Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
348 participants
INTERVENTIONAL
2016-01-31
2017-04-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Talking Matters Teen Pregnancy Prevention Program
NCT04970485
Parents Matter!: Interventions to Promote Effective Parent-Child Communication
NCT00137943
Sexual Health Texting Intervention to Support Adolescent Females
NCT02419690
Effect of HIV/STD Risk Reduction Program on South African Adolescents
NCT00559403
Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents
NCT00640653
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sexual Health
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.
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
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.
Alcohol Prevention
Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
Sexual Health & Alcohol Control Group
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.
No interventions assigned to this group
Teen Driving
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.
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.
Teen Driving Control
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
14 Years
17 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Children's Hospital of Philadelphia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carol A Ford, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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. doi: 10.1177/1090198106293524. Epub 2006 Dec 15.
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.
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.
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. doi: 10.2105/AJPH.2003.018952.
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.
Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2009. Natl Vital Stat Rep. 2010 Dec;59(3):1-19.
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. doi: 10.1002/cd.48. No abstract available.
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.
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. doi: 10.1016/s0001-4575(02)00047-7.
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. doi: 10.1016/s0001-4575(02)00006-4.
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.
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.
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
Stattin H, Kerr M. Parental monitoring: a reinterpretation. Child Dev. 2000 Jul-Aug;71(4):1072-85. doi: 10.1111/1467-8624.00210.
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. doi: 10.1037//0893-164x.15.4.366.
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. doi: 10.1363/psrh.36.6.04.
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.
Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15-011732
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.