Family Based Prevention of Alcohol and Risky Sex for Older Teens
Sponsor
Pacific Institute for Research and Evaluation (Other)
Overall Status
Completed
CT.gov ID
NCT03521115
Collaborator
Klein Buendel, Inc. (Industry), University of New Mexico (Other)
411
1
2
49.9
8.2
Study Details
Study Description
Brief Summary
An online, interactive web-based program for older teens and their parents is designed to address teen alcohol use and teen relationships. The parent-teen dyad both participate in the web-based program and engage in off-line discussion activities. This intervention promotes communication skills, refusal skills, and helps teens consider how to make healthy choices. A total of 411 family dyads (one parent, one teen) were recruited.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This purpose of this study is to develop an interactive, web-based prevention program for parents and older teens that focuses on teen use of alcohol and teen relationships. The study is designed as a randomized controlled trial.
Specific Aim 1: To adapt two parent-based prevention strategies (Family Matters and Parent Handbook) to provide a family-based approach for addressing older teen alcohol related risk behaviors and sexual risk behaviors and sex in combination with alcohol use (hereafter called alcohol and/or sexual risk behaviors) using the web as the program delivery mode.
Specific Aim 2: To test whether exposure to the program leads to expected changes in targeted teen beliefs and behaviors, including reductions in alcohol and/or sexual risk behaviors.
Specific Aim 3: To examine whether program effects on teen alcohol and/or sexual risk behaviors are mediated through changes in intermediate program targeted beliefs (parents and teen) and behaviors (e.g., parent-teen--communication). Program fidelity and process measures may also mediate these outcomes.
Phase I integrates and adapts the two parent-based approaches and creates a web-based interactive delivery of materials. Expert panels, focus groups, and usability assessments will inform the process. Phase II is an RCT with 400 families with the web-based intervention. Surveys will be conducted at baseline, and for three follow-up periods (6, 12, & 18 months). Analyses will examine teen outcomes related to alcohol and/or sexual risk behaviors. Changes in mediators directly impacted by the program for both teens and parents will be examined. Process and fidelity information will be collected and assessed.
A web-based prevention strategy supporting parents and teens, is significant and timely. Parents and teens will use the internet to make health decisions. This program is uniquely different from other programs be-cause it addresses teens at high risk for alcohol and/or sexual risk behaviors. Further, the strategy involves both parents and teens through an interactive framework. The approach utilizes the strengths of Family Matters which promotes specific exercises and activities between parents and teens and the strengths of the Parent Handbook which addresses issues of importance to this age range.
Study Design
Study Type:
Interventional
Actual Enrollment
:
411 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
Single (Participant)
Masking Description:
Parents and Teens were either assigned to the full intervention or provided with didactic materials available on the internet. Family is considered the level of participant
Primary Purpose:
Prevention
Official Title:
Web-based Family Prevention of Alcohol and Risky Sex for Older Teens
Actual Study Start Date
:
Apr 1, 2013
Actual Primary Completion Date
:
May 28, 2017
Actual Study Completion Date
:
May 28, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Smart Choices 4 Teens A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Numbers are provided for the number of families |
Behavioral: Smart Choices 4 Teens
This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other.
|
| No Intervention: Control condition This group was provided with websites where information was available regarding the same topics. |
Outcome Measures
Primary Outcome Measures
- Number of Teens Using Any Alcohol During Past 6 Months [Measured at baseline, 6, 12, & 18 months]
Have you had a drink of alcohol in the past 6 months? (A drink is a glass of wine, a can of beer, a wine cooler, a shot glass of liquor, or a mixed drink). (Response category yes=1/no=0). Range is 0-1. More frequent drinking is a worse outcome.
- Frequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months [Measured at 6, 12, & 18 months]
Over the past 30 days, how many times have you had a drink of alcohol? (response categories: 0=none, 1=once, 2=2-3 times, 3= once a week, 4=2-3 times a week. Range is 0-4.Higher score is more frequent drinking and a worse outcome.
- Quantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months [Measured at baseline, 6, 12, & 18 months]
Over the past 30 days, how many drinks did you usually have on days you drank? (response categories: 0= less than one, 1, 2, 3, 4, 5, 6, 7= more than six). Range is 0-7. Higher scores represent more drinking and worse outcome.
