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Completed

NCT Number: NCT02554682

The P4 Intervention Study to Improve Adolescent Health

The primary objective is to conduct a pilot study to determine the efficacy of evidence-based interventions delivered in primary care clinic settings on parent-teen health communication.

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Key information

Conditions

Adolescent Behavior Behavior

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

Primary care provides a means by which to connect evidence-based interventions with patients; however, many interventions have been evaluated using randomized controlled trials (RCTs) in non-healthcare settings.

The primary objective is to conduct a pilot study to determine the effect of evidence-based interventions delivered in primary care clinic settings on parent-teen communication about alcohol use, sexual health, and safe driving.

Eligible participants are healthy adolescent patients from the Children's Hospital of Philadelphia (CHOP) primary care network with a well-child visit scheduled between the ages of 14 to 17 years with one parent willing to participate. Adolescents that hold an intermediate driver's license, that are pregnant, or that have pervasive development disorder or a developmental delay are excluded from this study.

Parents will be given written psychoeducational intervention materials on communicating with their adolescents about alcohol use, sexual health, or safe driving (e.g.,booklets, tip sheet brochures, activity workbooks, web links), receive coaching about using the intervention materials, and provider endorsement of the materials during the well-child visit, as well as follow-up phone health coaching 2 weeks after the appointment.

The primary endpoints are evaluating the difference between the intervention and control groups on parent-teen communication on the targeted health topics.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • CHOP Primary Care patient
  • Scheduled for a well-child visit that parent and teen both plan to attend within 3 weeks of enrollment
  • [Teen Driving Arm Only] Planning on having the medical certification for the permit application completed at their next well child visit and planning on taking their driving permit test in the next 8 weeks

Exclusion criteria

  • Not fluent in written or spoken English
  • Developmental Delay or Pervasive Developmental Disorder
  • Pregnant female
  • [Teen Driving Arm Only] Already has driving permit (has taken and passed the knowledge test) and/or the medical certification for the permit application was not completed at the well child visit

Treatment and study plan

Sexual Health

Behavioral

Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.

Alcohol Prevention

Behavioral

Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.

Teen Driving

Behavioral

Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers.

Primary outcomes

  1. Quality of Parent-teen Communication (General- All Groups)

    Time frame: 4-6 months post-enrollment

    Parents completed the 20-item Parent-Adolescent Communication Scale (PACS) (Barnes & Olson, 1985) which is scored such that a higher total score (sum of all items across scales) indicated better parent-adolescent communication. Teens answered the same questions, with only minor changes in wording when necessary. Scores were summed into an index that ranged from 41-96, α parent = 0.84, and 43-96, α teen = 0.87.

  2. Frequency of Communication About Alcohol

    Time frame: 4-6 months post-enrollment

    Frequency of communication about alcohol was measured with a single item followed by 4-point Likert-type response categories. Parents were asked: Since your teen's last well-child visit how much have you talked with your teen about alcohol? (Not at all (1), A little bit (2), Quite a bit (3), or A lot (4)). Teens were asked: Since your last well-child visit, how often have you and your (mother/father) talked about alcohol? (Never (1), Rarely (2), Sometimes (3), or Often (4)).

  3. Frequency of Communication About Sex

    Time frame: 4-6 months post-enrollment

    Frequency of communication about sex was measured with a single item followed by 4-point Likert-type response categories. Parents were asked: Since your teen's last well-child visit how much have you talked with your teen about sex? (Not at all (1), A little bit (2), Quite a bit (3), or A lot (4)). Teens were asked: Since your last well-child visit, how often have you and your (mother/father) talked about sex? (Never (1), Rarely (2), Sometimes (3), or Often (4)).

  4. Parent-teen Communication About Reasons the Teen Wants to Drive

    Time frame: 6 months post-enrollment

    Six months after baseline, parents reported on the frequency that they talked about reasons the teen wants to drive. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

  5. Parent-teen Communication About the Kinds of Risky Driving Situations That Might Come up in His or Her Friend Group

    Time frame: 6 months post-enrollment

    Six months after baseline, parents reported on the frequency that they talked about the kinds of risky driving situations that might come up in his or her friend group. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

  6. Parent-teen Communication About Pennsylvania's Graduated Driver Licensing Laws

    Time frame: 6 months post-enrollment

    Six months after baseline, parents reported on the frequency that they talked about about Pennsylvania's GDL laws. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

  7. Parent-teen Communication About Wearing a Seatbelt

    Time frame: 6 months post-enrollment

    Six months after baseline, parents reported on the frequency that they talked about wearing a seatbelt. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

  8. Parent-teen Communication About Dangers of Distracted Driving

    Time frame: 6 months post-enrollment

    Six months after baseline, parents reported on the frequency that they talked about dangers of distracted driving. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

  9. Parent-teen Communication About Being a Safe Passenger

    Time frame: 6 months post-enrollment

    Six months after baseline, parents reported on the frequency that they talked about being a safe passenger. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

  10. Parent-teen Communication About What to do in a Crash

    Time frame: 6 months post-enrollment

    Six months after baseline, parents reported on the frequency that they talked about what to do in a crash. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

  11. Parent-teen Communication About What to do if Stopped by a Police Officer

    Time frame: 6 months post-enrollment

    Six months after baseline, parents reported on the frequency that they talked about what to do if stopped by a police officer. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

  12. Parent-teen Communication About Driving Under the Influence of Drugs or Alcohol

    Time frame: 6 months post-enrollment

    Six months after baseline, parents reported on the frequency that they talked about driving under the influence of drugs or alcohol. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

  13. Parent-teen Communication About What to do if the Teen Needs a Safe Ride Home

    Time frame: 6 months post-enrollment

    Six months after baseline, parents reported on the frequency that they talked about what to do if the teen needs a safe ride home. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

  14. Parent-teen Communication About Stopping a Friend From Driving Under the Influence of Drugs or Alcohol

    Time frame: 6 months post-enrollment

    Six months after baseline, parents reported on the frequency that they talked about stopping a friend from driving under the influence of drugs or alcohol. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).stopping a friend from riding with a driver who is under the influence of drugs or alcohol

  15. Parent-teen Communication About Stopping a Friend From Riding With a Driver Who is Under the Influence of Drugs or Alcohol

    Time frame: 6 months post-enrollment

    Six months after baseline, parents reported on the frequency that they talked about stopping a friend from riding with a driver who is under the influence of drugs or alcohol. Parents selected from one of the following response choices: "never talked about" (0); "talked about once or twice" (1); "talked about three or four times" (2); "talked about a lot, about 5 times or more" (3).

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

A Pilot Efficacy and Implementation Study of the Patients, Parents and Professionals Partnering to Improve Adolescent Health (P4) Intervention

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 18, 2015
Registry last updated
Apr 10, 2019

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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