Adolescent BehaviorNCT02554682

The P4 Intervention Study to Improve Adolescent Health

A study testing Sexual Health, Alcohol Prevention and Teen Driving in people with Adolescent Behavior, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 14 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Adolescent Behavior
What is being tested?: Sexual Health, Alcohol Prevention and Teen Driving
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 348 participants
Where: 1 siteUnited States
Study dates: Jan 2016to 10 Apr 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Conditions: Adolescent Behavior
Being tested: Sexual Health, Alcohol Prevention, Teen Driving
Keywords: Adolescent Health, Sexual Health, Parent-Teen Communication, Teen Driving, Alcohol Prevention
Medical subject headings: Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sexual HealthBehavioural
Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
Alcohol PreventionBehavioural
Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Teen DrivingBehavioural
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.

Study groups in NCT02554682
Study group	Role	What they receive
Sexual Health	Other	Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Receives: Behavioral: Sexual Health
Alcohol Prevention	Other	Parents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials. Receives: Behavioral: Alcohol Prevention
Sexual Health & Alcohol Control Group	No intervention	Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Teen Driving	Other	Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials. Receives: Behavioral: Teen Driving
Teen Driving Control	No intervention	Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.

What is being measured

The primary outcome is the main question the study is designed to answer.

Quality of Parent-teen Communication (General- All Groups)
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.
Measured: 4-6 months post-enrollment
Frequency of Communication About Alcohol
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)).
Measured: 4-6 months post-enrollment
Frequency of Communication About Sex
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)).
Measured: 4-6 months post-enrollment
Parent-teen Communication About Reasons the Teen Wants to Drive
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).
Measured: 6 months post-enrollment
Parent-teen Communication About the Kinds of Risky Driving Situations That Might Come up in His or Her Friend Group
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).
Measured: 6 months post-enrollment
Parent-teen Communication About Pennsylvania's Graduated Driver Licensing Laws
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).
Measured: 6 months post-enrollment
Parent-teen Communication About Wearing a Seatbelt
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).
Measured: 6 months post-enrollment
Parent-teen Communication About Dangers of Distracted Driving
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).
Measured: 6 months post-enrollment
Parent-teen Communication About Being a Safe Passenger
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).
Measured: 6 months post-enrollment
Parent-teen Communication About What to do in a Crash
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).
Measured: 6 months post-enrollment
Parent-teen Communication About What to do if Stopped by a Police Officer
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).
Measured: 6 months post-enrollment
Parent-teen Communication About Driving Under the Influence of Drugs or Alcohol
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).
Measured: 6 months post-enrollment
Parent-teen Communication About What to do if the Teen Needs a Safe Ride Home
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).
Measured: 6 months post-enrollment
Parent-teen Communication About Stopping a Friend From Driving Under the Influence of Drugs or Alcohol
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
Measured: 6 months post-enrollment
Parent-teen Communication About Stopping a Friend From Riding With a Driver Who is Under the Influence of Drugs or Alcohol
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).
Measured: 6 months post-enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201610 Apr 2017