- Count of Teens Who Were Drunk or Very, Very High During the Past 6 Months [Measured at 6, 12, & 18 months]
Over the past 6 months, how many times have you gotten drunk or very, very high on alcohol? (Response categories: 0=none, 1=once a month, 2=2-3 times a month, 3=once a week, 4= 2-3 times a week, 5=daily or almost daily). Range is 0-5. Higher score represents more drunkenness and a worse outcome.
- Frequency of Parental Approval for Teen Drinking (in Moderation) [Measured at baseline, 6, 12, & 18 months]
How often have you and your parent talked about drinking in moderation is okay (Response categories 1=Never, 2=Occasionally, 3=Sometimes, 4= Often, 5 = Very often). Range is 1-5 and higher scores means more parental approval of teen drinking and is a worse outcome.
- Frequency of Teen- Parent Communications Regarding Sex [Measured at baseline, 6, 12, & 18 months]
Overall, how often you have talked to your parent about sex? (1=Never, 2=Occasionally, 3=Sometimes, 4=Often, 5= Very often). Range 1-5. Higher scores represent a better outcome.
- Frequency of Teen-parent Communications About Specific Sexual Topics [Measured at baseline, 6, 12, & 18 months]
Average frequency created across 4 different sex topics (i. how being in a relationship might divert me from achieving my goals at school, ii. how embarrassing it would be if I caught an STI -sexually transmitted infection, iii. sexual relationships can impact health, iv. how pregnancy would be embarassing) with responses being never=1, occasionally=2, sometimes=3, often=4, very often=5. Range is 4-20 and average created by dividing the score by 4, with higher scores indicating more both topics and higher frequency of discussions taking place.
- Count of Teen-parent Communications Regarding Delaying Sexual Activity [Measured at baseline, 6, 12, & 18 months]
Communications regarding delaying sex based upon three questions with yes=1/no=0 responses summed: Have your parents told you that (i)you should not have sex, (ii)you should not be in a serious relationship while still in high school, (iii)you should not have sex because your religion or values forbid sex outside of marriage. Higher scores indicate more communications about delaying sex. Range is 0-3. Higher scores represent a better outcome.
- Count of Teen-parent Communications Regarding Health Risks Associated With Sex [Past 6, 12, & 18 months]
Parent-teen communications score regarding health risks with sex were based upon two items: discussion that sex can result in pregnancy (y=1/n=0) and sex can result in sexually transmitted infections (y=1/n=0). Range is 0-2. Higher scores represent a better outcome.
- Count of Parental Dating Rules [Measured at baseline, 6, 12, & 18 months]
Parental rules regarding dating were based upon summing the yes (=1) response to 15 possible rules: parents must meet date, check in/call during date, parents must know destination, parents must know change of plans, address and phone number needed for parties, no dates on school nights, no sex, no sigle dates, curfew, only agreed upon locations, use good judgment, be gentleman/lady, leave if uncomfortable (y=1/n=0). Range is 0-15. Higher scores represent better outcomes.
- Count of Teens Who Have Ever Had Sex Over Their Lifetime [Measured at baseline, 6, 12, & 18 months]
Have you ever had sex (vaginal, oral, or anal)? (responses were yes=1/no=0). Range was 0-1. Higher score is worse outcome risk.
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- One parent and the teen both had to enroll in the study.
Exclusion Criteria:
- Non-English speaking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brenda Miller | Berkeley | California | United States | 94704-1365 |
Sponsors and Collaborators
- Pacific Institute for Research and Evaluation
- Klein Buendel, Inc.
