Skip to content

Preventing Drug Abuse Among Sexual Minority Youth

Preventing Drug Abuse Among Sexual-Minority Youth

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03954535
Enrollment
1216
Registered
2019-05-17
Start date
2020-01-15
Completion date
2024-03-30
Last updated
2025-08-26

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

Conditions

Substance Abuse

Keywords

sexual minorities, prevention, web-based intervention, substance use, longitudinal, randomized controlled trial, adolescence

Brief summary

The planned randomized clinical trial will longitudinally test a tailored, web-based drug abuse prevention program with a nationwide sample of 15- to 17-year-old sexual minority youth (youth who identify as gay, lesbian, bisexual, or unsure of their sexual orientation).

Detailed description

The randomized controlled trial will include at least 890 sexual-minority youth from the United States. Study participants will be 15- to 17-year-old youth recruited from Facebook/Instagram. All youth will complete pretest measures online. Intervention-arm youth will then interact with the 9-session program; youth in the control arm will have access to an attention-placebo website. All youth will then complete posttest measures (immediately following intervention completion and estimated to be approximately 5 months after study onset) and 1-, 2-, and 3-year follow-up measures. Across posttest and annual follow-up measurement occasions, data analyses will examine rates of 30-day drug use between study arms. The investigators will also examine intervention effects on mediator variables associated with drug use and assess the extent to which changes in mediator variables explain differences in drug use between arms. Youth assigned to the intervention arm will have access to 9 intervention sessions delivered online. The sessions will be housed on a website with entertainment features youth seek: life hacks, features on LGBTQ leaders, fortunes, horoscopes, inspiring quotes, and health-related resources. To ensure that youths' expectations for study participation are equivalent across arms and to account for the non-active components of the experimental intervention, the investigators designed the attention-placebo arm. Youth assigned to the attention-placebo arm will have access to the website with entertainment features: life hacks, features on LGBTQ leaders, fortunes, horoscopes, inspiring quotes, and health-related resources.

Interventions

BEHAVIORALFree2b

The intervention will consist of a website and 9 sessions. The intervention sessions will facilitate youths' acquisition of personal and social cognitive-behavioral skills. The intervention will focus on goal setting, decision making, enhancing self-worth, coping with stress, combating distorted thinking, communication skills, using alcohol and other drugs and a review session. Each session will require approximately 20 minutes and must be finished in a single sitting. Sessions will be delivered on a weekly basis. The website will include entertainment features and resources.

BEHAVIORALAttention-Placebo

Access to the website with entertainment features and resources - but no session content.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

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

Inclusion criteria

* teenagers between the ages of 15-17 years old * identify as lesbian, gay, bisexual, or unsure of sexual orientation * speak and read English * access to a private desktop, laptop, or tablet with broadband internet access Exclusion: \- Lives outside the United States of America

Design outcomes

Primary

MeasureTime frameDescription
Average Number of Times Youth Drank Alcohol in the Past Monthan average of 5 months from study onsetParticipants will be asked to report the numbers of times they have used the substance in the past month.
Average Number of Times Youth Binge Drank in the Past Monthan average of 5 months from study onsetParticipants will be asked to report the numbers of times they have used the substance in the past month.
Average Number of Times Youth Smoked Cigarettes in the Past Monthan average of 5 months from study onsetParticipants will be asked to report the numbers of times they have used the substance in the past month.
Average Number of Times Youth Smoked Marijuana in the Past Monthan average of 5 months from study onsetParticipants will be asked to report the numbers of times they have used the substance in the past month.
Average Number of Times Youth Vaped Any Substance in the Past Monthan average of 5 months from study onsetParticipants will be asked to report the numbers of times they have used the substance in the past month.
Average Number of Times Youth Used Hard Drugs in the Past Monthan average of 5 months from study onsetParticipants will be asked to report the numbers of times they have used the substance in the past month.

