The P4 Intervention Study to Improve Adolescent Health

Adolescent Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554682
• Other study ID #: 15-011732
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: April 10, 2017

Study information

• Verified date: April 2019
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: April 10, 2017
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior

Intervention

Behavioral:
• Sexual Health
Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
• Alcohol Prevention
Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
• Teen Driving
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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2009. Natl Vital Stat Rep. 2010 Dec;59(3):1-19. — View Citation

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. Review. — View Citation

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. Erratum in: MMWR Morb Wkly Rep. 2014 Jul 4;63(26):576. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. Epub 2006 Dec 15. — View Citation

Stattin H, Kerr M. Parental monitoring: a reinterpretation. Child Dev. 2000 Jul-Aug;71(4):1072-85. — View Citation

Turrisi R, Jaccard J, Taki R, Dunnam H, Grimes J. Examination of the short-term efficacy of a parent intervention to reduce college student drinking tendencies. Psychol Addict Behav. 2001 Dec;15(4):366-72. — View Citation

Weinstock H, Berman S, Cates W Jr. Sexually transmitted diseases among American youth: incidence and prevalence estimates, 2000. Perspect Sex Reprod Health. 2004 Jan-Feb;36(1):6-10. — View Citation

Winston FK, Mirman JH, Curry AE, Pfeiffer MR, Elliott MR, Durbin DR. Engagement with the TeenDrivingPlan and diversity of teens' supervised practice driving: lessons for internet-based learner driver interventions. Inj Prev. 2015 Feb;21(1):4-9. doi: 10.1136/injuryprev-2014-041212. Epub 2014 Jun 10. — View Citation

Zimet G, Dahlem NV, Zimet SG, Farley GK. The multidimensional scale of perceived social support. Journal of Personality Assessment. 52;30-41. 1988.

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, a parent = 0.84, and 43-96, a teen = 0.87.	4-6 months post-enrollment
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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