- University of New Mexico
Investigators
- Principal Investigator: Brenda A Miller, Ph.D., Pacific Institute for Research & Evaluation
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Brenda Miller,
Senior Scientist,
Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier:
NCT03521115
Other Study ID Numbers:
- AA020977
First Posted:
May 11, 2018
Last Update Posted:
Oct 12, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | November 2014-November 2015 Recruited national sample from two panel vendors |
|---|---|
| Pre-assignment Detail | To be eligible, one teen and one parent had to be willing to participate. Enrollment was considered complete after the participants completed consent and baseline surveys. A total of 559 families were eligible and 148 of eligible families declined to participate, leaving a total of 411 families. |
| Arm/Group Title | Smart Choices 4 Teens | Control Condition |
|---|---|---|
| Arm/Group Description | A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other. | This group was provided with websites where information was available regarding the same topics. |
| Period Title: Time 0 Baseline Surveys | ||
| STARTED | 206 | 205 |
| COMPLETED | 206 | 205 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Time 0 Baseline Surveys | ||
| STARTED | 206 | 205 |
| COMPLETED | 150 | 165 |
| NOT COMPLETED | 56 | 40 |
| Period Title: Time 0 Baseline Surveys | ||
| STARTED | 150 | 165 |
| COMPLETED | 147 | 164 |
| NOT COMPLETED | 3 | 1 |
| Period Title: Time 0 Baseline Surveys | ||
| STARTED | 147 | 164 |
| COMPLETED | 145 | 164 |
| NOT COMPLETED | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | Smart Choices 4 Teens | Control Condition | Total |
|---|---|---|---|
| Arm/Group Description | A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other. | This group was provided with websites where information was available regarding the same topics. | Total of all reporting groups |
| Overall Participants | 206 | 205 | 411 |
| Age (years) [Mean (Standard Deviation) ] | |||
| parent age |
43.73
(7.039)
|
43.75
(6.385)
|
43.74
(6.711)
|
| teen age |
16.40
(.492)
|
16.34
(.474)
|
16.37
(.483)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
173
84%
|
175
85.4%
|
348
84.7%
|
| Male |
33
16%
|
30
14.6%
|
63
15.3%
|
| Female |
109
52.9%
|
117
57.1%
|
226
55%
|
| Male |
96
46.6%
|
87
42.4%
|
183
44.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
16
7.8%
|
14
6.8%
|
30
7.3%
|
| Not Hispanic or Latino |
190
92.2%
|
190
92.7%
|
380
92.5%
|
| Unknown or Not Reported |
0
0%
|
1
0.5%
|
1
0.2%
|
| Hispanic or Latino |
21
10.2%
|
14
6.8%
|
35
8.5%
|
| Not Hispanic or Latino |
179
86.9%
|
190
92.7%
|
369
89.8%
|
| Unknown or Not Reported |
6
2.9%
|
1
0.5%
|
7
1.7%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
2
1%
|
1
0.5%
|
3
0.7%
|
| Asian |
4
1.9%
|
4
2%
|
8
1.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
0.5%
|
1
0.2%
|
| Black or African American |
24
11.7%
|
24
11.7%
|
48
11.7%
|
| White |
161
78.2%
|
157
76.6%
|
318
77.4%
|
| More than one race |
13
6.3%
|
11
5.4%
|
24
5.8%
|
| Unknown or Not Reported |
2
1%
|
7
3.4%
|
9
2.2%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
206
100%
|
205
100%
|
411
100%
|
| Any Alcohol Use (Count of Participants) | |||
| Count of Participants [Participants] |
21
10.2%
|
26
12.7%
|
47
11.4%
|
| Frequency of Alcohol Use (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
.21
(.59)
|
.17
(.54)
|
.19
(.57)
|
| Quantity of alcohol consumed on drinking days (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
.27
(.93)
|
.26
(1.05)
|
.27
(.99)
|
| Number of times drunk or very, very high (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
.29
(.89)
|
.24
(.74)
|
.26
(.82)
|
| Parental approval of teen drinking (in moderation) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
2.05
(1.36)
|
2.08
(1.30)
|
2.07
(1.33)
|
| Overall communication about sex (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
2.65
(1.05)
|
2.55
(1.11)
|
2.60
(1.08)
|
| Frequency for Topic Specific sexual activity (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
2.68
(1.06)
|
2.62
(1.09)
|
2.62
(1.09)
|
| Communications regarding delaying sex (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
1.23
(1.03)
|
1.33
(1.10)
|
1.28
(1.07)
|
| Communication regarding health risks (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
1.85
(0.46)
|
1.81
(0.53)
|
1.83
(0.50)
|
| Number of Dating rules (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
11.19
(3.16)
|
11.32
(3.10)
|
11.26
(3.12)
|
| Ever had sex (Count of Participants) | |||
| Count of Participants [Participants] |
55
26.7%
|
48
23.4%
|
103
25.1%
|
Outcome Measures
| Title | Number of Teens Using Any Alcohol During Past 6 Months |
|---|---|
| Description | Have you had a drink of alcohol in the past 6 months? (A drink is a glass of wine, a can of beer, a wine cooler, a shot glass of liquor, or a mixed drink). (Response category yes=1/no=0). Range is 0-1. More frequent drinking is a worse outcome. |