First posted18 Sep 2015 (estimated)
Study startJan 2016
Primary completion10 Apr 2017
Study completion10 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 348 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02554682
Sponsor's protocol ID: 15-011732
Status last verified: Apr 2019
First submitted: 16 Sep 2015
Last updated: 10 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Kann L, Kinchen S, Shanklin SL, Flint KH, Kawkins J, Harris WA, Lowry R, Olsen EO, McManus T, Chyen D, Whittle L, Taylor E, Demissie Z, Brener N, Thornton J, Moore J, Zaza S; Centers for Disease Control and Prevention (CDC). Youth risk behavior surveillance--United States, 2013. MMWR Suppl. 2014 Jun 13;63(4):1-168.
PubMed 24918634
Sales JM, Milhausen RR, Wingood GM, Diclemente RJ, Salazar LF, Crosby RA. Validation of a Parent-Adolescent Communication Scale for use in STD/HIV prevention interventions. Health Educ Behav. 2008 Jun;35(3):332-45. doi: 10.1177/1090198106293524. Epub 2006 Dec 15.
PubMed 17200099
Ford CA, Cheek C, Culhane J, Fishman J, Mathew L, Salek EC, Webb D, Jaccard J. Parent and Adolescent Interest in Receiving Adolescent Health Communication Information From Primary Care Clinicians. J Adolesc Health. 2016 Aug;59(2):154-61. doi: 10.1016/j.jadohealth.2016.03.001. Epub 2016 Apr 14.
PubMed 27151760
Ford CA, Davenport AF, Meier A, McRee AL. Partnerships between parents and health care professionals to improve adolescent health. J Adolesc Health. 2011 Jul;49(1):53-7. doi: 10.1016/j.jadohealth.2010.10.004. Epub 2011 Mar 12.
PubMed 21700157
Guilamo-Ramos V, Jaccard J, Turrisi R, Johansson M. Parental and school correlates of binge drinking among middle school students. Am J Public Health. 2005 May;95(5):894-9. doi: 10.2105/AJPH.2003.018952.
PubMed 15855471
Guilamo-Ramos V, Bouris A, Jaccard J, Gonzalez B, McCoy W, Aranda D. A parent-based intervention to reduce sexual risk behavior in early adolescence: building alliances between physicians, social workers, and parents. J Adolesc Health. 2011 Feb;48(2):159-63. doi: 10.1016/j.jadohealth.2010.06.007.
PubMed 21257114
Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2009. Natl Vital Stat Rep. 2010 Dec;59(3):1-19.
PubMed 25073731
Jaccard J, Dodge T, Dittus P. Parent-adolescent communication about sex and birth control: a conceptual framework. New Dir Child Adolesc Dev. 2002 Fall;(97):9-41. doi: 10.1002/cd.48. No abstract available.
PubMed 14964942
Kerr M, Stattin H. What parents know, how they know it, and several forms of adolescent adjustment: further support for a reinterpretation of monitoring. Dev Psychol. 2000 May;36(3):366-80.
PubMed 10830980
Mayhew DR, Simpson HM, Pak A. Changes in collision rates among novice drivers during the first months of driving. Accid Anal Prev. 2003 Sep;35(5):683-91. doi: 10.1016/s0001-4575(02)00047-7.
PubMed 12850069
McCartt AT, Shabanova VI, Leaf WA. Driving experience, crashes and traffic citations of teenage beginning drivers. Accid Anal Prev. 2003 May;35(3):311-20. doi: 10.1016/s0001-4575(02)00006-4.
PubMed 12643948
Mirman JH, Curry AE, Winston FK, Wang W, Elliott MR, Schultheis MT, Fisher Thiel MC, Durbin DR. Effect of the teen driving plan on the driving performance of teenagers before licensure: a randomized clinical trial. JAMA Pediatr. 2014 Aug;168(8):764-71. doi: 10.1001/jamapediatrics.2014.252.
PubMed 24957844
Mirman JH, Albert WD, Curry AE, Winston FK, Fisher Thiel MC, Durbin DR. TeenDrivingPlan effectiveness: the effect of quantity and diversity of supervised practice on teens' driving performance. J Adolesc Health. 2014 Nov;55(5):620-6. doi: 10.1016/j.jadohealth.2014.04.010. Epub 2014 Jun 9.
PubMed 24925492
Olson, D. H.. Family inventories: Inventories used in a national survey of families across the life cycle. St Paul, MN: Family Social Science, University of Minnesota. 1985
Stattin H, Kerr M. Parental monitoring: a reinterpretation. Child Dev. 2000 Jul-Aug;71(4):1072-85. doi: 10.1111/1467-8624.00210.
PubMed 11016567

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Efficacy and Implementation Study of the Patients, Parents and Professionals Partnering to Improve Adolescent Health (P4) Intervention
ClinicalTrials.gov ID: NCT02554682
Acronym / sponsor ID: 15-011732
Conditions: Adolescent Behavior
Keywords: Adolescent Health, Sexual Health, Parent-Teen Communication, Teen Driving, Alcohol Prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 348 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Study start: Jan 2016
Primary completion: 10 Apr 2017 (actual)
Study completion: 10 Apr 2017 (actual)
First posted: 18 Sep 2015 (estimated)
Results: Posted 25 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Sexual Health	Other	Behavioral: Sexual HealthParents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to sexual health at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.
Alcohol Prevention	Other	Behavioral: Alcohol PreventionParents of teens between the ages of 14 and 15 will review psychoeducational workbooks related to alcohol prevention at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 4 to 5 months post baseline we will collect data to assess the efficacy of the study materials.
Sexual Health & Alcohol Control Group	No intervention	–Parents of teens between the ages of 14 and 15 will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 4 to 5 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from both the sexual health and alcohol prevention groups.
Teen Driving	Other	Behavioral: Teen DrivingParents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will review psychoeducational workbooks related to teen driving at a well-child visit appointment with the primary care giver (baseline); 2 weeks after baseline they will received a follow-up phone call and health coaching session to review the materials and ask questions; and then at 6 months post baseline we will collect data to assess the effectiveness of the study materials.
Teen Driving Control	No intervention	–Parents of teens between the ages of 16 and 17 who are planning on having the medical certification for the permit application completed and plan on taking their driving permit test in the next 8 weeks will receive their usual care at their well-child visit appointment with their primary care giver (baseline) and then at 6 months post baseline we will collect data. At the end of the post data collection, the control group will get all of the study materials from the teen driving group.

