in their communities and confidence that they can express their views in front of a group.

  6. Civic action scale

    Time frame: 1 year

    Six-item scale adapted from Flanagan et al. to measure ability to be actively engaged citizens (alpha = 0.6789). The scale, rated on a scale of 1 to 4, measured such things as the strength of their belief that they can make a difference in their communities and confidence that they can express their views in front of a group.

  7. Perspective taking scale

    Time frame: Prior to program participation (baseline)

    Seven-item sub-scale from the Interpersonal Reactivity Index measuring the ability of youth to be empathetic and understand the perspective of others (alpha = 0.7158). This 5-point subscale included items to measure attempts to understand their friends by imagining how things look from their perspective and trying to look at both sides of every question. The scale language was adapted to be more gender neutral, with permission of the author.

  8. Perspective taking scale

    Time frame: 1 year

    Seven-item sub-scale from the Interpersonal Reactivity Index measuring the ability of youth to be empathetic and understand the perspective of others (alpha = 0.7158). This 5-point subscale included items to measure attempts to understand their friends by imagining how things look from their perspective and trying to look at both sides of every question. The scale language was adapted to be more gender neutral, with permission of the author.

  9. Communication with parents

    Time frame: Prior to program participation (baseline)

    Two items about teen comfort talking with parents about sex and birth control, rated 1 to 4, with 4 indicating the highest level of comfort. These two items were examined individually. A third item measured whether youth had conversations with parents about sexuality or birth control in the past year (yes/no). A final item had teens report the number of such conversations in five unequal categories (0,1-5, 6-10, 11-15, and more than 15), then dichotomized to 10 or fewer conversations (0) and more than ten conversations (1).

  10. Communication with parents

    Time frame: 1 year

    Two items about teen comfort talking with parents about sex and birth control, rated 1 to 4, with 4 indicating the highest level of comfort. These two items were examined individually. A third item measured whether youth had conversations with parents about sexuality or birth control in the past year (yes/no). A final item had teens report the number of such conversations in five unequal categories (0,1-5, 6-10, 11-15, and more than 15), then dichotomized to 10 or fewer conversations (0) and more than ten conversations (1).

Sponsors and collaborators

Lead sponsor

Philliber Research & Evaluation

Other

Registry information

Official study title

Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky Teen Council Program Study

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 21, 2021
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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