Secondary

MeasureTime frameDescription
Mean Scores for Self-Efficacyan average of 5 months from study onsetThe self-efficacy scale is a 7-item measuring youths' perceived ability to handle difficult life situations. All items are averaged to yield a total score that ranges from 0 = high self-efficacy to 4 = low self-efficacy; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Mean Scores for Drug Refusal Skillsan average of 5 months from study onsetThe drug refusal scale is a 15-item measure assessing the likelihood of youth using various refusal strategies when offered to use alcohol, cigarettes, or marijuana. All items are averaged to yield a total score that ranges from 1 = high refusal skills to 5 = poor refusal skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Mean Scores for Goal Settingan average of 5 months from study onsetThe goal setting scale is a 5-item measure assessing the degree to which youth set and work on goals. All items are averaged to yield a total score that ranges from 0 = low goal setting to 3 = higher goal setting; higher scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.
Mean Scores for Consequences of Substance Usean average of 5 months from study onsetThe consequences of substance use scale is a 13-item measure assessing how often youths' substance use has caused them trouble with the law, family, friends, and academics. All items are averaged to yield a total score that ranges from 0 = zero times to 10 = ten or more times; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Mean Scores for Assertivenessan average of 5 months from study onsetThe assertiveness scale is a 3-item measure assessing how well youth believe they assert themselves. All items are averaged to yield a total score that ranges from 1 = low assertiveness to 5 = high assertiveness; higher scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Mean Scores for Problem Solvingan average of 5 months from study onsetThe problem solving scale is an 8-item measure assessing the degree to which youth employ skills to solve problems. All items are averaged to yield a total score that ranges from 1 = high problem solving to 4 = low problem solving; lower scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.
Mean Scores for Self-Esteeman average of 5 months from study onsetThe self-esteem scale is a 10-item measure assessing youths' feelings of self-worth and value. All items are averaged to yield a total score that ranges from 1 = higher self-esteem to 4 = lower self-esteem; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Mean Scores for Perceived Stressan average of 5 months from study onsetThe perceived stress scale is an 8-item measure assessing the degree to which youth feel overwhelmed by stress. All items are averaged to yield a total score that ranges from 0 = low perceived stress to 5 = high perceived stress; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Mean Scores for Copingan average of 5 months from study onsetThe coping scale is a 6-item measure assessing the degree to which youth feel they can manage the difficulties in their life. All items are averaged to yield a total score that ranges from 0 = high coping skills to 3 = poor coping skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Mean Scores for Peer Drug Usean average of 5 months from study onsetThe peer drug use scale is a 7-item measuring that asks youth to indicate the number of close friends who have used various substances in the past month. All items are averaged to yield a total score that ranges from 0 = no peer use to 3 = all peers use; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention
9 sessions and website with entertainment features and resources Free2b: The intervention will consist of a website and 9 sessions. The intervention sessions will facilitate youths' acquisition of personal and social cognitive-behavioral skills. The intervention will focus on goal setting, decision making, enhancing self-worth, coping with stress, combating distorted thinking, communication skills, using alcohol and other drugs and a review session. Each session will require approximately 20 minutes and must be finished in a single sitting. Sessions will be delivered on a weekly basis. The website will include entertainment features and resources.
602
Control
website with entertainment features and resources Attention-Placebo: Access to the website with entertainment features and resources - but no session content.
606
Total1,208

Baseline characteristics

CharacteristicInterventionControlTotal
Age, Categorical
<=18 years
602 Participants606 Participants1208 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous16.15 years
STANDARD_DEVIATION 0.57
16.16 years
STANDARD_DEVIATION 0.56
16.16 years
STANDARD_DEVIATION 0.56
Ethnicity (NIH/OMB)
Hispanic or Latino
115 Participants112 Participants227 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
482 Participants492 Participants974 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants2 Participants7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
6 Participants10 Participants16 Participants
Race (NIH/OMB)
Asian
43 Participants34 Participants77 Participants
Race (NIH/OMB)
Black or African American
39 Participants56 Participants95 Participants
Race (NIH/OMB)
More than one race
163 Participants126 Participants289 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
5 Participants5 Participants10 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants2 Participants7 Participants
Race (NIH/OMB)
White
341 Participants373 Participants714 Participants
Region of Enrollment
United States
602 Participants606 Participants1208 Participants
Sex/Gender, Customized
Gender Identity
Female
339 Participants331 Participants670 Participants
Sex/Gender, Customized
Gender Identity
Gender fluid
24 Participants18 Participants42 Participants
Sex/Gender, Customized
Gender Identity
Male
107 Participants113 Participants220 Participants
Sex/Gender, Customized
Gender Identity
Non-binary
74 Participants73 Participants147 Participants
Sex/Gender, Customized
Gender Identity
Not sure
30 Participants39 Participants69 Participants
Sex/Gender, Customized
Gender Identity
Transgender
28 Participants32 Participants60 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 6080 / 608
other
Total, other adverse events
0 / 6080 / 608
serious
Total, serious adverse events
0 / 6080 / 608

