- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03026335
Childhood Resiliency Effects for School-wide Treatment in Belize City (CREST)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Belize is a country with a developing economy based primarily on agriculture and tourism. Crime and violence are emerging as a threat to the country's governance and business climate. The number of homicides in Belize have increased by more than 30% from 2003-2006. This notion of violence, in particular gang violence, is extremely concerning because the population of Belize is very young. Almost half of the population of Belize is under the age of 18. The youth of Belize are becoming engaged in criminal and delinquent behaviors at an early age that have both individual and societal consequences.
In addition to the violence rates among youth in Belize there is also an educational crisis that must be addressed. Education in Belize is compulsory between the ages of 5-14 and in 2001 93% of 5-14 year old children attended school. Although primary school is mandatory (up to age 14), only about 75% of youth complete primary school and only 25% graduate from secondary school. With few students completing high school it is likely that many may turn to gang related and other illegal activities if they are not prepared to undertake better job opportunities, have not been provided with environmental assets that protect from involvement in risky behavior, and if they are exposed to community/family values that condone gang activity. A number of studies have demonstrated that school-based interventions have moderate effects in reducing violence (average of d = .20 across studies). Combining a sound school-based intervention in Belize that is primarily targeted toward students and teachers, but combined with school-based community/family components designed to heighten awareness of the necessity of protective assets, implemented with local and international support teams, and that fosters positive norms may enhance the effects.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Positive Action Curriculum
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.
|
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.
|
ACTIVE_COMPARATOR: Control/Comparison Group
Business as usual with students in non-intervened schools
|
Business as usual with students in non-itervened schools
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social-Emotional and Character Development Scale
Time Frame: Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment
|
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
Time Frame: Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment
|
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)
Time Frame: Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment
|
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
Time Frame: Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment
|
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
Time Frame: Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment
|
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
Time Frame: Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment
|
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
Time Frame: Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment
|
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
Time Frame: Nine (9) months from the beginning of the school year until the end of the school year to coincide with treatment
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Darrell M Hull, Ph.D., University of North Texas Health Science Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 11403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Child Behavior
-
University of New MexicoActive, not recruitingChild Abuse | Parenting | Child Behavior | Child Development | Delinquency | Criminal Behavior | Child NeglectUnited States
-
Children's Hospital of PhiladelphiaPNC FoundationTerminatedChild Behavior | Child Development | Child Behavior ProblemUnited States
-
University of Southern CaliforniaSafe Water and AIDS Project (SWAP); Early Childhood Development Network for...RecruitingChild Behavior | Child Development | Language, ChildKenya
-
Windward Islands Research and Education FoundationGrand Challenges Canada; St. George's University; GRENCASECompletedDevelopment, Child | Behavior, Child | Neurocognition, ChildGrenada
-
University of PittsburghThe Grable Foundation; The Shear Family Foundation; Heinz EndowmentsRecruitingParenting | Child Development | Child Behavior Problem | Parent Child Abuse | Child LanguageUnited States
-
Children's Hospital Los AngelesNational Institute on Minority Health and Health Disparities (NIMHD)Not yet recruitingChild Behavior | Child Behavior Problem | Child Behavior Disorders | Racism
-
International Centre for Diarrhoeal Disease Research...UnknownChild Behavior | Child DevelopmentBangladesh
-
University of FloridaNational Institute of Dental and Craniofacial Research (NIDCR)Not yet recruitingChild Behavior | Behavior and Behavior Mechanisms
-
University of California, BerkeleySave the Children; Health for a Prosperous Nation; Camara Education, Tanzania; Ubongo... and other collaboratorsCompletedBehavior, Child | Behavior, Adaptive | Behavior, SocialTanzania
-
Universidad de La FronteraPlaya Ancha University; Universidad Metropolitana de Ciencias de la EducacionActive, not recruitingHealth Behavior | Behavior, ChildChile
Clinical Trials on Positive Action
-
National Institute on Drug Abuse (NIDA)CompletedSubstance Use | Violence | Academic Achievement | Pro-social Behavior | CharacterUnited States
-
Oregon State UniversityUniversity of Illinois at ChicagoCompletedSubstance Use | Violence | Academic Achievement | Character | Pro-Social BehaviorUnited States
-
University of Illinois at Urbana-ChampaignNational Heart, Lung, and Blood Institute (NHLBI)UnknownCardiovascular Risk Factor | Uncontrolled HypertensionUnited States
-
Fondazione Policlinico Universitario Agostino Gemelli...CompletedSleep Apnea, Obstructive | Fatigue | SarcoidosisItaly
-
Hospital Israelita Albert EinsteinFundação de Amparo à Pesquisa do Estado de São PauloUnknownRespiratory Distress SyndromeBrazil
-
Universidade Metodista de PiracicabaCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.CompletedRespiratory Tract Diseases | Pulmonary Atelectasis | Pathological Conditions, Signs and SymptomsBrazil
-
Daping Hospital and the Research Institute of Surgery...Unknown
-
Swiss Paraplegic Research, NottwilCompletedChronic Pain | Spinal Cord InjurySwitzerland
-
Institut Català d'OncologiaCompletedEmotional Disorder | Breastcancer | DistressSpain
-
University of Illinois at Urbana-ChampaignRosenfeld Heart Foundation GrantUnknownCardiovascular Risk Factor | Uncontrolled HypertensionUnited States