Clinical trial NCT02554682: The P4 Intervention Study to Improve Adolescent Health
Official title: A Pilot Efficacy and Implementation Study of the Patients, Parents and Professionals Partnering to Improve Adolescent Health (P4) Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Keywords: Adolescent Health
Sexual Health
Parent-Teen Communication
Teen Driving
Alcohol Prevention
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 348
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

1. CHOP Primary Care patient
2. Scheduled for a well-child visit that parent and teen both plan to attend within 3 weeks of enrollment
3. \[Teen Driving Arm Only\] 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:

1. Not fluent in written or spoken English
2. Developmental Delay or Pervasive Developmental Disorder
3. Pregnant female
4. \[Teen Driving Arm Only\] 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

Primary outcomes:
measure: Quality of Parent-teen Communication (General- All Groups)
timeFrame: 4-6 months post-enrollment
measure: Frequency of Communication About Alcohol
timeFrame: 4-6 months post-enrollment
measure: Frequency of Communication About Sex
timeFrame: 4-6 months post-enrollment
measure: Parent-teen Communication About Reasons the Teen Wants to Drive
timeFrame: 6 months post-enrollment
measure: Parent-teen Communication About the Kinds of Risky Driving Situations That Might Come up in His or Her Friend Group
timeFrame: 6 months post-enrollment
measure: Parent-teen Communication About Pennsylvania's Graduated Driver Licensing Laws
timeFrame: 6 months post-enrollment
measure: Parent-teen Communication About Wearing a Seatbelt
timeFrame: 6 months post-enrollment
measure: Parent-teen Communication About Dangers of Distracted Driving
timeFrame: 6 months post-enrollment
measure: Parent-teen Communication About Being a Safe Passenger
timeFrame: 6 months post-enrollment
measure: Parent-teen Communication About What to do in a Crash
timeFrame: 6 months post-enrollment
measure: Parent-teen Communication About What to do if Stopped by a Police Officer
timeFrame: 6 months post-enrollment
measure: Parent-teen Communication About Driving Under the Influence of Drugs or Alcohol
timeFrame: 6 months post-enrollment
measure: Parent-teen Communication About What to do if the Teen Needs a Safe Ride Home
timeFrame: 6 months post-enrollment
measure: Parent-teen Communication About Stopping a Friend From Driving Under the Influence of Drugs or Alcohol
timeFrame: 6 months post-enrollment
measure: Parent-teen Communication About Stopping a Friend From Riding With a Driver Who is Under the Influence of Drugs or Alcohol
timeFrame: 6 months post-enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Carol A Ford, MD
role: PRINCIPAL_INVESTIGATOR
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