Outcome results

Primary

Average Number of Times Youth Binge Drank in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Binge Drank in the Past Month0.50 number of timesStandard Deviation 1.38
Attention-Placebo ControlAverage Number of Times Youth Binge Drank in the Past Month0.59 number of timesStandard Deviation 1.6
Primary

Average Number of Times Youth Binge Drank in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Binge Drank in the Past Month0.65 number of timesStandard Deviation 1.64
Attention-Placebo ControlAverage Number of Times Youth Binge Drank in the Past Month0.78 number of timesStandard Deviation 2.41
Primary

Average Number of Times Youth Binge Drank in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Binge Drank in the Past Month0.18 number of timesStandard Deviation 0.88
Attention-Placebo ControlAverage Number of Times Youth Binge Drank in the Past Month0.25 number of timesStandard Deviation 0.97
Primary

Average Number of Times Youth Binge Drank in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Binge Drank in the Past Month0.35 number of timesStandard Deviation 1.05
Attention-Placebo ControlAverage Number of Times Youth Binge Drank in the Past Month0.32 number of timesStandard Deviation 0.97
Primary

Average Number of Times Youth Drank Alcohol in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Drank Alcohol in the Past Month1.93 number of timesStandard Deviation 3.91
Attention-Placebo ControlAverage Number of Times Youth Drank Alcohol in the Past Month2.30 number of timesStandard Deviation 4.74
Primary

Average Number of Times Youth Drank Alcohol in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Drank Alcohol in the Past Month1.22 number of timesStandard Deviation 2.49
Attention-Placebo ControlAverage Number of Times Youth Drank Alcohol in the Past Month1.37 number of timesStandard Deviation 2.64
Primary

Average Number of Times Youth Drank Alcohol in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Drank Alcohol in the Past Month0.83 number of timesStandard Deviation 2.12
Attention-Placebo ControlAverage Number of Times Youth Drank Alcohol in the Past Month1.03 number of timesStandard Deviation 2.26
Primary

Average Number of Times Youth Drank Alcohol in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Drank Alcohol in the Past Month2.49 number of timesStandard Deviation 4.86
Attention-Placebo ControlAverage Number of Times Youth Drank Alcohol in the Past Month2.67 number of timesStandard Deviation 5.72
Primary

Average Number of Times Youth Smoked Cigarettes in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Smoked Cigarettes in the Past Month0.31 number of timesStandard Deviation 3.23
Attention-Placebo ControlAverage Number of Times Youth Smoked Cigarettes in the Past Month0.39 number of timesStandard Deviation 4.29
Primary

Average Number of Times Youth Smoked Cigarettes in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Smoked Cigarettes in the Past Month0.50 number of timesStandard Deviation 4.11
Attention-Placebo ControlAverage Number of Times Youth Smoked Cigarettes in the Past Month0.48 number of timesStandard Deviation 3.74
Primary

Average Number of Times Youth Smoked Cigarettes in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Smoked Cigarettes in the Past Month0.70 number of timesStandard Deviation 5.23
Attention-Placebo ControlAverage Number of Times Youth Smoked Cigarettes in the Past Month0.79 number of timesStandard Deviation 5.67
Primary

Average Number of Times Youth Smoked Cigarettes in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year-follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Smoked Cigarettes in the Past Month0.76 number of timesStandard Deviation 5.27
Attention-Placebo ControlAverage Number of Times Youth Smoked Cigarettes in the Past Month1.05 number of timesStandard Deviation 6.61
Primary

Average Number of Times Youth Smoked Marijuana in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Smoked Marijuana in the Past Month2.43 number of timesStandard Deviation 10.23
Attention-Placebo ControlAverage Number of Times Youth Smoked Marijuana in the Past Month1.89 number of timesStandard Deviation 7.54
Primary

