Risky Sexual BehaviorNCT00535704
Preventing Substance Use and Risky Behavior Among Rural African American Youth
A study testing Strong African American Families-Teen Program and FUEL in people with Risky Sexual Behavior, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The Rural African American Families Health (RAAFH) Project is a federally funded research study designed to evaluate the effectiveness two prevention programs designed for rural African American families. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Risky Sexual Behavior
- What is being tested?
- Strong African American Families-Teen Program and FUEL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2012
- Phase
- Interventional
- 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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- African American student in 10th grade
- Agree to randomization and assessment
- Resides in targeted county
- Target and parent speak English
Who cannot join
- Active psychoses
Trial locations and contacts
1 site in 1 country.
About this study
The Rural African American Families Health (RAAFH) Project is a federally funded research study designed to evaluate the effectiveness two prevention programs designed for rural African American families. One program, FUEL, helps teens develop lifestyles that prevent health problems such as heart disease, diabetes, and being overweight. This program deals with diet and exercise, the influence of TV and magazines on eating habits, and handling stress. The second program, the Strong African American Families Teen Program (SAAF-T), helps teens learn how to develop plans for the future and to avoid drug use and unsafe sex. The sessions deal with goal setting, peer pressure, and staying in school.
- Conditions
- Risky Sexual Behavior
- Being tested
- Strong African American Families-Teen Program, FUEL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strong African American Families-Teen ProgramBehavioural
5 week educational program for teens and their caregivers.Each meeting lasts approximately 2 hours.
FUELBehavioural
5 week educational program for teens and caregivers. Each weekly session lasts approximately 2 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The Strong AFrican American FAmilies-Teen program is a five part educational program has been designed to help teens and their parents create successful futures and avoid the risky behaviors that sometimes keep teens from reaching their goals. Receives: Behavioral: Strong African American Families-Teen Program |
| 2 | Other | The FUEL program is a family-based adaptation of a curriculum designed to assist teens to develop lifestyles that prevent health problems such as heart disease, diabetes, and being overweight. This program deals with diet and exercise, the influence of TV and magazines on eating habits, and handling stress. Receives: Behavioral: FUEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual behavior
Measured: 3 months
Secondary outcomes (1)
Substance Use
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risky Sexual BehaviorStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gene H Brody, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535704
- Sponsor's protocol ID
- 1R01DA021736-01
- Status last verified
- Apr 2014
- First submitted
- 24 Sep 2007
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Substance Use and Risky Behavior Among Rural African American Youth
- ClinicalTrials.gov ID
- NCT00535704
- Acronym / sponsor ID
- 1R01DA021736-01
- Conditions
- Risky Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Nov 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Sep 2007 (estimated)
- 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 Rural African American Families Health (RAAFH) Project is a federally funded research study designed to evaluate the effectiveness two prevention programs designed for rural African American families. One program, FUEL, helps teens develop lifestyles that prevent health problems such as heart disease, diabetes, and being overweight. This program deals with diet and exercise, the influence of TV and magazines on eating habits, and handling stress. The second program, the Strong African American Families Teen Program (SAAF-T), helps teens learn how to develop plans for the future and to avoid drug use and unsafe sex. The sessions deal with goal setting, peer pressure, and staying in school.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Strong African American Families-Teen ProgramThe Strong AFrican American FAmilies-Teen program is a five part educational program has been designed to help teens and their parents create successful futures and avoid the risky behaviors that sometimes keep teens from reaching their goals. |
| 2 | Other | Behavioral: FUELThe FUEL program is a family-based adaptation of a curriculum designed to assist teens to develop lifestyles that prevent health problems such as heart disease, diabetes, and being overweight. This program deals with diet and exercise, the influence of TV and magazines on eating habits, and handling stress. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- African American student in 10th grade
- Agree to randomization and assessment
- Resides in targeted county
- Target and parent speak English
Key exclusion criteria (1 listed)
- Active psychoses
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-Teen Program5 week educational program for teens and their caregivers.Each meeting lasts approximately 2 hours. | Behavioural | 1 |
| FUEL5 week educational program for teens and caregivers. Each weekly session lasts approximately 2 hours | Behavioural | 2 |
Primary outcome
Sexual behavior
Time frame: 3 months
1 secondary outcome
Substance Use
Time frame: 3 months
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 11 Jan 2017.
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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.
Gene H Brody principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strong African American Families-Teen Program and FUEL in people with Risky Sexual Behavior, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
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 4 inclusion and 1 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 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Sexual behavior (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2017.