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The P4 Intervention Study to Improve Adolescent Health

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02554682
Enrollment
348
Registered
2015-09-18
Start date
2016-01-31
Completion date
2017-04-10
Last updated
2019-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior

Keywords

Adolescent Health, Sexual Health, Parent-Teen Communication, Teen Driving, Alcohol 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.

Interventions

BEHAVIORALSexual Health

Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.

Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.

BEHAVIORALTeen 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.

Sponsors

Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Parent-teen Communication (General- All Groups)4-6 months post-enrollmentParents 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 Alcohol4-6 months post-enrollmentFrequency 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 Sex4-6 months post-enrollmentFrequency 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 Reasons the Teen Wants to Drive6 months post-enrollmentSix 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 Group6 months post-enrollmentSix 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 Pennsylvania's Graduated Driver Licensing Laws6 months post-enrollmentSix 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).
Parent-teen Communication About Wearing a Seatbelt6 months post-enrollmentSix 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 Driving6 months post-enrollmentSix 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 Being a Safe Passenger6 months post-enrollmentSix 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 Crash6 months post-enrollmentSix 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 What to do if Stopped by a Police Officer6 months post-enrollmentSix 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 Driving Under the Influence of Drugs or Alcohol6 months post-enrollmentSix 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 Home6 months post-enrollmentSix 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 Stopping a Friend From Driving Under the Influence of Drugs or Alcohol6 months post-enrollmentSix 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 Stopping a Friend From Riding With a Driver Who is Under the Influence of Drugs or Alcohol6 months post-enrollmentSix 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).

Countries

United States

Participant flow

Recruitment details

Adolescents between 14 and 17 years of age with an upcoming well-child visit and a parent were recruited from January 2016 through September 2016 from one urban primary care practice in the Pediatrics Research Consortium (PeRC) at Children's Hospital of Philadelphia (CHOP).

Pre-assignment details

A total of 425 parent-adolescent dyads were contacted and screened. Of these, 188 (44%) did not meet eligibility criteria, 26 (6%) declined, and 37 (9%) could not be scheduled or reached again. 174 participant dyads we randomized into one of the five assignment groups.

Participants by arm

ArmCount
Sexual Health (Teen)
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.
38
Sexual Health (Parent)
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.
38
Alcohol Prevention (Teen)
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.
40
Alcohol Prevention (Parent)
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.
40
Sexual Health & Alcohol Control Group (Teen)
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.
40
Sexual Health & Alcohol Control Group (Parent)
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.
40
Teen Driving (Teen)
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.
28
Teen Driving (Parent)
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.
28
Teen Driving Control (Teens)
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.
26
Teen Driving Control (Parent)
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.
26
Total344

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009
Overall StudyLost to Follow-up11943216622
Overall StudyPhysician Decision2200000000
Overall StudyWithdrawal by Subject2100000000

Baseline characteristics

CharacteristicTotalAlcohol Prevention (Teen)Sexual Health (Parent)Alcohol Prevention (Parent)Sexual Health & Alcohol Control Group (Teen)Sexual Health & Alcohol Control Group (Parent)Teen Driving (Teen)Teen Driving (Parent)Teen Driving Control (Teens)Sexual Health (Teen)Teen Driving Control (Parent)
Age, Categorical
<=18 years
172 Participants40 Participants0 Participants0 Participants40 Participants0 Participants28 Participants0 Participants26 Participants38 Participants0 Participants
Age, Categorical
>=65 years
2 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Age, Categorical
Between 18 and 65 years
170 Participants0 Participants37 Participants40 Participants0 Participants40 Participants0 Participants28 Participants0 Participants0 Participants25 Participants
Age, Continuous31.13 years
STANDARD_DEVIATION 16.47
14.83 years
STANDARD_DEVIATION 0.53
45.13 years
STANDARD_DEVIATION 8.6
45.20 years
STANDARD_DEVIATION 5.8
15.05 years
STANDARD_DEVIATION 0.58
47.05 years
STANDARD_DEVIATION 5.9
16.81 years
STANDARD_DEVIATION 0.56
46.57 years
STANDARD_DEVIATION 7.88
16.40 years
STANDARD_DEVIATION 0.4
14.71 years
STANDARD_DEVIATION 0.53
49.58 years
STANDARD_DEVIATION 8.5
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants2 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
5 Participants1 Participants0 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
200 Participants22 Participants20 Participants22 Participants19 Participants20 Participants24 Participants19 Participants18 Participants19 Participants17 Participants
Race (NIH/OMB)
More than one race
17 Participants2 Participants1 Participants3 Participants1 Participants1 Participants0 Participants4 Participants1 Participants2 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
118 Participants13 Participants17 Participants15 Participants18 Participants18 Participants4 Participants4 Participants7 Participants16 Participants6 Participants
Region of Enrollment
United States
344 Participants40 Participants38 Participants40 Participants40 Participants40 Participants28 Participants28 Participants26 Participants38 Participants26 Participants
Sex: Female, Male
Female
250 Participants21 Participants35 Participants39 Participants21 Participants38 Participants14 Participants28 Participants13 Participants18 Participants23 Participants
Sex: Female, Male
Male
94 Participants19 Participants3 Participants1 Participants19 Participants2 Participants14 Participants0 Participants13 Participants20 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 800 / 800 / 800 / 560 / 52
other
Total, other adverse events
0 / 800 / 800 / 800 / 560 / 52
serious
Total, serious adverse events
0 / 800 / 800 / 800 / 560 / 52