Average Number of Times Youth Smoked Marijuana in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Smoked Marijuana in the Past Month4.64 number of timesStandard Deviation 13.67
Attention-Placebo ControlAverage Number of Times Youth Smoked Marijuana in the Past Month3.71 number of timesStandard Deviation 12.03
Primary

Average Number of Times Youth Smoked Marijuana in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Smoked Marijuana in the Past Month7.12 number of timesStandard Deviation 17.53
Attention-Placebo ControlAverage Number of Times Youth Smoked Marijuana in the Past Month7.04 number of timesStandard Deviation 17.07
Primary

Average Number of Times Youth Smoked Marijuana in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Smoked Marijuana in the Past Month8.53 number of timesStandard Deviation 17.99
Attention-Placebo ControlAverage Number of Times Youth Smoked Marijuana in the Past Month8.54 number of timesStandard Deviation 17.97
Primary

Average Number of Times Youth Used Hard Drugs in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Used Hard Drugs in the Past Month0.58 number of timesStandard Deviation 3.92
Attention-Placebo ControlAverage Number of Times Youth Used Hard Drugs in the Past Month0.60 number of timesStandard Deviation 3.84
Primary

Average Number of Times Youth Used Hard Drugs in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Used Hard Drugs in the Past Month0.34 number of timesStandard Deviation 1.92
Attention-Placebo ControlAverage Number of Times Youth Used Hard Drugs in the Past Month0.62 number of timesStandard Deviation 3.65
Primary

Average Number of Times Youth Used Hard Drugs in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Used Hard Drugs in the Past Month0.65 number of timesStandard Deviation 3.63
Attention-Placebo ControlAverage Number of Times Youth Used Hard Drugs in the Past Month0.71 number of timesStandard Deviation 4.35
Primary

Average Number of Times Youth Used Hard Drugs in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Used Hard Drugs in the Past Month0.45 number of timesStandard Deviation 2.67
Attention-Placebo ControlAverage Number of Times Youth Used Hard Drugs in the Past Month0.61 number of timesStandard Deviation 4.34
Primary

Average Number of Times Youth Vaped Any Substance in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Vaped Any Substance in the Past Month3.09 number of timesStandard Deviation 11.69
Attention-Placebo ControlAverage Number of Times Youth Vaped Any Substance in the Past Month2.95 number of timesStandard Deviation 11.24
Primary

Average Number of Times Youth Vaped Any Substance in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Vaped Any Substance in the Past Month6.60 number of timesStandard Deviation 17.47
Attention-Placebo ControlAverage Number of Times Youth Vaped Any Substance in the Past Month5.80 number of timesStandard Deviation 16.13
Primary

Average Number of Times Youth Vaped Any Substance in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Vaped Any Substance in the Past Month9.23 number of timesStandard Deviation 20.68
Attention-Placebo ControlAverage Number of Times Youth Vaped Any Substance in the Past Month9.87 number of timesStandard Deviation 21.33
Primary

Average Number of Times Youth Vaped Any Substance in the Past Month

Participants will be asked to report the numbers of times they have used the substance in the past month.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionAverage Number of Times Youth Vaped Any Substance in the Past Month11.99 number of timesStandard Deviation 23.28
Attention-Placebo ControlAverage Number of Times Youth Vaped Any Substance in the Past Month11.11 number of timesStandard Deviation 22.32
Secondary

Mean Scores for Assertiveness

The assertiveness scale is a 3-item measure assessing how well youth believe they assert themselves. All items are averaged to yield a total score that ranges from 1 = low assertiveness to 5 = high assertiveness; higher scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Assertiveness2.83 score on a scaleStandard Deviation 1.12
Attention-Placebo ControlMean Scores for Assertiveness2.77 score on a scaleStandard Deviation 1.11
Secondary

Mean Scores for Assertiveness

The assertiveness scale is a 3-item measure assessing how well youth believe they assert themselves. All items are averaged to yield a total score that ranges from 1 = low assertiveness to 5 = high assertiveness; higher scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Assertiveness2.97 score on a scaleStandard Deviation 1.07
Attention-Placebo ControlMean Scores for Assertiveness2.93 score on a scaleStandard Deviation 1.1
Secondary

