The P4 Intervention Study to Improve Adolescent Health

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Adolescent Behavior

Treatments: Behavioral: Sexual Health; Behavioral: Alcohol Prevention; Behavioral: Teen Driving

Study type: Interventional

Funder types: Other

Identifiers

NCT02554682

15-011732

Details and patient eligibility

About

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.

Full 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.

Enrollment: 348 patients

Sex: All

Ages: 14 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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348 participants in 5 patient groups

Sexual Health

Other group

Description:

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.

Treatment:

Behavioral: Sexual Health

Alcohol Prevention

Other group

Description:

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.

Treatment:

Behavioral: Alcohol Prevention

Sexual Health & Alcohol Control Group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Teen Driving

Teen Driving Control

No Intervention group

Description:

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.