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23 February 2012
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| [ Print-friendly version ] |
| Reducing violence and victimization in at-risk adolescent girls and boys |
| ISRCTN | ISRCTN61995733 |
| ClinicalTrials.gov identifier | |
| Public title | Reducing violence and victimization in at-risk adolescent girls and boys |
| Scientific title | Effectiveness of a relational intervention in reducing violence and victimization in at-risk adolescent girls and boys |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
1. Adolescents whose caregivers participate in the intervention will engage in lower levels of aggressive behaviour and will experience lower levels of victimization at the end of the intervention and at regular follow-up assessmentts compared to youth whose caregivers did not participate in the intervention.
2. Parent-adolescent attachment security will increase from pre- to post-intervention and at regular follow-ups for those who complete the intervention program, compared to parents and adolescents in the no-intervention comparison condition. 3. Puberty onset will moderate intervention outcomes such that reductions in aggression, violence, and victimization will be greatest for girls and boys with earlier puberty. In addition, we predict that intervention outcomes will be even more pronounced for girls with earlier puberty than for boys with earlier puberty. 4. Among adolescents whose parents receive intervention, youth with specific genetic markers will show greater reductions in aggression compared to youth without these genetic markers. Conversely, among adolescents whose parents do not receive intervention, those with particular genetic markers will show greater increases in aggression and compared with youth without them. 5. Changes in parent-adolescent attachment security from pre- to post-intervention will mediate reductions in violence and victimization immediately post-intervention and at regular follow-ups. 6. Gender differences in the attachment processes that underlie intervention outcomes will be explored based on evidence that girls’ reductions in aggressive and violent behaviour are related to a reduction in attachment anxiety, while boys’ reductions in aggressive behaviour are related to a reduction in attachment avoidance. 7. Adolescents’ prior exposure to stress exposure will be associated with blunted cortisol responses at pre-intervention. 8. Normalization of stress reactivity will mediate reductions in aggressive behaviour from pre- to post-intervention and at regular follow-ups. 9. There will be reduced activity in ventral PFC in response to emotional stimuli among youth of parents in the intervention condition, compared to no change in the comparison condition. 10. Reduced activity in ventral PFC will mediate intervention reductions in aggressive behaviour as measured immediately following intervention and at regular follow-ups. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Not provided at time of registration |
| Study design | Single centre randomized controlled trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | At risk for aggression, violence and poor mental health |
| Participants - inclusion criteria |
1. English speaking
2. Parent-youth dyads of adolescents (community sample) at risk for significantly elevated levels of aggression and violence 3. Available to attend all intervention program components and follow-ups |
| Participants - exclusion criteria | Imminent risk of suicide will be ineligible and referred for immediate mental health services |
| Anticipated start date | 01/09/2012 |
| Anticipated end date | 31/08/2017 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 700 |
| Interventions |
1. A 10-week attachment-focused intervention program (Connect) for parents or parental surrogates of teens who engage in aggressive, violent, and antisocial behaviour.
2. Following completion of informed consent by parents and assent by youth, parents will complete screening (described below) to determine eligibility. 3. During the screening and enrolment period, participants in the community will be identified and recruited in a multi-stage screening process conducted across three cohorts of youth over three consecutive school years. Primary schools within a large urban area will participate to ensure the required screening sample of N=7,000. Adolescents who self-identify and are identified by parents or alternate caregivers as highly aggressive will be invited to participate in screening. Those who score in the top 40% of the screening measure will be eligible for the Stage 2 screen. The Stage 2 screen will consist of having primary caregivers complete the self-report of the Problem Frequency Behaviour Frequency Scale-Aggression, rating their adolescent. A final risk score will be obtained by standardizing scores on the youth- and parent-report screens within sex, and then combining the two scores. We will invite approximately the top 14-16% of these youth and their families to participate in the RCT phase of the project. During the enrolment period, parents of eligible youth indicating interest in participating will be provided with information about the program and invited to participate. This information will be presented in evening group sessions at local schools, and with individual follow-up sessions as needed. 4. Eligible parent-youth dyads will be randomly assigned to either the intervention, a 10 week manualized parent-teen attachment intervention - Connect, or a no-intervention comparison condition. 5. Parents and youth will complete measures prior to and following treatment, and three sessions afterwards at six-month intervals post-treatment. 6. Each 1 hour intervention session will address an attachment principle that captures key aspects of the parent-teen relationship and common parenting challenges. 7. The objective of the intervention is to enhance skills related to: 7.1. Secure attachment 7.2. Parental sensitivity 7.3. Partnership and mutuality 7.4. Dyadic affect regulation |
| Primary outcome measure(s) |
1. The Comprehensive Adolescent-Parent Attachment Inventory – Parent Version (CAPAI-P)
2. The Comprehensive Adolescent-Parent Inventory – Youth Version (CAPAI-Y) 3. The Children’s Report of Parenting Behaviors Inventory (CRPBI) 4. The Caregiver Strain Questionnaire (CGSQ) 5. Parental Support for Fighting Scale (PSFS) 6. Problem Behavior Frequency Scale – Aggression and Victimization (Youth report) 7. The Conflict Tactics Scale – Perpetrator subscale (CTS; youth and parent report) 8. The Affect Regulation Checklist (ARC; parent and youth report) 9. Youth Self-Report (YSR) Externalizing scale 10. Normative Beliefs About Aggression Scale 11. Attitudes Towards Aggression in Dating Situations Scale 12. Child Behavior Checklist (CBCL) Externalizing and Internalizing scales (Parent report about adolescent) |
| Secondary outcome measure(s) |
1. The Parenting Representations Interview
2. Youth biological stress reactivity (salivary cortisol) 3. Genotype moderation (DRD4) 4. Grade point average |
| Sources of funding | Canadian Institutes of Health Research (Canada) (ref: 251560) |
| Trial website | |
| Publications | |
| Contact name | Dr Marlene Moretti |
| Address | 8888 University Drive |
| City/town | Burnaby, B.C. |
| Zip/Postcode | V5A 1S6 |
| Country | Canada |
| Sponsor | Simon Fraser University (Canada) |
| Address | 8888 University Drive |
| City/town | Burnaby, B.C. |
| Zip/Postcode | V5A 1S6 |
| Country | Canada |
| Sponsor website: | http://www.sfu.ca/ |
| Date applied | 22/12/2011 |
| Last edited | 27/01/2012 |
| Date ISRCTN assigned | 27/01/2012 |
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| © 2012 ISRCTN unless otherwise stated. | |
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