Mean Scores for Assertiveness

The assertiveness scale is a 3-item measure assessing how well youth believe they assert themselves. All items are averaged to yield a total score that ranges from 1 = low assertiveness to 5 = high assertiveness; higher scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Assertiveness2.92 score on a scaleStandard Deviation 1.08
Attention-Placebo ControlMean Scores for Assertiveness2.93 score on a scaleStandard Deviation 1.11
Secondary

Mean Scores for Assertiveness

The assertiveness scale is a 3-item measure assessing how well youth believe they assert themselves. All items are averaged to yield a total score that ranges from 1 = low assertiveness to 5 = high assertiveness; higher scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Assertiveness2.92 score on a scaleStandard Deviation 1.09
Attention-Placebo ControlMean Scores for Assertiveness2.80 score on a scaleStandard Deviation 1.11
Secondary

Mean Scores for Consequences of Substance Use

The consequences of substance use scale is a 13-item measure assessing how often youths' substance use has caused them trouble with the law, family, friends, and academics. All items are averaged to yield a total score that ranges from 0 = zero times to 10 = ten or more times; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Consequences of Substance Use0.15 score on a scaleStandard Deviation 0.4
Attention-Placebo ControlMean Scores for Consequences of Substance Use0.13 score on a scaleStandard Deviation 0.34
Secondary

Mean Scores for Consequences of Substance Use

The consequences of substance use scale is a 13-item measure assessing how often youths' substance use has caused them trouble with the law, family, friends, and academics. All items are averaged to yield a total score that ranges from 0 = zero times to 10 = ten or more times; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Consequences of Substance Use0.13 score on a scaleStandard Deviation 0.35
Attention-Placebo ControlMean Scores for Consequences of Substance Use0.14 score on a scaleStandard Deviation 0.4
Secondary

Mean Scores for Consequences of Substance Use

The consequences of substance use scale is a 13-item measure assessing how often youths' substance use has caused them trouble with the law, family, friends, and academics. All items are averaged to yield a total score that ranges from 0 = zero times to 10 = ten or more times; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Consequences of Substance Use0.12 score on a scaleStandard Deviation 0.33
Attention-Placebo ControlMean Scores for Consequences of Substance Use0.13 score on a scaleStandard Deviation 0.35
Secondary

Mean Scores for Consequences of Substance Use

The consequences of substance use scale is a 13-item measure assessing how often youths' substance use has caused them trouble with the law, family, friends, and academics. All items are averaged to yield a total score that ranges from 0 = zero times to 10 = ten or more times; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Consequences of Substance Use0.08 score on a scaleStandard Deviation 0.24
Attention-Placebo ControlMean Scores for Consequences of Substance Use0.13 score on a scaleStandard Deviation 0.41
Secondary

Mean Scores for Coping

The coping scale is a 6-item measure assessing the degree to which youth feel they can manage the difficulties in their life. All items are averaged to yield a total score that ranges from 0 = high coping skills to 3 = poor coping skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Coping2.75 score on a scaleStandard Deviation 0.45
Attention-Placebo ControlMean Scores for Coping2.70 score on a scaleStandard Deviation 0.47
Secondary

Mean Scores for Coping

The coping scale is a 6-item measure assessing the degree to which youth feel they can manage the difficulties in their life. All items are averaged to yield a total score that ranges from 0 = high coping skills to 3 = poor coping skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Coping2.87 score on a scaleStandard Deviation 0.48
Attention-Placebo ControlMean Scores for Coping2.78 score on a scaleStandard Deviation 0.47
Secondary

Mean Scores for Coping

The coping scale is a 6-item measure assessing the degree to which youth feel they can manage the difficulties in their life. All items are averaged to yield a total score that ranges from 0 = high coping skills to 3 = poor coping skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Coping2.79 score on a scaleStandard Deviation 0.48
Attention-Placebo ControlMean Scores for Coping2.74 score on a scaleStandard Deviation 0.47
Secondary

Mean Scores for Coping

The coping scale is a 6-item measure assessing the degree to which youth feel they can manage the difficulties in their life. All items are averaged to yield a total score that ranges from 0 = high coping skills to 3 = poor coping skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Coping2.77 score on a scaleStandard Deviation 0.45
Attention-Placebo ControlMean Scores for Coping2.67 score on a scaleStandard Deviation 0.45
Secondary