Outcome results

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)).

Time frame: 4-6 months post-enrollment

Population: Arm 1 only. Parents and teens analyzed separately. Arm 2 (teen driving) had different primary outcomes (see outcomes 4-15) and therefore was not included here.

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Frequency of Communication About Alcohol2.7 units on a scaleStandard Deviation 1
Sexual Health (Teen)Frequency of Communication About Alcohol2.5 units on a scaleStandard Deviation 0.8
Alcohol Prevention (Parent)Frequency of Communication About Alcohol2.9 units on a scaleStandard Deviation 0.8
Alcohol (Teen)Frequency of Communication About Alcohol2.6 units on a scaleStandard Deviation 0.8
Sexual Health & Alcohol Control Group (Parent)Frequency of Communication About Alcohol2.4 units on a scaleStandard Deviation 1.2
Sexual Health and Alcohol Control Group (Teen)Frequency of Communication About Alcohol2.5 units on a scaleStandard Deviation 0.9
p-value: 0.677Generalized Linear Model
p-value: 0.02Generalized Linear Model
p-value: 0.952Generalized Linear Model
p-value: 0.21Generalized Linear Model
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)).

Time frame: 4-6 months post-enrollment

Population: Arm 1 only. Parents and teens analyzed separately. Arm 2 (teen driving) had different primary outcomes (see outcomes 4-15) and therefore was not included here.

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Frequency of Communication About Sex2.3 units on a scaleStandard Deviation 0.8
Sexual Health (Teen)Frequency of Communication About Sex2.8 units on a scaleStandard Deviation 0.8
Alcohol Prevention (Parent)Frequency of Communication About Sex2.1 units on a scaleStandard Deviation 1.1
Alcohol (Teen)Frequency of Communication About Sex2.3 units on a scaleStandard Deviation 0.9
Sexual Health & Alcohol Control Group (Parent)Frequency of Communication About Sex1.8 units on a scaleStandard Deviation 0.8
Sexual Health and Alcohol Control Group (Teen)Frequency of Communication About Sex2.4 units on a scaleStandard Deviation 1
p-value: 0.505Generalized Linear Model
p-value: 0.176Generalized Linear Model
p-value: 0.134Generalized Linear Model
p-value: 0.029Generalized Linear Model
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).

Time frame: 6 months post-enrollment

Population: Parent Population

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Parent-teen Communication About Being a Safe Passenger2.55 units on a scaleStandard Deviation 0.67
Sexual Health (Teen)Parent-teen Communication About Being a Safe Passenger1.71 units on a scaleStandard Deviation 1.27
p-value: 0.008t-test, 2 sided
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).

Time frame: 6 months post-enrollment

Population: Parent Population

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Parent-teen Communication About Dangers of Distracted Driving2.77 units on a scaleStandard Deviation 0.43
Sexual Health (Teen)Parent-teen Communication About Dangers of Distracted Driving2.63 units on a scaleStandard Deviation 0.71
p-value: 0.394t-test, 2 sided
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).

Time frame: 6 months post-enrollment

Population: Parent Population

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Parent-teen Communication About Driving Under the Influence of Drugs or Alcohol1.73 units on a scaleStandard Deviation 1.16
Sexual Health (Teen)Parent-teen Communication About Driving Under the Influence of Drugs or Alcohol1.21 units on a scaleStandard Deviation 1.29
p-value: 0.159t-test, 2 sided
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).

Time frame: 6 months post-enrollment

Population: Parent Population

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Parent-teen Communication About Pennsylvania's Graduated Driver Licensing Laws1.82 units on a scaleStandard Deviation 0.85
Sexual Health (Teen)Parent-teen Communication About Pennsylvania's Graduated Driver Licensing Laws.71 units on a scaleStandard Deviation 1.08
p-value: <0.001t-test, 2 sided
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).

