The P4 Intervention Study to Improve Adolescent Health

NCT02554682 | Completed Results

• 1 other identifier: 15-011732
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adolescent Behavior

Keywords

Adolescent Health; Sexual Health; Parent-Teen Communication; Teen Driving; Alcohol Prevention

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (5)

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.

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.

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.

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.

Interventions

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.

Sexual Health

Alcohol Prevention BEHAVIORAL

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

Alcohol Prevention

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.

Teen Driving

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (20)

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• Ford CA, Mirman JH, Garcia-Espana JF, Fisher Thiel MC, Friedrich E, Salek EC, Jaccard J. Effect of Primary Care Parent-Targeted Interventions on Parent-Adolescent Communication About Sexual Behavior and Alcohol Use: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199535. doi: 10.1001/jamanetworkopen.2019.9535.

  PMID: 31418808 DERIVED

MeSH Terms

Conditions

Adolescent Behavior

Interventions

Sexual Health; Ethanol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health; Population Characteristics; Alcohols; Organic Chemicals

Results Point of Contact

• Title: Dr. Carol Ford
• Organization: Children's Hospital of Philadelphia

fordc@email.chop.edu

267-426-3938

Study Officials

• Carol A Ford, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 18, 2015
• Study Start: January 1, 2016
• Primary Completion: April 10, 2017
• Study Completion: April 10, 2017
• Last Updated: April 10, 2019
• Results First Posted: March 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)