Mean Scores for Drug Refusal Skills

The drug refusal scale is a 15-item measure assessing the likelihood of youth using various refusal strategies when offered to use alcohol, cigarettes, or marijuana. All items are averaged to yield a total score that ranges from 1 = high refusal skills to 5 = poor refusal skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Drug Refusal Skills1.98 score on a scaleStandard Deviation 0.64
Attention-Placebo ControlMean Scores for Drug Refusal Skills2.05 score on a scaleStandard Deviation 0.63
Secondary

Mean Scores for Drug Refusal Skills

The drug refusal scale is a 15-item measure assessing the likelihood of youth using various refusal strategies when offered to use alcohol, cigarettes, or marijuana. All items are averaged to yield a total score that ranges from 1 = high refusal skills to 5 = poor refusal skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Drug Refusal Skills1.91 score on a scaleStandard Deviation 0.61
Attention-Placebo ControlMean Scores for Drug Refusal Skills2.04 score on a scaleStandard Deviation 0.65
Secondary

Mean Scores for Drug Refusal Skills

The drug refusal scale is a 15-item measure assessing the likelihood of youth using various refusal strategies when offered to use alcohol, cigarettes, or marijuana. All items are averaged to yield a total score that ranges from 1 = high refusal skills to 5 = poor refusal skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Drug Refusal Skills1.96 score on a scaleStandard Deviation 0.63
Attention-Placebo ControlMean Scores for Drug Refusal Skills2.01 score on a scaleStandard Deviation 0.62
Secondary

Mean Scores for Drug Refusal Skills

The drug refusal scale is a 15-item measure assessing the likelihood of youth using various refusal strategies when offered to use alcohol, cigarettes, or marijuana. All items are averaged to yield a total score that ranges from 1 = high refusal skills to 5 = poor refusal skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Drug Refusal Skills1.96 score on a scaleStandard Deviation 0.65
Attention-Placebo ControlMean Scores for Drug Refusal Skills2.01 score on a scaleStandard Deviation 0.61
Secondary

Mean Scores for Goal Setting

The goal setting scale is a 5-item measure assessing the degree to which youth set and work on goals. All items are averaged to yield a total score that ranges from 0 = low goal setting to 3 = higher goal setting; higher scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Goal Setting2.47 score on a scaleStandard Deviation 0.63
Attention-Placebo ControlMean Scores for Goal Setting2.39 score on a scaleStandard Deviation 0.63
Secondary

Mean Scores for Goal Setting

The goal setting scale is a 5-item measure assessing the degree to which youth set and work on goals. All items are averaged to yield a total score that ranges from 0 = low goal setting to 3 = higher goal setting; higher scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Goal Setting2.57 score on a scaleStandard Deviation 0.65
Attention-Placebo ControlMean Scores for Goal Setting2.49 score on a scaleStandard Deviation 0.62
Secondary

Mean Scores for Goal Setting

The goal setting scale is a 5-item measure assessing the degree to which youth set and work on goals. All items are averaged to yield a total score that ranges from 0 = low goal setting to 3 = higher goal setting; higher scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Goal Setting2.38 score on a scaleStandard Deviation 0.6
Attention-Placebo ControlMean Scores for Goal Setting2.34 score on a scaleStandard Deviation 0.62
Secondary

Mean Scores for Goal Setting

The goal setting scale is a 5-item measure assessing the degree to which youth set and work on goals. All items are averaged to yield a total score that ranges from 0 = low goal setting to 3 = higher goal setting; higher scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Goal Setting2.39 score on a scaleStandard Deviation 0.63
Attention-Placebo ControlMean Scores for Goal Setting2.36 score on a scaleStandard Deviation 0.61
Secondary

Mean Scores for Peer Drug Use

The peer drug use scale is a 7-item measuring that asks youth to indicate the number of close friends who have used various substances in the past month. All items are averaged to yield a total score that ranges from 0 = no peer use to 3 = all peers use; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Peer Drug Use0.41 score on a scaleStandard Deviation 0.47
Attention-Placebo ControlMean Scores for Peer Drug Use0.40 score on a scaleStandard Deviation 0.41
Secondary

