Adolescent Alcohol UsePhase 4SAAF-STEPSNCT03590132
Strong African American Families STEPS Project
A Phase 4 study testing Strong African American Families Program and Strong African American Families--Teen Program in people with Adolescent Alcohol Use, run by University of Georgia.
Trial summary
The most common approach to preventing alcohol use involves providing a well-designed program in preadolescence just prior to or upon entering middle school. This approach does not have long-lasting effects or address the risk factors that lead many youth to use alcohol in high school. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Alcohol Use
- What is being tested?
- Strong African American Families Program and Strong African American Families--Teen Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2012to 30 Nov 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- self reported African American
- 5th grade
Who cannot join
- unable to attend a family-centered prevention intervention due to incapacitation of youth
- unable to attend a family-centered prevention intervention due to incapacitation of youth
About this study
Official title: A Dual Inoculation Approach to Alcohol Prevention Among African American Youth
The most common approach to preventing alcohol use involves providing a well-designed program in preadolescence just prior to or upon entering middle school. This approach does not have long-lasting effects or address the risk factors that lead many youth to use alcohol in high school. This study tested a strategy that compares offering effective programs at the transition to middle school and the transition to high school with only offering a program at either one of the transitions or no programs at all.
Read the detailed description
Alcohol use is a leading cause of morbidity and mortality among high school students. Annually, underage drinking leads to more than 3,000 deaths and 2.6 million other harmful events, resulting in $5.4 billion in medical costs, $14.9 billion in work loss and other resource costs, and $41.6 billion in lost quality of life. This public health crisis has engendered considerable attention from prevention scientists, who have specified guidelines for the development of primary prevention programs and the timing of their implementation. The present research is based on critical limitations in the prevailing model for implementing primary prevention for alcohol use. This model focuses on delaying alcohol use onset among youth who begin use in middle school (ages 11-14). Based on studies that linked early use to a high-risk behavioral trajectory in adolescence, prevention scientists translated data on risk and protective processes for early-onset alcohol use into primary prevention programs for youth to be implemented during or just prior to the transition to adolescence. This model has informed numerous randomized prevention trials and investigations of prevention implementation. An unquestioned premise of this model involves the adequacy of a single preadolescent "inoculation" of prevention programming to protect youth into the high school years.
The proposed trial addresses empirical and theoretical limitations to the preadolescent/single inoculation paradigm. First, inclusive reviews reveal that primary prevention programs implemented in early adolescence fail to achieve robust, long-term results. Second, studies of alcohol use trajectories reveal patterns of onset in high school with rapid escalation that culminate in high levels of alcohol use. Third, in the prevailing paradigm, targeting early adolescent risk processes is assumed to be sufficient to equip youth for the novel risk processes they will encounter in high school. In contrast, this study investigates the proposition that achievement of public health impact requires a "dual-inoculation" prevention strategy, one that addresses both onset in early adolescence and mid-adolescence and provides developmentally tailored curricula at each transition.
Based on longitudinal studies with rural African American families that documented the changing context of alcohol use risk and protective processes from late childhood through adolescence, scientists at the Center for Family Research developed a series of developmentally appropriate, family-centered preventive interventions that have proven efficacious in in preventing alcohol use: the Strong African American Families (SAAF) program for youth age 10-12 and the SAAF-Teen program for youth age 14-16. These programs afford a unique opportunity to test dual-inoculation hypotheses. Unlike medical inoculations of a vaccine, it is not appropriate to give the same inoculation to an 11-year-old that one gives a 14-year-old. Rather, each preventive inoculation must be tailored to address the most salient risk and protective processes at particular developmental transitions.
This study will recruit a sample of 460 African American families into a four-arm randomized prevention trial and evaluate the differential alcohol prevention effects of (a) a dual inoculation of prevention (youth receive SAAF at age 11 and SAAF-Teen at age 14) compared with (b) receipt of a preadolescent inoculation (SAAF at age 11), (c) receipt of a mid-adolescent inoculation (SAAF-Teen at age 14), or (d) a minimal contact control.
Specific efficacy aims are to:
- Test the hypothesis that rural African American youth randomly assigned to participate in two prevention inoculations will demonstrate lower rates of alcohol use initiation, frequency of use, binge drinking, and alcohol-related problems in high school than will youth who receive a preadolescent inoculation only, a mid-adolescent inoculation only, or no inoculations.
