How early individual characteristics and family environment interact in the development and prevention of externalizing problems across early school years
| ISRCTN | ISRCTN17624073 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17624073 |
| Protocol serial number | MOP – 143049 |
| Sponsor | Canadian Institutes of Health Research |
| Funder | Canadian Institutes of Health Research |
- Submission date
- 26/08/2016
- Registration date
- 01/09/2016
- Last edited
- 12/12/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Disruptive behaviors such as hyperactivity, aggression, oppositional (challenging) and conduct problems are among the most common behavioral and mental health problems in childhood. These problems are often jointly referred to as externalizing disorders (EDs), the most common of which are such as ADHD and conduct disorder. EDs are widespread, prolonged, and costly to society. If a child is suffering from an ED, then they are more likely to develop mental health problems as an adult, as well as more prone to substance use disorders, school-drop out, crime and violence. It is possible for children to have more than one ED, as they often share common risk factors. Targeting these risk factors therefore could provide an opportunity for prevention. The Community Parent Education Program (COPE) is a new parent training program, designed to help parents develop skills to strengthen their relationships with their children, increase cooperation and solve problems. The aim of this study is to investigate the effectiveness of COPE at preventing disruptive behavior and improving mental health in children.
Who can participate?
Parents of children aged 4 and 5 years who have problems controlling their behaviour, who previously participated in the “Découvrir, Développer, Devenir” (3D) Study.
What does the study involve?
At the start of the study, participants are asked to complete an online questionnaire twice, about 6 months apart, which should take around 90 minutes to complete. Parents and children are also invited to complete a series of computer and other games at home. Each home visit will take 60 minutes maximum. Participants are asked to provide the name and contact details of a person that knows your child well but who does not live with them (e.g. educator, caregiver, extended family member or friend), to invite him/her to complete an online questionnaire about the child’s personality and behaviour. Families are then randomly allocated to one of two groups. Those in the first group are invited to participate in a parent-training program (COPE), which consists of 10 weekly two hour group sessions. Each of the 10 weekly sessions of 2 hours addresses different topics related to early child behaviour and parental problem-solving strategies. Those in the second group continue as normal for the duration of the study. At the end of the study, the questionnaires from the start of the study are repeated to find out if there has been any change to the child’s behavior.
What are the possible benefits and risks of participating?
Parents who are allocated to the COPE group benefit from 10 free sessions of a program delivered by trained facilitators that has been shown to be effective in improving parenting skills and reducing behavioural problems and/or attention problems in children 3 to 12 years old. There are no notable risks involved with taking part in this study.
Where is the study run from?
1. Université de Montréal (Canada)
2. Sainte Justine Hospital (Canada)
When is the study starting and how long is it expected to run for?
January 2016 to December 2017
Who is funding the study?
Canadian Institutes of Health Research (Canada)
Who is the main contact?
Dr Natalie Castellanos Ryan
Contact information
Scientific
École de Psychoéducation
Université de Montréal
Pavillon Marie-Victorin, Bureau C-414
90, av. Vincent-d'Indy, Outremont
Quebec
Montreal
H2V 2S9
Canada
 ORCID ID |
0000-0002-7077-1340 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre open-label randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Using a randomized control trial to test developmental models of individual factors by environment interaction in the prediction of externalizing psychopathology across early school years |
| Study acronym | 3D Transition RCT |
| Study objectives | Compared to children of parents randomised to a no-intervention control condition, children of parents randomized to a parent-skills training intervention will have fewer externalising symptoms and diagnoses at post-test (2 months post-intervention). |
| Ethics approval(s) | Le Comité d’éthique de la recherche du CHU Sainte-Justine (Sainte Justine hospital research ethics committee), 09/08/2016, ref: 2016-1143 |
| Health condition(s) or problem(s) studied | Externalising disorders |
| Intervention | Once parents consent to the study, they will complete a baseline questionnaire and assessment and be randomised to an intervention or control condition (simple randomization, at a ratio of 1:1) using a computer-generated random numbers list. Intervention arm: Parents will receive the Community Parent Education Program (COPE) delivered at Ste Justine Hospital or other premises of the Université de Montréal. The COPE is manual-based and designed to help parents develop proven skills to strengthen their relationships with their children, increase cooperation and solve problems. COPE is a group-based program of 10-20 parents, who will meet with one or two trained facilitators for 10 weekly 2-hour sessions (so total duration 10 weeks). Control arm: Parents will not receive any intervention or treatment. Both groups will be assessed about 6 months post-randomization (roughly 2 months post-intervention for intervention participants). |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Externalizing symptoms (i.e., conduct disorder, Attentional Deficit and Hyperactivity Disorder (ADHD) and Oppositional Defiance Disorder (ODD) symptoms) are measured using the Strengths and Difficulties Questionnaire (SDQ) and the Social Behavior Questionnaire, rated by the parent and another person “most knowledgeable of the child outside the family” (e.g. teachers) at baseline and 6 months. |
| Key secondary outcome measure(s) |
1. Child temperament is measured by parent-reported Children’s Behavior Questionnaire at baseline and 6 months |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 250 |
| Key inclusion criteria | 1. Parent-child dyads who have taken part in the “Découvrir, Développer, Devenir” (3D) Study (a large pregnancy study that collected data across pregnancy and the first two years of the child’s life of 1594 mothers and their children. IRNPQEO: http://www.irnpqeo.ca/) 2. Children who score low on parent-reported self-regulation at 2 years of age (i.e. score below the mean reported in the 3D sample) |
| Key exclusion criteria | Not meeting inclusion criteria |
| Date of first enrolment | 06/09/2016 |
| Date of final enrolment | 01/05/2017 |
Locations
Countries of recruitment
- Canada
Study participating centres
Pavillon Marie-Victorin
90, av. Vincent-d'Indy
Outremont
Montreal
H2V 2S9
Canada
Montréal
H3T 1C4
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/12/2018: The overall trial end date was changed from 31/12/2017 to 31/12/2019.
