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Planned Parenthood Teen Council Program Study

Primary Purpose

Adolescent Problem Behavior

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Teen Council
Sponsored by
Philliber Research & Evaluation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adolescent Problem Behavior focused on measuring Adolescent pregnancy prevention, Youth development

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Teen Council Pogram

    Control Group

    Arm Description

    Teens assigned to the intervention group received a 1-year long Teen Council Program.

    Teens assigned to the control group did not receive any intervention.

    Outcomes

    Primary Outcome Measures

    Ever had sex
    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.
    Ever had sex
    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.
    Contraceptive use at last intercourse
    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.
    Contraceptive use at last intercourse
    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.
    Changes to contraceptive method in last 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.
    Changes to contraceptive method in last 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.
    Ever visited doctor/clinic for birth control, exam, or STI
    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.
    Ever visited doctor/clinic for birth control, exam, or STI
    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 Outcome Measures

    Comfort with own sexuality scale
    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.
    Comfort with own sexuality scale
    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.
    Confidence in peer education skills scale
    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).
    Confidence in peer education skills scale
    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).
    Civic action scale
    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.
    Civic action scale
    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.
    Perspective taking scale
    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.
    Perspective taking scale
    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.
    Communication with parents
    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).
    Communication with parents
    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).

    Full Information

    First Posted
    September 30, 2021
    Last Updated
    October 18, 2021
    Sponsor
    Philliber Research & Evaluation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05087004
    Brief Title
    Planned Parenthood Teen Council Program Study
    Official Title
    Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky Teen Council Program Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2014 (Actual)
    Primary Completion Date
    August 6, 2019 (Actual)
    Study Completion Date
    August 6, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Philliber Research & Evaluation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adolescent Problem Behavior
    Keywords
    Adolescent pregnancy prevention, Youth development

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    810 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Teen Council Pogram
    Arm Type
    Experimental
    Arm Description
    Teens assigned to the intervention group received a 1-year long Teen Council Program.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Teens assigned to the control group did not receive any intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Teen Council
    Intervention Description
    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 Outcome Measure Information:
    Title
    Ever had sex
    Description
    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.
    Time Frame
    Prior to program participation (baseline)
    Title
    Ever had sex
    Description
    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.
    Time Frame
    1 year
    Title
    Contraceptive use at last intercourse
    Description
    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.
    Time Frame
    Prior to program participation (baseline)
    Title
    Contraceptive use at last intercourse
    Description
    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.
    Time Frame
    1 year
    Title
    Changes to contraceptive method in last year
    Description
    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.
    Time Frame
    Prior to program participation (baseline)
    Title
    Changes to contraceptive method in last year
    Description
    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.
    Time Frame
    1 year
    Title
    Ever visited doctor/clinic for birth control, exam, or STI
    Description
    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.
    Time Frame
    Prior to program participation (baseline)
    Title
    Ever visited doctor/clinic for birth control, exam, or STI
    Description
    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.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Comfort with own sexuality scale
    Description
    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.
    Time Frame
    Prior to program participation (baseline)
    Title
    Comfort with own sexuality scale
    Description
    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.
    Time Frame
    1 year
    Title
    Confidence in peer education skills scale
    Description
    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).
    Time Frame
    Prior to program participation (baseline)
    Title
    Confidence in peer education skills scale
    Description
    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).
    Time Frame
    1 year
    Title
    Civic action scale
    Description
    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.
    Time Frame
    Prior to program participation (baseline)
    Title
    Civic action scale
    Description
    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.
    Time Frame
    1 year
    Title
    Perspective taking scale
    Description
    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.
    Time Frame
    Prior to program participation (baseline)
    Title
    Perspective taking scale
    Description
    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.
    Time Frame
    1 year
    Title
    Communication with parents
    Description
    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).
    Time Frame
    Prior to program participation (baseline)
    Title
    Communication with parents
    Description
    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).
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Full study report is available upon request.

    Learn more about this trial

    Planned Parenthood Teen Council Program Study

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