Mean Scores for Peer Drug Use

The peer drug use scale is a 7-item measuring that asks youth to indicate the number of close friends who have used various substances in the past month. All items are averaged to yield a total score that ranges from 0 = no peer use to 3 = all peers use; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Peer Drug Use0.51 score on a scaleStandard Deviation 0.49
Attention-Placebo ControlMean Scores for Peer Drug Use0.54 score on a scaleStandard Deviation 0.48
Secondary

Mean Scores for Peer Drug Use

The peer drug use scale is a 7-item measuring that asks youth to indicate the number of close friends who have used various substances in the past month. All items are averaged to yield a total score that ranges from 0 = no peer use to 3 = all peers use; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Peer Drug Use0.64 score on a scaleStandard Deviation 0.51
Attention-Placebo ControlMean Scores for Peer Drug Use0.66 score on a scaleStandard Deviation 0.52
Secondary

Mean Scores for Peer Drug Use

The peer drug use scale is a 7-item measuring that asks youth to indicate the number of close friends who have used various substances in the past month. All items are averaged to yield a total score that ranges from 0 = no peer use to 3 = all peers use; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Peer Drug Use0.74 score on a scaleStandard Deviation 0.5
Attention-Placebo ControlMean Scores for Peer Drug Use0.77 score on a scaleStandard Deviation 0.53
Secondary

Mean Scores for Perceived Stress

The perceived stress scale is an 8-item measure assessing the degree to which youth feel overwhelmed by stress. All items are averaged to yield a total score that ranges from 0 = low perceived stress to 5 = high perceived stress; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Perceived Stress3.03 score on a scaleStandard Deviation 0.63
Attention-Placebo ControlMean Scores for Perceived Stress3.14 score on a scaleStandard Deviation 0.65
Secondary

Mean Scores for Perceived Stress

The perceived stress scale is an 8-item measure assessing the degree to which youth feel overwhelmed by stress. All items are averaged to yield a total score that ranges from 0 = low perceived stress to 5 = high perceived stress; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Perceived Stress3.19 score on a scaleStandard Deviation 0.65
Attention-Placebo ControlMean Scores for Perceived Stress3.30 score on a scaleStandard Deviation 0.64
Secondary

Mean Scores for Perceived Stress

The perceived stress scale is an 8-item measure assessing the degree to which youth feel overwhelmed by stress. All items are averaged to yield a total score that ranges from 0 = low perceived stress to 5 = high perceived stress; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Perceived Stress3.13 score on a scaleStandard Deviation 0.63
Attention-Placebo ControlMean Scores for Perceived Stress3.19 score on a scaleStandard Deviation 0.66
Secondary

Mean Scores for Perceived Stress

The perceived stress scale is an 8-item measure assessing the degree to which youth feel overwhelmed by stress. All items are averaged to yield a total score that ranges from 0 = low perceived stress to 5 = high perceived stress; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Perceived Stress3.21 score on a scaleStandard Deviation 0.66
Attention-Placebo ControlMean Scores for Perceived Stress3.39 score on a scaleStandard Deviation 0.62
Secondary

Mean Scores for Problem Solving

The problem solving scale is an 8-item measure assessing the degree to which youth employ skills to solve problems. All items are averaged to yield a total score that ranges from 1 = high problem solving to 4 = low problem solving; lower scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Problem Solving1.99 score on a scaleStandard Deviation 0.39
Attention-Placebo ControlMean Scores for Problem Solving2.03 score on a scaleStandard Deviation 0.39
Secondary

Mean Scores for Problem Solving

The problem solving scale is an 8-item measure assessing the degree to which youth employ skills to solve problems. All items are averaged to yield a total score that ranges from 1 = high problem solving to 4 = low problem solving; lower scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Problem Solving2.06 score on a scaleStandard Deviation 0.4
Attention-Placebo ControlMean Scores for Problem Solving2.12 score on a scaleStandard Deviation 0.43
Secondary

Mean Scores for Problem Solving

The problem solving scale is an 8-item measure assessing the degree to which youth employ skills to solve problems. All items are averaged to yield a total score that ranges from 1 = high problem solving to 4 = low problem solving; lower scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Problem Solving2.06 score on a scaleStandard Deviation 0.42
Attention-Placebo ControlMean Scores for Problem Solving2.10 score on a scaleStandard Deviation 0.42
Secondary