- Investigate the intervening processes that account for the relative efficacy of a dual inoculation. Specifically, we expect that intervention-targeted early adolescent protective processes, early adolescent alcohol use outcomes, and intervention-targeted mid-adolescent protective processes will account for group differences in alcohol use in high school. To facilitate the potential dissemination of a dual inoculation approach, this study investigates the cost-effectiveness of a dual inoculation relative to preadolescent, mid-adolescent, or control conditions. The specific cost-effectiveness aim is to:
- Conduct a cost-effectiveness analyses that estimates the incremental cost of a dual inoculation compared to single inoculations and no inoculations per additional unit decrease in alcohol use initiation, escalation, binge drinking, and alcohol-related problems. This study will investigate an ancillary hypothesis involving the incremental cost difference per outcome unit between preadolescent and mid-adolescent inoculations relative to the control condition.
- Conditions
- Adolescent Alcohol Use
- Being tested
- Strong African American Families Program, Strong African American Families--Teen Program
- Keywords
- adolescent, alcohol, family-centered prevention, African American
- Medical subject headings
- Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strong African American Families ProgramBehavioural
Also called SAAF
SAAF is a 7 session family skills training program
Strong African American Families--Teen ProgramBehavioural
Also called SAAF--T
SAAF-T is a 5 session family skills training program
| Study group | Role | What they receive |
|---|---|---|
| SAAF | Experimental | participants in this arm receive the SAAF intervention at age 11-12. Receives: Behavioral: Strong African American Families Program |
| SAAF-T | Experimental | participants in this arm receive the SAAF-Teen intervention at age 14-15. Receives: Behavioral: Strong African American Families--Teen Program |
| SAAF SAAF-T | Experimental | participants in this arm receive SAAF at age 11-12 and later receive SAAF-Teen at age 14-15 Receives: Behavioral: Strong African American Families Program; Behavioral: Strong African American Families--Teen Program |
| Control | No intervention | These participants receive no interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use in past 3 months (single item)
Youth complete this single item from Monitoring the Future Study assessing the frequency of alcohol use in the past 3 months. There is an ordinal response scale ranging from 0 (none) to 6 (30 or more times). Higher response numbers indicate a worse outcome (more alcohol use).
Measured: 3 months
Frequency of cannabis use in the past 3 months (single item)
Single item from Monitoring the Future Study assessing frequency of marijuana use in the past 3 months. There is an ordinal response scale ranging from 0 (none) to 6 (30 or more times). Higher responses indicate a worse outcome (more marijuana use in the past 3 months).
Measured: 3 months
Monitoring the Future: Total substance use (summative index of use of alcohol, cannabis, and nicotine)
Youth complete 3 single items from the Monitoring the Future study indexing the frequency of their use of alcohol, cannabis, and nicotine in past 3 months. There is an ordinal response scale ranging from 0 (none) to 6 (30 or more times) for each item. The three items are summed yielding a scale ranging from 0-18. Higher response numbers indicate a worse outcome (more substance use).
Measured: 3 months
Secondary outcomes (3)
Center for Epidemiological studies-Depression scale
Parent complete this 20 item measure of depressive symptoms. Responses to each item are on a scale from 0 to 3; responses are summed. Items are summed. Scores range from 0-60 with higher scores indicate more depressive symptoms in the past week (a worse outcome).
Measured: Past 7 days
The National Survey of Adolescents Conduct Problems Subscale
Youth complete a 15 Item scale from the National Survey of Adolescents which refer to different conduct problems. Youth provide the number of times they enacted each behavior in the past 3 months. These responses are summed. Scores can range from 0-99 with higher scores indicating more engagement in conduct problems.
Measured: past 3 months
Center for Epidemiological Studies-Depression Scale-Child Version
Youth complete this 20 item measure of depressive symptoms. Responses to each item are on a likert scale from 0 to 3; responses are summed. Scores range from 0-60 with higher scores indicate more depressive symptoms in the past week (a worse outcome).
Measured: past 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start10 Dec 2012
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adolescent Alcohol UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A 4 arm trial, participants receive either a preadolescent intervention only, a mid-adolescent intervention only, both preadolescent and mid-adolescent intervention, or no intervention
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Kogan, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590132
- Sponsor's protocol ID
- UGA045608
- Acronym
- SAAF-STEPS
- Status last verified
- Jun 2019
- First submitted
- 12 Jun 2018
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants have not consented to data being shared outside of research team
Publications
Kogan SM, Reck AJ, Tiwari B, Thapha JR, Carter S, Oshri A, Koss K, Ahn SJ, Beach S, Fisher S, Smith E, Zhang L. Family-Centered Prevention Attenuates the Association Between Structural Racism Risk and Black Adolescents' Low Self-regulation and Externalizing Behaviors: Secondary Analysis of a Randomized Clinical Trial. Prev Sci. 2025 Aug;26(6):932-942. doi: 10.1007/s11121-025-01828-5. Epub 2025 Jul 17.
