Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00328445
Other study ID # R01DA013474
Secondary ID
Status Completed
Phase N/A
First received May 19, 2006
Last updated January 11, 2017
Start date April 2001
Est. completion date June 2006

Study information

Verified date September 2014
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of the Positive Action program on reducing negative behaviors, increasing positive behaviors and improving academic achievement of elementary school students.


Description:

This project will: 1) evaluate the efficacy of a comprehensive, multi-grade, multi-year program, the Positive Action program (PA) designed to reduce student problem behaviors (including drug use and violence), disciplinary referrals and suspensions, and academic underachievement; 2) evaluate the effects of the program on the presumed/theoretical mediator variables; and 3) assess which of these changes in mediator variables actually mediate the effects of the program on behavior and school performance. The Hawaiian school district has agreed to implement a randomized trial of the PA program. We randomly assigned schools to PA or control conditions from strata matched on multiple indicators of risk. PA schools will receive the full PA program for four years (the 2002-03 through 2005-06 school years). This includes all materials for all students (at all grades), families, teachers, and principal, plus community kits; training for teachers and other interested staff; and continuous technical support and monitoring by a PA staff person. Data on behavior and academic achievement will be obtained from school archival records for all students for all years and, where appropriate for several years prior to the study. Students in grades 1 and 3 in the 2001-02 school year and their parents and teachers will also be followed through the project with surveys every year. The subject population will contain equal portions of males and females, and proportionate numbers of the major ethnic groups on Oahu (Hawaiian or part-Hawaiian, white, Asian, Other). Analyses will test for program effects on all hypothesized mediating variables and outcomes, and the hypothesized mediational pathways.


Recruitment information / eligibility

Status Completed
Enrollment 2500
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years and older
Eligibility Inclusion Criteria:

- Public elementary schools K-5 or K-6

- All students in the study cohorts

Exclusion Criteria:

- Schools performing in top 50%

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Behavioral:
Positive Action
See publications

Locations

Country Name City State
United States University of Illinois at Chicago Chicago Illinois
United States Oregon State University Corvallis Oregon
United States Positive Action, Inc. Twin Falls Idaho

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Beets MW, Flay BR, Vuchinich S, Acock AC, Li KK, Allred C. School climate and teachers' beliefs and attitudes associated with implementation of the positive action program: a diffusion of innovations model. Prev Sci. 2008 Dec;9(4):264-75. doi: 10.1007/s11121-008-0100-2. — View Citation

Beets MW, Flay BR, Vuchinich S, Snyder FJ, Acock A, Li KK, Burns K, Washburn IJ, Durlak J. Use of a social and character development program to prevent substance use, violent behaviors, and sexual activity among elementary-school students in Hawaii. Am J — View Citation

Snyder F, Flay B, Vuchinich S, Acock A, Washburn I, Beets M, Li KK. Impact of a social-emotional and character development program on school-level indicators of academic achievement, absenteeism, and disciplinary outcomes: A matched-pair, cluster randomiz — View Citation

Snyder FJ, Vuchinich S, Acock A, Washburn IJ, Flay BR. Improving elementary school quality through the use of a social-emotional and character development program: a matched-pair, cluster-randomized, controlled trial in Hawai'i. J Sch Health. 2012 Jan;82( — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported attitudes and behaviors 2001-2006 No
Primary Teacher reports of behaviors 2001-2006 No
Primary Parent reports of student behaviors 2001-2006 No
Secondary School-level academic achievement test scores 2000-2007 No
Secondary School-level reports of disciplinary referrals 2000-2007 No
Secondary School-level reports of school quality 2000-2007 No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05806840 - Rapid Adaptation to Prevent Drug Use N/A
Recruiting NCT06003725 - Cultural Adaptation of Drug Treatment for DJJ Youth N/A
Recruiting NCT05414344 - A Brief Intervention for Alcohol Users With Interpersonal Trauma N/A
Recruiting NCT05768815 - Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright N/A
Completed NCT05606601 - An Online Intervention Addressing Mental Health and Substance Use in University Students N/A
Completed NCT03489434 - Technology-Based Prevention for Adolescents in Primary Care N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Recruiting NCT05899101 - The Impact of Opioid and Cannabis Exposure on Fetal Growth
Completed NCT02990026 - Specialty Mental Health Probation in North Carolina N/A
Not yet recruiting NCT06116266 - Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care) N/A
Not yet recruiting NCT03249428 - E-Cigarette Inner City RCT N/A
Active, not recruiting NCT03129334 - Preventing Prescription Drug Abuse in Middle School Students N/A
Completed NCT04183400 - Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness N/A
Completed NCT02112201 - The ProGirls Study N/A
Completed NCT01752998 - Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings N/A
Terminated NCT01661517 - Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting Phase 0
Completed NCT01511380 - Targeting HIV Risk Behaviors in Juvenile Drug Court-Involved Youth Phase 2
Completed NCT01351454 - Behavioral Depression Treatment for African American HIV-infected Substance Users N/A
Completed NCT01154309 - Group CBT for Depression and AOD Disorders Phase 1
Completed NCT00996541 - Support To Reunite Involve and Value Each Other N/A