| Time Frame | Measured at baseline, 6, 12, & 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some teens were lost at follow-up |
| Arm/Group Title | Smart Choices 4 Teens | Assigned Intervention, no Exposures | Control Condition |
|---|---|---|---|
| Arm/Group Description | A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other. | Assigned to intervention but had no exposure to alcohol component of the intervention. | This group received information that was available on an NIAAA website |
| Measure Participants | 99 | 101 | 201 |
| at 6 month follow-up |
16
7.8%
|
20
9.8%
|
38
9.2%
|
| at 12 month follow-up |
14
6.8%
|
23
11.2%
|
43
10.5%
|
| at 18 month follow-up |
26
12.6%
|
24
11.7%
|
47
11.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | 6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | b=-.91, controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, & race. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | .40 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | 12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.10 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | .58 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, & race. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | 18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .077 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Chi-Square |
| Estimated Value | 5.129 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Frequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months |
|---|---|
| Description | Over the past 30 days, how many times have you had a drink of alcohol? (response categories: 0=none, 1=once, 2=2-3 times, 3= once a week, 4=2-3 times a week. Range is 0-4.Higher score is more frequent drinking and a worse outcome. |
| Time Frame | Measured at 6, 12, & 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Missing responses and teens lost at follow-up |
| Arm/Group Title | Smart Choices 4 Teens | Assigned Experimental, No Exposure | Control Condition |
|---|---|---|---|
| Arm/Group Description | A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other. | Assigned experimental, No exposure to alcohol component of intervention | This group was provided with websites where information was available regarding the same topics. |
| Measure Participants | 97 | 100 | 201 |
| 6 month follow-up |
.16
(.56)
|
.43
(.95)
|
.21
(.62)
|
| 12 month follow-up |
.09
(.36)
|
.48
(.99)
|
.30
(.82)
|
| 18 month follow-up |
.31
(.69)
|
.29
(.64)
|
.43
(.93)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | 6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | Controled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, & race. | |
| Method of Estimation | Estimation Parameter | b |
| Estimated Value | -.47 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | 12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, & race. | |
| Method of Estimation | Estimation Parameter | b |
| Estimated Value | -.97 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | 18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.10 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | F |
| Estimated Value | .85 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Quantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months |
|---|---|
| Description | Over the past 30 days, how many drinks did you usually have on days you drank? (response categories: 0= less than one, 1, 2, 3, 4, 5, 6, 7= more than six). Range is 0-7. Higher scores represent more drinking and worse outcome. |
| Time Frame | Measured at baseline, 6, 12, & 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cases lost to follow-up and for missing data. |
| Arm/Group Title | Smart Choices 4 Teens | Assigned Experimental, No Exposure | Control Condition |
|---|---|---|---|
| Arm/Group Description | A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other. | Assigned experimental, No exposure to alcohol component of intervention | This group was provided with websites where information was available regarding the same topics. |
| Measure Participants | 97 | 100 | 201 |
| 6 month follow-up |
.16
(.64)
|
.46
(1.22)
|
.32
(1.13)
|
| 12 month follow-up |
.13
(.64)
|
.61
(1.28)
|
.40
(1.13)
|
| 18 month follow-up |
.46
(1.18)
|
.45
(1.26)
|
.60
(1.48)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | 6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.10 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | b |
| Estimated Value | -.22 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, & race. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | 12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | b |
| Estimated Value | -.24 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, & race. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | 18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.10 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | F |
| Estimated Value | 0.43 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Count of Teens Who Were Drunk or Very, Very High During the Past 6 Months |
