Substance Use DisordersNCT00062959
Preventing Problem Behavior Among Middle School Students
A study testing Going Places: School program to prevent problem behavior in people with Substance Use Disorders and Health Promotion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Trial summary
Problem behaviors such as drug use, violence, and school misconduct increase during adolescence. This study evaluated a program designed to prevent problem behaviors in middle school students; the program includes classroom instruction for students and home instruction for parents. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders, Health Promotion
- What is being tested?
- Going Places: School program to prevent problem behavior
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,768 participants
- Where
- No sites listed yet
- Study dates
- Jun 1994to Jun 2000
- 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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attends participating middle schools
- Reads at grade level
Who cannot join
None listed.
About this study
Official title: Preventing Problem Behaviors Among Middle School Students
Problem behaviors such as drug use, violence, and school misconduct increase during adolescence. This study evaluated a program designed to prevent problem behaviors in middle school students; the program includes classroom instruction for students and home instruction for parents.
Read the detailed description
The prevalence of problem behaviors, such as school misconduct, underachievement, and dropout; tobacco, alcohol, and other drug use; and violence and delinquency, increases dramatically during adolescence. These behaviors place youths at an increased risk for school failure, involvement in the criminal justice system, and chronic substance abuse.
The purpose of this study was to test the efficacy of a comprehensive program of interventions, called Going Places, that includes participatory classroom curriculum, parent education, and enhanced school environment. The primary goal of these components was to help students learn social competence skills that will help them make positive decisions in their lives. The classroom curriculum component was integrated into the participating schools' regular Language Arts curriculum in grades 6 through 8. The curriculum provided instruction in and opportunities to practice interpersonal communication, self-management, problem solving, and conflict management. Brief videotapes with student actors served as trigger films to stimulate student interest, provide models, and motivate prosocial behavior. Parents in the participating schools received instruction via videotape and print materials and participated in student homework exercises. The emphasis was on encouraging parents to remain involved, adopt creative monitoring practices, and foster adolescent autonomy by establishing rules and conditions leading incrementally to greater independence.
Students in the seven Charles County, Maryland, middle schools were randomized either to the Going Places intervention group or to the usual education control group. The intervention was sequentially structured, with curricula implemented in each grade of middle school. Questionnaires were administered to all middle school students at the beginning of the 6th grade (before the intervention) to establish baseline levels of substance use, school misconduct, parent and peer influences, and school climate. Students completed surveys in the spring of grades 6, 7, and 8. A final follow-up survey was completed in the fall of ninth grade. The surveys assessed standard measures of tobacco, alcohol, and illicit drug use, school misconduct, and participation in school activities. The surveys also included items related to psychosocial, parental, and school factors.
- Conditions
- Substance Use Disorders, Health Promotion
- Being tested
- Going Places: School program to prevent problem behavior
- Keywords
- Adolescence, Parenting, School, Primary Prevention, School-based intervention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Going Places: School program to prevent problem behaviorBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2003 (estimated)
- Study startJun 1994
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies 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
- Factorial
- Masking
- Single blind
- Enrolment
- 2,768 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Bruce Simons-Morton, EdD, MPH, Principal investigator, Prevention Research Branch, Division of Epidemiology, Statistics and Prevention Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062959
- Sponsor's protocol ID
- N01HD33207
- Other IDs
- Z01 HD 02110-07-PR, NO1-HD-3-3207, NICHD-400, Z01HD002110-07
- Status last verified
- May 2003
- First submitted
- 18 Jun 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Simons-Morton BG, Crump AD. Association of parental involvement and social competence with school adjustment and engagement among sixth graders. J Sch Health. 2003 Mar;73(3):121-6. doi: 10.1111/j.1746-1561.2003.tb03586.x.
PubMed 12683346Simons-Morton BG. Prospective analysis of peer and parent influences on smoking initiation among early adolescents. Prev Sci. 2002 Dec;3(4):275-83. doi: 10.1023/a:1020876625045.
PubMed 12465590Simons-Morton B, Haynie DL, Crump AD, Eitel SP, Saylor KE. Peer and parent influences on smoking and drinking among early adolescents. Health Educ Behav. 2001 Feb;28(1):95-107. doi: 10.1177/109019810102800109.
PubMed 11213145Simons-Morton BG, Crump AD, Haynie DL, Saylor KE. Student-school bonding and adolescent problem behavior. Health Educ Res. 1999 Feb;14(1):99-107. doi: 10.1093/her/14.1.99.
PubMed 10537951Simons-Morton B, Crump AD, Haynie DL, Saylor KE, Eitel P, Yu K. Psychosocial, school, and parent factors associated with recent smoking among early-adolescent boys and girls. Prev Med. 1999 Feb;28(2):138-48. doi: 10.1006/pmed.1998.0404.
PubMed 10048105Simons-Morton B, Haynie DL, Crump AD, Saylor KE, Eitel P, Yu K. Expectancies and other psychosocial factors associated with alcohol use among early adolescent boys and girls. Addict Behav. 1999 Mar-Apr;24(2):229-38. doi: 10.1016/s0306-4603(98)00095-1.
