Risk BehaviorNCT00099385
Comprehensive Elementary School Risk Prevention
A study testing Social Development Instruction in people with Risk Behavior, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
This project will evaluate the benefit of an enhanced social development program in grades 3-6 to decrease the onset of risky behaviors in pre-adolescents. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Behavior
- What is being tested?
- Social Development Instruction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,620 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jul 2010
- 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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All regular education students, including students in bilingual classes
Who cannot join
- Children attending special education classrooms.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520-8064
About this study
This project will evaluate the benefit of an enhanced social development program in grades 3-6 to decrease the onset of risky behaviors in pre-adolescents.
Read the detailed description
Educational programs to promote the adoption of healthy behaviors and to decrease the onset of risky behaviors in pre-adolescents are far more likely to be successful than attempts to alter established patterns of high-risk behaviors. The project involves an evaluation of a comprehensive 4-year elementary school prevention initiative starting in 3rd grade. The prevention initiative, grounded in social cognitive, influence, and development theories is embedded within a pre-existing comprehensive elementary school social development program and will employ an evidence-based social skills curriculum (PATHS) in selected schools. The aim of the program is to teach children to use problem-solving and communication skills to negotiate and prevent high-risk behaviors.
Students attending schools that will receive the enhanced social development program will be compared to students attending schools that will receive the current, standard social development curriculum. The study hypothesizes that students who participate in the 4-year enhanced social development program will self-report fewer risk behaviors when surveyed by the school system in grades 6-8.
- Conditions
- Risk Behavior
- Being tested
- Social Development Instruction
- Keywords
- social development, risk behaviors, social emotional education, classroom instruction
- Medical subject headings
- Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Development InstructionBehavioural
Weekly instruction during regular classroom time by classroom teacher using PATHS (Greenberg \& Kusche) curriculum.
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reports of risky behaviors
Measured: Spring of 2008,2009,2010
Secondary outcomes (2)
Academic test scores
Measured: annually 2006-2008
Measure of social problem solving skills: Social Problem Solving Dilemma
Measured: Spring 2007,2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2004 (estimated)
- Study startSep 2004
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk 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
- 2,620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, David Schonfeld, Children's Hospital Medical Center, Cincinnati
- Investigators
- David J Schonfeld, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099385
- Sponsor's protocol ID
- R01HD045362
- Status last verified
- Feb 2012
- First submitted
- 13 Dec 2004
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Elementary School Risk Prevention
- ClinicalTrials.gov ID
- NCT00099385
- Acronym / sponsor ID
- R01HD045362
- Conditions
- Risk Behavior
- Keywords
- social development, risk behaviors, social emotional education, classroom instruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,620 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Sep 2004
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Dec 2004 (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.
This project will evaluate the benefit of an enhanced social development program in grades 3-6 to decrease the onset of risky behaviors in pre-adolescents.
Detailed description
Educational programs to promote the adoption of healthy behaviors and to decrease the onset of risky behaviors in pre-adolescents are far more likely to be successful than attempts to alter established patterns of high-risk behaviors. The project involves an evaluation of a comprehensive 4-year elementary school prevention initiative starting in 3rd grade. The prevention initiative, grounded in social cognitive, influence, and development theories is embedded within a pre-existing comprehensive elementary school social development program and will employ an evidence-based social skills curriculum (PATHS) in selected schools. The aim of the program is to teach children to use problem-solving and communication skills to negotiate and prevent high-risk behaviors.
Students attending schools that will receive the enhanced social development program will be compared to students attending schools that will receive the current, standard social development curriculum. The study hypothesizes that students who participate in the 4-year enhanced social development program will self-report fewer risk behaviors when surveyed by the school system in grades 6-8.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All regular education students, including students in bilingual classes
Key exclusion criteria (1 listed)
- Children attending special education classrooms.
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 |
|---|---|---|
| Social Development InstructionWeekly instruction during regular classroom time by classroom teacher using PATHS (Greenberg \& Kusche) curriculum. | Behavioural | – |
Primary outcome
Self reports of risky behaviors
Time frame: Spring of 2008,2009,2010
2 secondary outcomes
Academic test scores
Time frame: annually 2006-2008
Measure of social problem solving skills: Social Problem Solving Dilemma
Time frame: Spring 2007,2008
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 17 Feb 2012.
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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.
David J Schonfeld, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Development Instruction in people with Risk Behavior, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 1 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 17 Feb 2012. 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?
Self reports of risky behaviors (time frame: Spring of 2008,2009,2010). 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 17 Feb 2012.