Who may qualify

Ages: 14 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sexual HealthPsychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.	Behavioural	Sexual Health
Alcohol PreventionPsychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.	Behavioural	Alcohol Prevention
Teen DrivingPsychoeducational 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.	Behavioural	Teen Driving

Primary outcome

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.
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)).
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)).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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
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).

Results and safety

Results posted to the registry on 25 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sexual Health (Teen)	40	25
Sexual Health (Parent)	40	28
Alcohol Prevention (Teen)	40	36
Alcohol Prevention (Parent)	40	37
Sexual Health & Alcohol Control Group (Teen)	40	38
Sexual Health & Alcohol Group (Parent)	40	39
Teen Driving (Teen)	28	22
Teen Driving (Parent)	28	22
Teen Driving Control (Teen)	26	24
Teen Driving Control (Parent)	26	24

Primary outcome: Quality of Parent-teen Communication (General- All Groups)

Time frame: 4-6 months post-enrollment. Mean (Standard Deviation). Unit: units on a scale

Measure	Sexual Health (Parent) n = 28	Sexual Health (Teen) n = 25	Alcohol Prevention (Parent) n = 37	Alcohol (Teen) n = 36	Sexual Health & Alcohol Control Group (Parent) n = 39	Sexual Health and Alcohol Control Group (Teen) n = 38
Value	77.8 (10.5)	73.0 (9.4)	77.2 (8.6)	69.1 (8.4)	77.4 (10.3)	68.6 (11.1)

Alcohol Prevention (Parent) vs Sexual Health & Alcohol Control Group (Parent): p = .906, Generalized Linear Model
Alcohol (Teen) vs Sexual Health and Alcohol Control Group (Teen): p = .796, Generalized Linear Model
Sexual Health (Parent) vs Sexual Health & Alcohol Control Group (Parent): p = .886, Generalized Linear Model

Population analysed: Arm 1 only. Parents and teens analyzed separately. Arm 2 (teen driving) had different primary outcomes (see outcomes 4-15) and therefore was not included here.

Primary outcome: Frequency of Communication About Alcohol

Time frame: 4-6 months post-enrollment. Mean (Standard Deviation). Unit: units on a scale

Measure	Sexual Health (Teen) n = 25	Sexual Health (Parent) n = 28	Alcohol Prevention (Teen) n = 36	Alcohol Prevention (Parent) n = 37	Sexual Health & Alcohol Control Group (Teen) n = 38	Sexual Health & Alcohol Group (Parent) n = 39
Value	2.7 (1.0)	2.5 (0.8)	2.9 (0.8)	2.6 (0.8)	2.4 (1.2)	2.5 (0.9)

Alcohol Prevention (Parent) vs Sexual Health & Alcohol Group (Parent): p = 0.677, Generalized Linear Model
Alcohol Prevention (Teen) vs Sexual Health & Alcohol Control Group (Teen): p = 0.020, Generalized Linear Model
Sexual Health (Parent) vs Sexual Health & Alcohol Group (Parent): p = .952, Generalized Linear Model

Population analysed: Arm 1 only. Parents and teens analyzed separately. Arm 2 (teen driving) had different primary outcomes (see outcomes 4-15) and therefore was not included here.

Primary outcome: Frequency of Communication About Sex

Time frame: 4-6 months post-enrollment. Mean (Standard Deviation). Unit: units on a scale

Measure	Sexual Health (Teen) n = 25	Sexual Health (Parent) n = 28	Alcohol Prevention (Teen) n = 36	Alcohol Prevention (Parent) n = 37	Sexual Health & Alcohol Control Group (Teen) n = 38	Sexual Health & Alcohol Group (Parent) n = 39
Value	2.3 (0.8)	2.8 (0.8)	2.1 (1.1)	2.3 (0.9)	1.8 (0.8)	2.4 (1.0)

Alcohol Prevention (Parent) vs Sexual Health & Alcohol Group (Parent): p = 0.505, Generalized Linear Model
Alcohol Prevention (Teen) vs Sexual Health & Alcohol Control Group (Teen): p = .176, Generalized Linear Model
Sexual Health (Parent) vs Sexual Health & Alcohol Group (Parent): p = 0.134, Generalized Linear Model

Population analysed: Arm 1 only. Parents and teens analyzed separately. Arm 2 (teen driving) had different primary outcomes (see outcomes 4-15) and therefore was not included here.