|---|---|
| Description | Over the past 6 months, how many times have you gotten drunk or very, very high on alcohol? (Response categories: 0=none, 1=once a month, 2=2-3 times a month, 3=once a week, 4= 2-3 times a week, 5=daily or almost daily). Range is 0-5. Higher score represents more drunkenness and a worse outcome. |
| Time Frame | Measured at 6, 12, & 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Within the experimental group, 49.5% completed the alcohol component of the intervention |
| Arm/Group Title | Smart Choices 4 Teens | Assigned Experimental, no Exposure | Control Condition |
|---|---|---|---|
| Arm/Group Description | A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other. | This group had no exposure to the intervention relating to sexual communication and behaviors | This group was provided with websites where information was available regarding the same topics. |
| Measure Participants | 99 | 100 | 201 |
| 6 month follow-up |
.10
(.40)
|
.26
(.96)
|
.23
(.91)
|
| 12 month follow-up |
.08
(.35)
|
.44
(1.46)
|
.39
(1.20)
|
| 18 month follow-up |
.21
(.61)
|
.26
(1.00)
|
.45
(1.30)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | 6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.10 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, & race. | |
| Method of Estimation | Estimation Parameter | b |
| Estimated Value | -.16 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | 12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, & race. | |
| Method of Estimation | Estimation Parameter | b |
| Estimated Value | -.26 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | 18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.10 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | F |
| Estimated Value | 1.550 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Frequency of Parental Approval for Teen Drinking (in Moderation) |
|---|---|
| Description | How often have you and your parent talked about drinking in moderation is okay (Response categories 1=Never, 2=Occasionally, 3=Sometimes, 4= Often, 5 = Very often). Range is 1-5 and higher scores means more parental approval of teen drinking and is a worse outcome. |
| Time Frame | Measured at baseline, 6, 12, & 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Across time, there was loss of sample at follow-up |
| Arm/Group Title | Smart Choices 4 Teens | Assigned Intervention, no Exposures | Control Condition |
|---|---|---|---|
| Arm/Group Description | A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other. | Assigned to intervention but had no exposure to alcohol component of the intervention. | This group received information that was available on an NIAAA website |
| Measure Participants | 101 | 101 | 203 |
| 6 month follow-up |
1.99
(1.31)
|
2.59
(1.40)
|
2.26
(1.35)
|
| 12 month follow-up |
2.16
(1.29)
|
2.66
(1.55)
|
2.19
(1.27)
|
| 18 month follow-up |
2.12
(1.40)
|
2.57
(1.31)
|
2.13
(1.28)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | 6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | b |
| Estimated Value | -.35 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, & race. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | 12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.10 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | b |
| Estimated Value | -.02 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, & race. | |
| Title | Frequency of Teen- Parent Communications Regarding Sex |
|---|---|
| Description | Overall, how often you have talked to your parent about sex? (1=Never, 2=Occasionally, 3=Sometimes, 4=Often, 5= Very often). Range 1-5. Higher scores represent a better outcome. |
| Time Frame | Measured at baseline, 6, 12, & 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The rows represent 3 different follow-up periods and the number of cases analyzed varied because the responses at follow-up varied. |
| Arm/Group Title | Smart Choices 4 Teens | Assigned Intervention, no Exposure | Control Condition |
|---|---|---|---|
| Arm/Group Description | A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other. | This group was assigned to the intervention but had no exposure to the relationship component of the intervention. | This group was provided with websites where information was available regarding the same topics. |
| Measure Participants | 81 | 67 | 165 |
| 6 month follow |
2.46
(0.99)
|
2.18
(1.28)
|
2.19
(1.20)
|
| 12 month follow up |
2.45
(1.17)
|
2.02
(1.09)
|
2.23
(1.16)
|
| 18 month follow-up |
2.46
(1.17)
|
1.97
(1.08)
|
2.07
(1.04)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | generalized estimating equations | |
| Comments | ||
| Method of Estimation | Estimation Parameter | b |
| Estimated Value | .299 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, & race. | |
| Title | Frequency of Teen-parent Communications About Specific Sexual Topics |
|---|---|
