Condition category
Mental and Behavioural Disorders
Date applied
20/06/2011
Date assigned
29/07/2011
Last edited
29/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The social and economic costs of teen violence and aggression are substantial and rising. Despite recent progress, further research is needed to develop interventions for pre-teens and adolescents, particularly those at the highest level of risk. Few programs have addressed the relevance of gender differences, and important questions remain regarding the need for 'gender sensitive', 'gender tailored' or 'gender specific' programming. Programs that promote and strengthen relationships between youth and their parents may enhance healthy development and reduce violence, aggression and related mental health and social problems. We have developed an intervention to strengthen parent-teen relationships. The aim of this study is to evaluate the short- and long-term effectiveness of this program for girls and boys at high risk for aggression, violence and poor social and mental health.

What does the study involve?
Youth (aged 13 -16 years of age) with serious conduct problems and their caregivers (biological, adoptive and stable surrogate parents)

What does the study involve?
Parent and youth pairs are randomly allocated to receive either treatment as usual or a 10-week parent-teen attachment intervention. The effectiveness of the intervention, compared with treatment as usual, is assessed at 6-month intervals over a one-year period.

What are the possible benefits and risks of participating?
Caregivers or youth may sometimes feel a little upset when talking about problems, but other than this there are no other risks we can foresee.

Where does the study take place?
Simon Fraser University (Canada)

When is the study starting and how long is it expected to run for?
September 2011 to June 2014

Who is funding the project?
Canadian Institutes for Health Research (Canada)

Who is the main contact?
Dr Marlene Moretti

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marlene Moretti

ORCID ID

Contact details

8888 University Drive
Burnaby
V5A1S6
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Strengthening parent-teen relationships to reduce risk and enhance healthy development: a sex and gender framework in translating research into practice

Acronym

Study hypothesis

1. Evaluate the effectiveness of a parent-teen attachment based intervention for girls and boys compared to ‘treatment usual’ using a randomized control design, with a one year follow-up period
2. Examine the role of sex and gender in relation to factors that mediate therapeutic gains(attachment security) and moderate treatment outcome (genetic markers)
3. Investigate sex and gender in relation to mechanisms that underlie treatment change: shifts in parenting representations and adolescent stress reactivity

Ethics approval

Simon Fraser Research Ethics Board, submitted June 2011

Study design

Single-centre randomized 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

High risk for aggression, violence and poor social and mental health

Intervention

1. A 10-week attachment-focused intervention program for parents or parental surrogates of teens who engage in aggressive, violent, and antisocial behaviour
2. During the enrolment period, all parents seeking clinical services at designated mental health facilities will be provided with information about the trial and invited to participate
3. Following completion of informed consent by parents and assent by youth, parents will complete screening to determine eligibility
4. Eligible parent-youth dyads will be randomly assigned to either the intervention, a 10 week manualized parent-teen attachment intervention - Connect, or “treatment as usual” (TAU)
5. Parents and youth will complete measures prior to and following treatment, and twice afterwards at six-month intervals post-treatment
6. Caregivers allocated to the intervention arm will attend a 10-week, manualized, attachment-focused parent group
7. Each 1 hour session will Address an attachment principle that captures key aspects of the parent-teen relationship and common parenting challenges
8. The objective of the intervention is to enhance skills related to:
8.1. Secure attachment
8.2. Parental sensitivity
8.3. Partnership and mutuality
8.4. Dyadic affect regulation
9. Treatment as Usual (TAU) Characteristics: Clinics included in the trial also offer an array of services for families, parents and teens
10. TAU is available at each participating mental health centre and will include other forms of parenting groups, family therapy, parent or youth cognitive therapy or supportive counselling
11. Treatment duration is typically short (3-4 months)
12. We will code treatment dose in both treatment conditions in terms of total number of sessions attended, total weeks of treatment, average length of sessions, and total hours in treatment

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Parent report: Brief Child and Family Phone Interview (BCFPI)
2. Three measures of parenting: The Parenting Sense of Competence Scale (PSOC)
3. The Children’s Report of Parenting Behaviors Inventory (CRPBI)
4. The Caregiver Strain Questionnaire (CGSQ) which measures: the Comprehensive Adolescent-Parent Attachment Inventory – Parent Version (CAPAI-P)
5. You report: BCFPI
6. The Self Report of Offending-Revised (SRO-R)
7. The Conflict Tactics Scale – Perpetrator subscale (CTS)
8. The Affect Regulation Checklist (ARC): The Comprehensive Adolescent-Parent Inventory – Youth Version (CAPAI-Y)

Secondary outcome measures

1. Parent report: The Parenting Representations Interview – Adolescence version
2. Youth biological stress reactivity (salivary cortisol)
3. Genotype moderation (DRD4)
4. Official arrest data
5. Grade point average and absenteeism
6. Other services received

Overall trial start date

01/09/2011

Overall trial end date

01/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. English-speaking
2. Parent-youth dyads of youth diagnosed with conduct disorder (t-score of ≥ 65, BCFPI)
3. Available (i.e. no anticipated extended absences)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Cases that are positive for acute psychosis
2. Imminent risk of suicide will be ineligible and will be referred for immediate alternative services

Recruitment start date

01/09/2011

Recruitment end date

01/06/2014

Locations

Countries of recruitment

Canada

Trial participating centre

Simon Fraser University
Burnaby
V5A1S6
Canada

Sponsor information

Organisation

Simon Fraser University (Canada)

Sponsor details

8888 University Drive
Burnaby
V5A1S6
Canada

Sponsor type

University/education

Website

http://www.sfu.ca/

Funders

Funder type

Government

Funder name

Canadian Institutes of Health Research

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

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

Publication citations

Additional files

Editorial Notes

29/07/2016: Plain English summary added.