Primary outcome: Parent-teen Communication About Reasons the Teen Wants to Drive

Time frame: 6 months post-enrollment. Mean (Standard Deviation). Unit: units on a scale

Measure	Teen Driving (Parents) n = 22	Teen Driving Control (Parents) n = 24
Value	2.32 (.89)	1.75 (.90)

Teen Driving (Parents) vs Teen Driving Control (Parents): p = .037, t-test, 2 sided

Population analysed: Parent Population

Adverse events

Time frame: Adverse event data was collected at each time point (e.g. Baseline, 2wk follow up, final follow up).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sexual Health	0 of 80 (0%)	0 of 80 (0%)	0 of 80
Alcohol Prevention	0 of 80 (0%)	0 of 80 (0%)	0 of 80
Sexual Health & Alcohol Control Group	0 of 80 (0%)	0 of 80 (0%)	0 of 80
Teen Driving	0 of 56 (0%)	0 of 56 (0%)	0 of 56
Teen Driving Control	0 of 52 (0%)	0 of 52 (0%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24918634Kann L, Kinchen S, Shanklin SL, Flint KH, Kawkins J, Harris WA, Lowry R, Olsen EO, McManus T, Chyen D, Whittle L, Taylor E, Demissie Z, Brener N, Thornton J, Moore J, Zaza S; Centers for Disease Control and Prevention (CDC). Youth risk behavior surveillance--United States, 2013. MMWR Suppl. 2014 Jun 13;63(4):1-168.
Background: PubMed 17200099Sales JM, Milhausen RR, Wingood GM, Diclemente RJ, Salazar LF, Crosby RA. Validation of a Parent-Adolescent Communication Scale for use in STD/HIV prevention interventions. Health Educ Behav. 2008 Jun;35(3):332-45. doi: 10.1177/1090198106293524. Epub 2006 Dec 15.
Background: PubMed 27151760Ford CA, Cheek C, Culhane J, Fishman J, Mathew L, Salek EC, Webb D, Jaccard J. Parent and Adolescent Interest in Receiving Adolescent Health Communication Information From Primary Care Clinicians. J Adolesc Health. 2016 Aug;59(2):154-61. doi: 10.1016/j.jadohealth.2016.03.001. Epub 2016 Apr 14.
Background: PubMed 21700157Ford CA, Davenport AF, Meier A, McRee AL. Partnerships between parents and health care professionals to improve adolescent health. J Adolesc Health. 2011 Jul;49(1):53-7. doi: 10.1016/j.jadohealth.2010.10.004. Epub 2011 Mar 12.
Background: PubMed 15855471Guilamo-Ramos V, Jaccard J, Turrisi R, Johansson M. Parental and school correlates of binge drinking among middle school students. Am J Public Health. 2005 May;95(5):894-9. doi: 10.2105/AJPH.2003.018952.
Background: PubMed 21257114Guilamo-Ramos V, Bouris A, Jaccard J, Gonzalez B, McCoy W, Aranda D. A parent-based intervention to reduce sexual risk behavior in early adolescence: building alliances between physicians, social workers, and parents. J Adolesc Health. 2011 Feb;48(2):159-63. doi: 10.1016/j.jadohealth.2010.06.007.
Background: PubMed 25073731Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2009. Natl Vital Stat Rep. 2010 Dec;59(3):1-19.
Background: PubMed 14964942Jaccard J, Dodge T, Dittus P. Parent-adolescent communication about sex and birth control: a conceptual framework. New Dir Child Adolesc Dev. 2002 Fall;(97):9-41. doi: 10.1002/cd.48. No abstract available.
Background: PubMed 10830980Kerr M, Stattin H. What parents know, how they know it, and several forms of adolescent adjustment: further support for a reinterpretation of monitoring. Dev Psychol. 2000 May;36(3):366-80.
Background: PubMed 12850069Mayhew DR, Simpson HM, Pak A. Changes in collision rates among novice drivers during the first months of driving. Accid Anal Prev. 2003 Sep;35(5):683-91. doi: 10.1016/s0001-4575(02)00047-7.
Background: PubMed 12643948McCartt AT, Shabanova VI, Leaf WA. Driving experience, crashes and traffic citations of teenage beginning drivers. Accid Anal Prev. 2003 May;35(3):311-20. doi: 10.1016/s0001-4575(02)00006-4.
Background: PubMed 24957844Mirman JH, Curry AE, Winston FK, Wang W, Elliott MR, Schultheis MT, Fisher Thiel MC, Durbin DR. Effect of the teen driving plan on the driving performance of teenagers before licensure: a randomized clinical trial. JAMA Pediatr. 2014 Aug;168(8):764-71. doi: 10.1001/jamapediatrics.2014.252.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carol A Ford, MD principal investigator

Children's Hospital of Philadelphia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sexual Health, Alcohol Prevention and Teen Driving in people with Adolescent Behavior, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Parent-teen Communication (General- All Groups) (time frame: 4-6 months post-enrollment). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02554682, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.