| Description | Average frequency created across 4 different sex topics (i. how being in a relationship might divert me from achieving my goals at school, ii. how embarrassing it would be if I caught an STI -sexually transmitted infection, iii. sexual relationships can impact health, iv. how pregnancy would be embarassing) with responses being never=1, occasionally=2, sometimes=3, often=4, very often=5. Range is 4-20 and average created by dividing the score by 4, with higher scores indicating more both topics and higher frequency of discussions taking place. |
| Time Frame | Measured at baseline, 6, 12, & 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed varies across rows because the rows represent different follow-up periods and participation varied across follow-ups. |
| Arm/Group Title | Smart Choices 4 Teens | Assigned Intervention, no Exposure | Control Condition |
|---|---|---|---|
| Arm/Group Description | A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other. | This group was assigned to the intervention but had no exposure to the relationship component of the intervention. | This group was provided with websites where information was available regarding the same topics. |
| Measure Participants | 82 | 67 | 164 |
| Frequency of sexual communication at 6 month follow-up |
2.60
(1.11)
|
2.23
(1.06)
|
2.27
(1.10)
|
| Frequency of sexual communication at 12 month follow-up |
2.50
(1.12)
|
2.03
(0.93)
|
2.36
(1.11)
|
| Frequency of sexual communication at 18 month follow-up |
2.47
(1.10)
|
2.50
(1.12)
|
2.23
(1.06)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.03 |
| Comments | ||
| Method | generalized estimating equations | |
| Comments | ||
| Method of Estimation | Estimation Parameter | b |
| Estimated Value | .268 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Count of Teen-parent Communications Regarding Delaying Sexual Activity |
|---|---|
| Description | Communications regarding delaying sex based upon three questions with yes=1/no=0 responses summed: Have your parents told you that (i)you should not have sex, (ii)you should not be in a serious relationship while still in high school, (iii)you should not have sex because your religion or values forbid sex outside of marriage. Higher scores indicate more communications about delaying sex. Range is 0-3. Higher scores represent a better outcome. |
| Time Frame | Measured at baseline, 6, 12, & 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The three rows represent different follow-up periods and there are different response rates across follow-up periods. |
| Arm/Group Title | Smart Choices 4 Teens | Assigned Intervention, no Exposure | Control Condition |
|---|---|---|---|
| Arm/Group Description | A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other. | This group was assigned to the intervention but had no exposure to the relationship component of the intervention. | This group was provided with websites where information was available regarding the same topics. |
| Measure Participants | 82 | 66 | 164 |
| Communication regarding delay sex at 6 month follow-up |
1.13
(1.09)
|
0.85
(0.98)
|
0.98
(1.04)
|
| Communication regarding delay sex at 12 month follow-up |
1.09
(1.11)
|
1.02
(1.08)
|
1.07
(1.10)
|
| Communication regarding delay sex at 18 month follow-up |
0.98
(1.04)
|
0.75
(1.00)
|
0.95
(1.11)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.10 |
| Comments | ||
| Method | generalized estimating equations | |
| Comments | ||
| Method of Estimation | Estimation Parameter | b |
| Estimated Value | .075 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, & race. | |
| Title | Count of Teen-parent Communications Regarding Health Risks Associated With Sex |
|---|---|
| Description | Parent-teen communications score regarding health risks with sex were based upon two items: discussion that sex can result in pregnancy (y=1/n=0) and sex can result in sexually transmitted infections (y=1/n=0). Range is 0-2. Higher scores represent a better outcome. |
| Time Frame | Past 6, 12, & 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Each row represents a different follow-up time period and the number of respondents varied across the time periods. |
| Arm/Group Title | Smart Choices 4 Teens | Assigned Intervention, no Exposure | Control Condition |
|---|---|---|---|
| Arm/Group Description | A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other. | This group was assigned to the intervention but had no exposure to the relationship component of the intervention. | This group was provided with websites where information was available regarding the same topics. |
| Measure Participants | 88 | 65 | 164 |
| Communications on Health Risks at 6 month follow-up |
1.63
(0.71)
|
1.35
(0.89)
|
1.51
(.77)
|
| Communications on Health Risks at 12 month Follow-up |
1.53
(0.77)
|
1.40
(0.86)
|
1.54
(0.79)
|
| Communications on Health Risk at 18 month follow-up |
1.49
(0.83)
|
1.27
(0.90)
|
1.38
(0.86)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.10 |