PubMed 40676489Kogan SM, Kwon E, Brody GH, Azarmehr R, Reck AJ, Anderson T, Sperr M. Family-Centered Prevention to Reduce Discrimination-Related Depressive Symptoms Among Black Adolescents: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2340567. doi: 10.1001/jamanetworkopen.2023.40567.
PubMed 37910105
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dual Inoculation Approach to Alcohol Prevention Among African American Youth
- ClinicalTrials.gov ID
- NCT03590132
- Acronym / sponsor ID
- SAAF-STEPS / UGA045608
- Conditions
- Adolescent Alcohol Use
- Keywords
- adolescent, alcohol, family-centered prevention, African American
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- 10 Dec 2012 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The most common approach to preventing alcohol use involves providing a well-designed program in preadolescence just prior to or upon entering middle school. This approach does not have long-lasting effects or address the risk factors that lead many youth to use alcohol in high school. This study tested a strategy that compares offering effective programs at the transition to middle school and the transition to high school with only offering a program at either one of the transitions or no programs at all.
Detailed description
Alcohol use is a leading cause of morbidity and mortality among high school students. Annually, underage drinking leads to more than 3,000 deaths and 2.6 million other harmful events, resulting in $5.4 billion in medical costs, $14.9 billion in work loss and other resource costs, and $41.6 billion in lost quality of life. This public health crisis has engendered considerable attention from prevention scientists, who have specified guidelines for the development of primary prevention programs and the timing of their implementation. The present research is based on critical limitations in the prevailing model for implementing primary prevention for alcohol use. This model focuses on delaying alcohol use onset among youth who begin use in middle school (ages 11-14). Based on studies that linked early use to a high-risk behavioral trajectory in adolescence, prevention scientists translated data on risk and protective processes for early-onset alcohol use into primary prevention programs for youth to be implemented during or just prior to the transition to adolescence. This model has informed numerous randomized prevention trials and investigations of prevention implementation. An unquestioned premise of this model involves the adequacy of a single preadolescent "inoculation" of prevention programming to protect youth into the high school years.
The proposed trial addresses empirical and theoretical limitations to the preadolescent/single inoculation paradigm. First, inclusive reviews reveal that primary prevention programs implemented in early adolescence fail to achieve robust, long-term results. Second, studies of alcohol use trajectories reveal patterns of onset in high school with rapid escalation that culminate in high levels of alcohol use. Third, in the prevailing paradigm, targeting early adolescent risk processes is assumed to be sufficient to equip youth for the novel risk processes they will encounter in high school. In contrast, this study investigates the proposition that achievement of public health impact requires a "dual-inoculation" prevention strategy, one that addresses both onset in early adolescence and mid-adolescence and provides developmentally tailored curricula at each transition.
Based on longitudinal studies with rural African American families that documented the changing context of alcohol use risk and protective processes from late childhood through adolescence, scientists at the Center for Family Research developed a series of developmentally appropriate, family-centered preventive interventions that have proven efficacious in in preventing alcohol use: the Strong African American Families (SAAF) program for youth age 10-12 and the SAAF-Teen program for youth age 14-16. These programs afford a unique opportunity to test dual-inoculation hypotheses. Unlike medical inoculations of a vaccine, it is not appropriate to give the same inoculation to an 11-year-old that one gives a 14-year-old. Rather, each preventive inoculation must be tailored to address the most salient risk and protective processes at particular developmental transitions.
This study will recruit a sample of 460 African American families into a four-arm randomized prevention trial and evaluate the differential alcohol prevention effects of (a) a dual inoculation of prevention (youth receive SAAF at age 11 and SAAF-Teen at age 14) compared with (b) receipt of a preadolescent inoculation (SAAF at age 11), (c) receipt of a mid-adolescent inoculation (SAAF-Teen at age 14), or (d) a minimal contact control.
Specific efficacy aims are to:
- Test the hypothesis that rural African American youth randomly assigned to participate in two prevention inoculations will demonstrate lower rates of alcohol use initiation, frequency of use, binge drinking, and alcohol-related problems in high school than will youth who receive a preadolescent inoculation only, a mid-adolescent inoculation only, or no inoculations.
