NCT03026335

Brief Summary

The purpose of the study is to use existing school resources and improve identification, referral and local support for children that exhibit exposure to childhood trauma resulting from environmental violence in Belize City. The Ministry of Education has identified the goals of the project to reduce violent behaviors in primary school children and supporting those children that have been exposed to violence or other malicious behavior that would inhibit normal school functioning. In addition, the MOE is supporting additional resources and data collection for a comprehensive evaluation of student behavior and academic performance.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,296

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

January 6, 2017

Last Update Submit

January 17, 2017

Conditions

Keywords

Positive Youth Development

Outcome Measures

Primary Outcomes (8)

  • Social-Emotional and Character Development Scale

    28 item self-report scale. A sum of item responses yields an overall score and sub scale scores for self-control, pro-social behavior, respect for teachers, respect for parents, honesty, and self-development. Higher scores represent improved functioning. Scores may be reported as raw, percentiles, t-scores, or normal curve equivalent scores.

    Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment

  • Peer Affiliation Scale

    7 item self-report scale. A sum of item responses yields a score ranging from 5 to 35 with higher scores representing greater affiliation with peers. Scores may be reported as raw, percentiles, t-scores, or normal curve equivalent scores.

    Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment

  • Behavior Assessment for Children (BASC)

    6 item sub scale from the BASC comprising a self-report for Anxiety, with higher scores indicting behaviors representative of anxious thought. Scores may be reported as raw, percentiles, t-scores, or normal curve equivalent scores.

    Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment

  • Substance Use and Violent Tendencies Scale

    Adapted from a CDC measure, this self-report scale contains 11 items that when summed, higher scores represent greater substance use and participation in violence. Scores may be reported as raw, percentiles, t-scores, or normal curve equivalent scores.

    Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment

  • Belief in Moral Center Scale

    An 11 item self-report measure where higher scores represent belief or adherence to social morality. Item responses are summed, and scores may be reported as raw, percentiles, t-scores, or normal curve equivalent scores.

    Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment

  • Self-Report Scale of Rewards for Pro-Social Behavior

    A 6 item self-report measure recording how much of the time Parents and Teachers notice when the respondent is nice to others. Item responses are recorded on a 4-point scale. A sum of item responses yield summary scores and may be reported as raw, percentiles, t-scores, or normal curve equivalent scores.

    Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment

  • School Self-Esteem Scale

    A 4 item self-report measure asking students how they feel about themselves with respect to school and schoolwork. Item responses are recorded on a 4-point scale. A sum of item responses yield summary scores and may be reported as raw, percentiles, t-scores, or normal curve equivalent scores.

    Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment

  • Neighborhood Youth Inventory

    A 9 item self-report measure about experiences of the respondent in their neighborhood. Item responses are recorded on a 4-point scale. A sum of item responses yield summary scores and may be reported as raw, percentiles, t-scores, or normal curve equivalent scores.

    Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment

Study Arms (2)

Positive Action Curriculum

EXPERIMENTAL

A school-wide program was implemented in the experimental schools referred to as "Positive Action" and was integrated with the existing Health and Family Life Education curriculum.

Behavioral: Positive Action

Control/Comparison Group

ACTIVE COMPARATOR

Business as usual with students in non-intervened schools

Behavioral: Control

Interventions

Positive ActionBEHAVIORAL

Based upon a Cognitive Behavioral Therapy model, intervened schools were engaged in providing curriculum, school infrastructure elements, and parent/community involvement activities around a single model aimed to provide positive support for behaviors. Six areas were identified: self-concept, body/mind, responsible self-management, treating others they way you want to be treated, telling yourself the truth, and continual improvement of self.

Positive Action Curriculum
ControlBEHAVIORAL

Business as usual with students in non-itervened schools

Control/Comparison Group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Enrolled in primary schools under the authority of the Belize Ministry of Education in the Belize District
  • Enrolled in eight grades referred to as Infant 1 and 2 (generally aged 5 and 6 years), and 1st through 6th Standard (comprising ages 7 - 12 years)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Darrell M Hull, Ph.D.

    University of North Texas Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 20, 2017

Study Start

September 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

January 20, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share