| Comments | ||
| Method | generalized estimating equations | |
| Comments | ||
| Method of Estimation | Estimation Parameter | b |
| Estimated Value | 0.051 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, & race. | |
| Title | Count of Parental Dating Rules |
|---|---|
| Description | Parental rules regarding dating were based upon summing the yes (=1) response to 15 possible rules: parents must meet date, check in/call during date, parents must know destination, parents must know change of plans, address and phone number needed for parties, no dates on school nights, no sex, no sigle dates, curfew, only agreed upon locations, use good judgment, be gentleman/lady, leave if uncomfortable (y=1/n=0). Range is 0-15. Higher scores represent better outcomes. |
| Time Frame | Measured at baseline, 6, 12, & 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| There are 3 follow-up periods and the numbers analyzed vary across these follow-up periods |
| Arm/Group Title | Smart Choices 4 Teens | Assigned Intervention, no Exposure | Control Condition |
|---|---|---|---|
| Arm/Group Description | A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other. | This group was assigned to the intervention but had no exposure to the relationship component of the intervention. | This group was provided with websites where information was available regarding ... |
| Measure Participants | 82 | 65 | 163 |
| Dating Rules-Teen report 6 month follow-up |
11.48
(2.97)
|
10.18
(3.91)
|
10.77
(3.57)
|
| Dating rules, teen report, 12 month follow-up |
11.04
(3.47)
|
10.42
(3.57)
|
10.72
(3.44)
|
| Dating rules, teen report, 18 month follow-up |
11.01
(3.29)
|
9.53
(3.59)
|
10.08
(4.09)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | generalized estimating equations | |
| Comments | ||
| Method of Estimation | Estimation Parameter | b |
| Estimated Value | 0.72 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Count of Teens Who Have Ever Had Sex Over Their Lifetime |
|---|---|
| Description | Have you ever had sex (vaginal, oral, or anal)? (responses were yes=1/no=0). Range was 0-1. Higher score is worse outcome risk. |
| Time Frame | Measured at baseline, 6, 12, & 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The three rows reflect different follow-up periods, teens were lost to follow-up in subsequent waves |
| Arm/Group Title | Smart Choices 4 Teens | Assigned Intervention, no Exposure | Control Condition |
|---|---|---|---|
| Arm/Group Description | A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other. | This group was assigned to the intervention but had no exposure to the relationship component of the intervention. | This group was provided with websites where information was available regarding the same topics. |
| Measure Participants | 60 | 50 | 122 |
| ever had sex at 6 month follow-up |
17
8.3%
|
15
7.3%
|
37
9%
|
| ever had sex at 12 month follow-up |
17
8.3%
|
20
9.8%
|
39
9.5%
|
| ever had sex at 18 month follow-up |
19
9.2%
|
21
10.2%
|
46
11.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Smart Choices 4 Teens, Assigned Intervention, no Exposures, Control Condition |
|---|---|---|
| Comments | Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.10 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Adverse Events
| Time Frame | Over three years of the study | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | None of the parents or teens were exposed to any experimental condition that threatened life. There was not physical or medical intervention. This was a prevention program that was designed to address behavioral health issues. | |||
| Arm/Group Title | Smart Choices 4 Teens | Control Condition | ||
| Arm/Group Description | A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other. | This group was provided with websites where information was available regarding the same topics. | ||
All Cause Mortality |
||||
| Smart Choices 4 Teens | Control Condition | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/206 (0%) | 0/205 (0%) | ||
Serious Adverse Events |
||||
| Smart Choices 4 Teens | Control Condition | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/206 (0%) | 0/205 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Smart Choices 4 Teens | Control Condition | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/206 (0%) | 0/205 (0%) | ||
Limitations/Caveats
This sample was drawn from a nationwide sample of families compiled by panel vendors. Smart Choices 4 Teens is family-based, designed to promote healthy choices by teens related to alcohol use and relationships. It is not a treatment program.
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Brenda A. Miller |
|---|---|
| Organization | PIRE |
| Phone | 5105205889 |
| BMiller@prev.org |
Responsible Party:
Brenda Miller,
Senior Scientist,
Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier:
NCT03521115
Other Study ID Numbers:
- AA020977
First Posted:
May 11, 2018
Last Update Posted:
Oct 12, 2021
Last Verified:
Sep 1, 2021