The P4 Intervention Study to Improve Adolescent Health

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adolescent Behavior

Intervention / Treatment
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* Behavioral: Sexual Health
* Behavioral: Alcohol Prevention
* Behavioral: Teen Driving


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sexual Health<br>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. | Behavioral: Sexual Health<br>* Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.<br>|
| Other: Alcohol Prevention<br>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. | Behavioral: Alcohol Prevention<br>* Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.<br>|
| No Intervention: Sexual Health & Alcohol Control Group<br>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. | |
| Other: Teen Driving<br>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. | Behavioral: Teen Driving<br>* 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.<br>|
| No Intervention: Teen Driving Control<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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)). | 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)). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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 | 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). | 6 months post-enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent Health, Sexual Health, Parent-Teen Communication, Teen Driving, Alcohol Prevention