PubMed 10336104Haynie DL, Nansel T, Eitel P, Crump AD, Saylor K, Yu K, Simons-Morton, B. Bullies, victims, and bully-victims: Distinct groups of youth at risk. Journal of Early Adolescence 21(1):95-107, 2001.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Problem Behaviors Among Middle School Students
- ClinicalTrials.gov ID
- NCT00062959
- Acronym / sponsor ID
- N01HD33207
- Conditions
- Substance Use Disorders, Health Promotion
- Keywords
- Adolescence, Parenting, School, Primary Prevention, School-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,768 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jun 1994
- Study completion
- Jun 2000
- First posted
- 19 Jun 2003 (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.
Problem behaviors such as drug use, violence, and school misconduct increase during adolescence. This study evaluated a program designed to prevent problem behaviors in middle school students; the program includes classroom instruction for students and home instruction for parents.
Detailed description
The prevalence of problem behaviors, such as school misconduct, underachievement, and dropout; tobacco, alcohol, and other drug use; and violence and delinquency, increases dramatically during adolescence. These behaviors place youths at an increased risk for school failure, involvement in the criminal justice system, and chronic substance abuse.
The purpose of this study was to test the efficacy of a comprehensive program of interventions, called Going Places, that includes participatory classroom curriculum, parent education, and enhanced school environment. The primary goal of these components was to help students learn social competence skills that will help them make positive decisions in their lives. The classroom curriculum component was integrated into the participating schools' regular Language Arts curriculum in grades 6 through 8. The curriculum provided instruction in and opportunities to practice interpersonal communication, self-management, problem solving, and conflict management. Brief videotapes with student actors served as trigger films to stimulate student interest, provide models, and motivate prosocial behavior. Parents in the participating schools received instruction via videotape and print materials and participated in student homework exercises. The emphasis was on encouraging parents to remain involved, adopt creative monitoring practices, and foster adolescent autonomy by establishing rules and conditions leading incrementally to greater independence.
Students in the seven Charles County, Maryland, middle schools were randomized either to the Going Places intervention group or to the usual education control group. The intervention was sequentially structured, with curricula implemented in each grade of middle school. Questionnaires were administered to all middle school students at the beginning of the 6th grade (before the intervention) to establish baseline levels of substance use, school misconduct, parent and peer influences, and school climate. Students completed surveys in the spring of grades 6, 7, and 8. A final follow-up survey was completed in the fall of ninth grade. The surveys assessed standard measures of tobacco, alcohol, and illicit drug use, school misconduct, and participation in school activities. The surveys also included items related to psychosocial, parental, and school factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Attends participating middle schools
- Reads at grade level
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Going Places: School program to prevent problem behavior | Behavioural | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
- Background: PubMed 12683346Simons-Morton BG, Crump AD. Association of parental involvement and social competence with school adjustment and engagement among sixth graders. J Sch Health. 2003 Mar;73(3):121-6. doi: 10.1111/j.1746-1561.2003.tb03586.x.
- Background: PubMed 12465590Simons-Morton BG. Prospective analysis of peer and parent influences on smoking initiation among early adolescents. Prev Sci. 2002 Dec;3(4):275-83. doi: 10.1023/a:1020876625045.
- Background: PubMed 11213145Simons-Morton B, Haynie DL, Crump AD, Eitel SP, Saylor KE. Peer and parent influences on smoking and drinking among early adolescents. Health Educ Behav. 2001 Feb;28(1):95-107. doi: 10.1177/109019810102800109.
- Background: PubMed 10537951Simons-Morton BG, Crump AD, Haynie DL, Saylor KE. Student-school bonding and adolescent problem behavior. Health Educ Res. 1999 Feb;14(1):99-107. doi: 10.1093/her/14.1.99.
- Background: PubMed 10048105Simons-Morton B, Crump AD, Haynie DL, Saylor KE, Eitel P, Yu K. Psychosocial, school, and parent factors associated with recent smoking among early-adolescent boys and girls. Prev Med. 1999 Feb;28(2):138-48. doi: 10.1006/pmed.1998.0404.
- Background: PubMed 10336104Simons-Morton B, Haynie DL, Crump AD, Saylor KE, Eitel P, Yu K. Expectancies and other psychosocial factors associated with alcohol use among early adolescent boys and girls. Addict Behav. 1999 Mar-Apr;24(2):229-38. doi: 10.1016/s0306-4603(98)00095-1.
- BackgroundHaynie DL, Nansel T, Eitel P, Crump AD, Saylor K, Yu K, Simons-Morton, B. Bullies, victims, and bully-victims: Distinct groups of youth at risk. Journal of Early Adolescence 21(1):95-107, 2001.
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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.
Bruce Simons-Morton, EdD, MPH principal investigator
Prevention Research Branch, Division of Epidemiology, Statistics and Prevention Research
Questions about this trial
What is this clinical trial studying?
A study testing Going Places: School program to prevent problem behavior in people with Substance Use Disorders and Health Promotion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
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 0 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 24 Jun 2005. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00062959, which also lists 7 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 24 Jun 2005.