Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David A Wolfe

ORCID ID

Contact details

CAMH Centre for Prevention Science
100 Collip Circle Suite 100
London
N6G 4X8
Canada
+1 519 858 5161
dawolfe@uwo.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-66913

Study information

Scientific title

Controlled longitudinal evaluation of a school based program to prevent adolescent dating violence and related risk behaviours: a randomised controlled trial

Acronym

Study hypothesis

This trial will evaluate a school-based intervention designed to address the problems of dating violence, substance abuse, and high-risk sexual behaviour as they emerge in the context of relationships over the course of high school transitions (grades 9 - 11). We hypothesise that youths receiving the Comprehensive School-Based Intervention (CSBI), relative to standard-intervention controls, will show less abusive and more positive behaviour with dating partners and peers over time. Intervention youth will also demonstrate safer choices with respect to sexual behaviour and substance use as measured by our risk index. Risk behaviours will be measured by a Comprehensive Adolescent Risk Index reflecting violence toward dating partners, violence towards peers, unsafe sexual behaviour, and substance use. Secondary aims of the study include higher levels of school connectedness among students, and positive perceptions of teachers and parents on the impact of the intervention on students.

Ethics approval

Centre for Addiction and Mental Health Research Ethics Board approved on the 19th April 2004

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dating violence and related risk behaviours

Intervention

Intervention (Comprehensive School Based Intervention)/Control (standard health curricula). CSBI involves a whole school approach with extensive teacher training, parent education, and schoolwide events. The cornerstone of the intervention is an intensive 21-session classroom curriculum. The curriculum emphasises skill-building exercises, and expands this approach in an integrated manner to prevention of violence in relationships and unsafe sexual behaviours. The curriculum is embedded within a comprehensive and ongoing initiative that includes: schoolwide activities to promote positive relationships and prevent violence and abuse; information sharing with parents to encourage positive adolescent choices in these areas; exposure to community resources that promote healthy adolescent choices; school-wide campaigns related to substance use, sexual behaviour and violence; and training for all school personnel. In addition, a student-led Social Action Committee will be formed at each CSBI school.

School-level interventions will include yearly teacher awareness education for the entire staff, information for all staff on the fundamentals of the program, and supplementary activities, such as theatre presentations and guest panels for all grades. Parents will be provided with information about the program during Grade 9 orientation; written information about the program and about developmental changes during adolescence; and suggested parenting strategies and community resources for parents with teens.

The control condition involves existing curricula. Based on a sample of questionnaires collected from teachers and interviews with key stakeholders, the status quo condition involved less class time (particularly in the area of violence prevention), and didactic information delivery, with minimal skill-building, school, parent, or community components.

Trial details received: 12 Sept 2005.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Students’ scores on the Comprehensive Adolescent Risk Index (CARI), a self-report behavioural risk index that was developed and validated during the pilot phase of this program. The CARI is generated by classifying students into low, medium and high risk groups in the areas of dating violence, peer violence, substance use, and sexual behaviour. The scores in each domain (0, 1 or 2) are added to generate the CARI score, which ranges from 0 - 8. The primary outcomes were measured at the beginning and end of Grade 9 (2004/2005) and will be measured again two years later, at the end of Grade 11 (2007).

Secondary outcome measures

The secondary outcomes were measured at the beginning and end of Grade 9 (2004/2005) and will be measured again two years later, at the end of Grade 11 (2007). Secondary outcomes that will be evaluated on an exploratory basis include acquisition of interpersonal relationship skills, school connectedness, and official school record indicators. Acquisition of interpersonal skills will be assessed with a behavioural analog paradigm at the end of Grade 9, with a random subsample of students drawn from some of the schools. The analog will involve role-playing a conflict scenario with an older, opposite-sex student who has been trained by the researchers. The scenarios will be similar to those included in the curriculum, and will represent typical adolescent interpersonal conflicts related to triad behaviours (sex, substance use, and violence). The role plays will be videotaped and participants’ interaction will be coded. School connectedness will be measured with a 5-item self-report scale that was developed for the US National Adolescent Health Survey. Official school indicators of incident reports and suspension records will also be obtained.

Overall trial start date

01/09/2004

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

School eligibility includes a willingness:
1. To be involved in teacher training, curriculum delivery, and school-wide implementation over 4 years (if required)
2. To facilitate the evaluation of all components of the study over 4 years
3. To participate in a randomised trial
To be eligible, the school also has to provide faculty and principal approval of the curriculum and evaluation, and to agree not to introduce other related programs during the 4-year study.

There are no eligibility requirements at the individual student level because all Grade 9 students attending a demonstration school will receive the intervention (Physical Health and Education is mandatory). Participants will be adolescents, aged 15 - 16 years old (grade nine), either sex.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1507 (1722 in final sample as of 16/05/08)

Participant exclusion criteria

A school is ineligible for the trial if it was involved in the pilot phase of the program or has implemented similar curricula.

Recruitment start date

01/09/2004

Recruitment end date

30/06/2009

Locations

Countries of recruitment

Canada

Trial participating centre

CAMH Centre for Prevention Science
London
N6G 4X8
Canada

Sponsor information

Organisation

Centre for Addiction and Mental Health (Canada)

Sponsor details

100 Collip Circle
Suite 100
London
N6G 4X8
Canada
+1 519 858 5144
David_wolfe@CAMH.net

Sponsor type

Hospital/treatment centre

Website

http://www.camh.net/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-66913)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19652099

Publication citations

  1. Results

    Wolfe DA, Crooks C, Jaffe P, Chiodo D, Hughes R, Ellis W, Stitt L, Donner A, A school-based program to prevent adolescent dating violence: a cluster randomized trial., Arch Pediatr Adolesc Med, 2009, 163, 8, 692-699, doi: 10.1001/archpediatrics.2009.69.

Editorial Notes