- Investigate the intervening processes that account for the relative efficacy of a dual inoculation. Specifically, we expect that intervention-targeted early adolescent protective processes, early adolescent alcohol use outcomes, and intervention-targeted mid-adolescent protective processes will account for group differences in alcohol use in high school. To facilitate the potential dissemination of a dual inoculation approach, this study investigates the cost-effectiveness of a dual inoculation relative to preadolescent, mid-adolescent, or control conditions. The specific cost-effectiveness aim is to:
- Conduct a cost-effectiveness analyses that estimates the incremental cost of a dual inoculation compared to single inoculations and no inoculations per additional unit decrease in alcohol use initiation, escalation, binge drinking, and alcohol-related problems. This study will investigate an ancillary hypothesis involving the incremental cost difference per outcome unit between preadolescent and mid-adolescent inoculations relative to the control condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- A 4 arm trial, participants receive either a preadolescent intervention only, a mid-adolescent intervention only, both preadolescent and mid-adolescent intervention, or no intervention
| Arm | Type | Receives |
|---|---|---|
| SAAF | Experimental | Behavioral: Strong African American Families Programparticipants in this arm receive the SAAF intervention at age 11-12. |
| SAAF-T | Experimental | Behavioral: Strong African American Families--Teen Programparticipants in this arm receive the SAAF-Teen intervention at age 14-15. |
| SAAF SAAF-T | Experimental | Behavioral: Strong African American Families Program, Behavioral: Strong African American Families--Teen Programparticipants in this arm receive SAAF at age 11-12 and later receive SAAF-Teen at age 14-15 |
| Control | No intervention | –These participants receive no interventions. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- self reported African American
- 5th grade
Key exclusion criteria (2 listed)
- unable to attend a family-centered prevention intervention due to incapacitation of youth
- unable to attend a family-centered prevention intervention due to incapacitation of youth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strong African American Families ProgramAlso: SAAFSAAF is a 7 session family skills training program | Behavioural | SAAF, SAAF SAAF-T |
| Strong African American Families--Teen ProgramAlso: SAAF--TSAAF-T is a 5 session family skills training program | Behavioural | SAAF SAAF-T, SAAF-T |
Primary outcome
Alcohol use in past 3 months (single item)
Time frame: 3 months
Youth complete this single item from Monitoring the Future Study assessing the frequency of alcohol use in the past 3 months. There is an ordinal response scale ranging from 0 (none) to 6 (30 or more times). Higher response numbers indicate a worse outcome (more alcohol use).
Frequency of cannabis use in the past 3 months (single item)
Time frame: 3 months
Single item from Monitoring the Future Study assessing frequency of marijuana use in the past 3 months. There is an ordinal response scale ranging from 0 (none) to 6 (30 or more times). Higher responses indicate a worse outcome (more marijuana use in the past 3 months).
Monitoring the Future: Total substance use (summative index of use of alcohol, cannabis, and nicotine)
Time frame: 3 months
Youth complete 3 single items from the Monitoring the Future study indexing the frequency of their use of alcohol, cannabis, and nicotine in past 3 months. There is an ordinal response scale ranging from 0 (none) to 6 (30 or more times) for each item. The three items are summed yielding a scale ranging from 0-18. Higher response numbers indicate a worse outcome (more substance use).
3 secondary outcomes
Center for Epidemiological studies-Depression scale
Time frame: Past 7 days
The National Survey of Adolescents Conduct Problems Subscale
Time frame: past 3 months
Center for Epidemiological Studies-Depression Scale-Child Version
Time frame: past 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Derived from this study: PubMed 40676489Kogan SM, Reck AJ, Tiwari B, Thapha JR, Carter S, Oshri A, Koss K, Ahn SJ, Beach S, Fisher S, Smith E, Zhang L. Family-Centered Prevention Attenuates the Association Between Structural Racism Risk and Black Adolescents' Low Self-regulation and Externalizing Behaviors: Secondary Analysis of a Randomized Clinical Trial. Prev Sci. 2025 Aug;26(6):932-942. doi: 10.1007/s11121-025-01828-5. Epub 2025 Jul 17.
- Derived from this study: PubMed 37910105Kogan SM, Kwon E, Brody GH, Azarmehr R, Reck AJ, Anderson T, Sperr M. Family-Centered Prevention to Reduce Discrimination-Related Depressive Symptoms Among Black Adolescents: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2340567. doi: 10.1001/jamanetworkopen.2023.40567.
- Individual participant dataSharing planned: No. Participants have not consented to data being shared outside of research team
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Strong African American Families Program and Strong African American Families--Teen Program in people with Adolescent Alcohol Use, run by University of Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol use in past 3 months (single item) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03590132, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.