A Pilot Efficacy and Implementation Study of the Patients, Parents and Professionals Partnering to Improve Adolescent Health (P4) Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Parent-teen Communication About Stopping a Friend From Driving Under the Influence of Drugs or Alcohol
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sexual Health (Behavioral)
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.
干预措施: Alcohol Prevention (Behavioral)
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.
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.
干预措施: Teen Driving (Behavioral)
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.
结局指标
主要结局
Parent-teen Communication About Stopping a Friend From Driving Under the Influence of Drugs or Alcohol
时间窗: 6 months post-enrollment
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
Parent-teen Communication About Pennsylvania's Graduated Driver Licensing Laws
时间窗: 6 months post-enrollment
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).
Quality of Parent-teen Communication (General- All Groups)
时间窗: 4-6 months post-enrollment
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.
Frequency of Communication About Alcohol
时间窗: 4-6 months post-enrollment
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)).
Frequency of Communication About Sex
时间窗: 4-6 months post-enrollment
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)).
Parent-teen Communication About Being a Safe Passenger
时间窗: 6 months post-enrollment
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).
Parent-teen Communication About What to do in a Crash
时间窗: 6 months post-enrollment
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).
Parent-teen Communication About Driving Under the Influence of Drugs or Alcohol
时间窗: 6 months post-enrollment
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).
Parent-teen Communication About What to do if the Teen Needs a Safe Ride Home
时间窗: 6 months post-enrollment
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).
Parent-teen Communication About Reasons the Teen Wants to Drive
时间窗: 6 months post-enrollment
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).
Parent-teen Communication About the Kinds of Risky Driving Situations That Might Come up in His or Her Friend Group
时间窗: 6 months post-enrollment
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).
Parent-teen Communication About Wearing a Seatbelt
时间窗: 6 months post-enrollment
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).
Parent-teen Communication About Dangers of Distracted Driving
时间窗: 6 months post-enrollment
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).
Parent-teen Communication About What to do if Stopped by a Police Officer
时间窗: 6 months post-enrollment
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).
Parent-teen Communication About Stopping a Friend From Riding With a Driver Who is Under the Influence of Drugs or Alcohol
时间窗: 6 months post-enrollment
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).
次要结局
未报告次要终点