Time frame: 6 months post-enrollment

Population: Parent Population

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Parent-teen Communication About Reasons the Teen Wants to Drive2.32 units on a scaleStandard Deviation 0.89
Sexual Health (Teen)Parent-teen Communication About Reasons the Teen Wants to Drive1.75 units on a scaleStandard Deviation 0.9
p-value: 0.037t-test, 2 sided
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

Time frame: 6 months post-enrollment

Population: Parent Population

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Parent-teen Communication About Stopping a Friend From Driving Under the Influence of Drugs or Alcohol2.64 units on a scaleStandard Deviation 0.66
Sexual Health (Teen)Parent-teen Communication About Stopping a Friend From Driving Under the Influence of Drugs or Alcohol2.29 units on a scaleStandard Deviation 0.955
p-value: 0.165t-test, 2 sided
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).

Time frame: 6 months post-enrollment

Population: Parent Population

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Parent-teen Communication About Stopping a Friend From Riding With a Driver Who is Under the Influence of Drugs or Alcohol1.68 units on a scaleStandard Deviation 1.17
Sexual Health (Teen)Parent-teen Communication About Stopping a Friend From Riding With a Driver Who is Under the Influence of Drugs or Alcohol.71 units on a scaleStandard Deviation 1.12
p-value: 0.006t-test, 2 sided
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).

Time frame: 6 months post-enrollment

Population: Parent Population

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Parent-teen Communication About the Kinds of Risky Driving Situations That Might Come up in His or Her Friend Group2.59 units on a scaleStandard Deviation 0.73
Sexual Health (Teen)Parent-teen Communication About the Kinds of Risky Driving Situations That Might Come up in His or Her Friend Group1.79 units on a scaleStandard Deviation 0.98
p-value: 0.003t-test, 2 sided
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).

Time frame: 6 months post-enrollment

Population: Parent Population

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Parent-teen Communication About Wearing a Seatbelt2.68 units on a scaleStandard Deviation 0.72
Sexual Health (Teen)Parent-teen Communication About Wearing a Seatbelt2.79 units on a scaleStandard Deviation 0.59
p-value: 0.571t-test, 2 sided
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).

Time frame: 6 months post-enrollment

Population: Parent Population

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Parent-teen Communication About What to do if Stopped by a Police Officer2.27 units on a scaleStandard Deviation 0.88
Sexual Health (Teen)Parent-teen Communication About What to do if Stopped by a Police Officer1.25 units on a scaleStandard Deviation 1.07
p-value: 0.001t-test, 2 sided
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).

Time frame: 6 months post-enrollment

Population: Parent Population

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Parent-teen Communication About What to do if the Teen Needs a Safe Ride Home2.45 units on a scaleStandard Deviation 0.86
Sexual Health (Teen)Parent-teen Communication About What to do if the Teen Needs a Safe Ride Home1.96 units on a scaleStandard Deviation 1.2
p-value: 0.112t-test, 2 sided
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).

Time frame: 6 months post-enrollment

Population: Parent Population

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Parent-teen Communication About What to do in a Crash2.00 units on a scaleStandard Deviation 1.23
Sexual Health (Teen)Parent-teen Communication About What to do in a Crash.46 units on a scaleStandard Deviation 0.83
p-value: <0.001t-test, 2 sided
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, α parent = 0.84, and 43-96, α teen = 0.87.

Time frame: 4-6 months post-enrollment

Population: Arm 1 only. Parents and teens analyzed separately. Arm 2 (teen driving) had different primary outcomes (see outcomes 4-15) and therefore was not included here.

ArmMeasureValue (MEAN)Dispersion
Sexual Health (Parent)Quality of Parent-teen Communication (General- All Groups)77.8 units on a scaleStandard Deviation 10.5
Sexual Health (Teen)Quality of Parent-teen Communication (General- All Groups)73.0 units on a scaleStandard Deviation 9.4
Alcohol Prevention (Parent)Quality of Parent-teen Communication (General- All Groups)77.2 units on a scaleStandard Deviation 8.6
Alcohol (Teen)Quality of Parent-teen Communication (General- All Groups)69.1 units on a scaleStandard Deviation 8.4
Sexual Health & Alcohol Control Group (Parent)Quality of Parent-teen Communication (General- All Groups)77.4 units on a scaleStandard Deviation 10.3
Sexual Health and Alcohol Control Group (Teen)Quality of Parent-teen Communication (General- All Groups)68.6 units on a scaleStandard Deviation 11.1
p-value: 0.906Generalized Linear Model
p-value: 0.796Generalized Linear Model
p-value: 0.886Generalized Linear Model
p-value: 0.082Generalized Linear Model

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026