Mean Scores for Problem Solving

The problem solving scale is an 8-item measure assessing the degree to which youth employ skills to solve problems. All items are averaged to yield a total score that ranges from 1 = high problem solving to 4 = low problem solving; lower scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Problem Solving2.03 score on a scaleStandard Deviation 0.4
Attention-Placebo ControlMean Scores for Problem Solving2.08 score on a scaleStandard Deviation 0.43
Secondary

Mean Scores for Self-Efficacy

The self-efficacy scale is a 7-item measuring youths' perceived ability to handle difficult life situations. All items are averaged to yield a total score that ranges from 0 = high self-efficacy to 4 = low self-efficacy; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Self-Efficacy2.13 score on a scaleStandard Deviation 0.49
Attention-Placebo ControlMean Scores for Self-Efficacy2.19 score on a scaleStandard Deviation 0.5
Secondary

Mean Scores for Self-Efficacy

The self-efficacy scale is a 7-item measuring youths' perceived ability to handle difficult life situations. All items are averaged to yield a total score that ranges from 0 = high self-efficacy to 4 = low self-efficacy; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Self-Efficacy2.25 score on a scaleStandard Deviation 0.48
Attention-Placebo ControlMean Scores for Self-Efficacy2.36 score on a scaleStandard Deviation 0.52
Secondary

Mean Scores for Self-Efficacy

The self-efficacy scale is a 7-item measuring youths' perceived ability to handle difficult life situations. All items are averaged to yield a total score that ranges from 0 = high self-efficacy to 4 = low self-efficacy; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Self-Efficacy2.22 score on a scaleStandard Deviation 0.47
Attention-Placebo ControlMean Scores for Self-Efficacy2.26 score on a scaleStandard Deviation 0.52
Secondary

Mean Scores for Self-Efficacy

The self-efficacy scale is a 7-item measuring youths' perceived ability to handle difficult life situations. All items are averaged to yield a total score that ranges from 0 = high self-efficacy to 4 = low self-efficacy; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Self-Efficacy2.27 score on a scaleStandard Deviation 0.51
Attention-Placebo ControlMean Scores for Self-Efficacy2.38 score on a scaleStandard Deviation 0.51
Secondary

Mean Scores for Self-Esteem

The self-esteem scale is a 10-item measure assessing youths' feelings of self-worth and value. All items are averaged to yield a total score that ranges from 1 = higher self-esteem to 4 = lower self-esteem; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 3-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 3-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Self-Esteem2.37 score on a scaleStandard Deviation 0.57
Attention-Placebo ControlMean Scores for Self-Esteem2.42 score on a scaleStandard Deviation 0.61
Secondary

Mean Scores for Self-Esteem

The self-esteem scale is a 10-item measure assessing youths' feelings of self-worth and value. All items are averaged to yield a total score that ranges from 1 = higher self-esteem to 4 = lower self-esteem; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: an average of 5 months from study onset

Population: The analyzed population reflects only those participants who completed the assessment at approx. 5 months after baseline.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Self-Esteem2.63 score on a scaleStandard Deviation 0.57
Attention-Placebo ControlMean Scores for Self-Esteem2.73 score on a scaleStandard Deviation 0.56
Secondary

Mean Scores for Self-Esteem

The self-esteem scale is a 10-item measure assessing youths' feelings of self-worth and value. All items are averaged to yield a total score that ranges from 1 = higher self-esteem to 4 = lower self-esteem; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 2-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 2-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Self-Esteem2.49 score on a scaleStandard Deviation 0.54
Attention-Placebo ControlMean Scores for Self-Esteem2.52 score on a scaleStandard Deviation 0.58
Secondary

Mean Scores for Self-Esteem

The self-esteem scale is a 10-item measure assessing youths' feelings of self-worth and value. All items are averaged to yield a total score that ranges from 1 = higher self-esteem to 4 = lower self-esteem; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.

Time frame: 1-year follow-up

Population: The analyzed population reflects only those participants who completed the assessment at 1-year follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Scores for Self-Esteem2.56 score on a scaleStandard Deviation 0.57
Attention-Placebo ControlMean Scores for Self-Esteem2.63 score on a scaleStandard Deviation 0.57

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026