Strongest Families Finland Canada: Family-based Prevention and Treatment Program of Early Childhood Disruptive Behavior (Fin-Can)

This study is currently recruiting participants.
Verified September 2013 by IWK Health Centre
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT01750996
First received: November 14, 2011
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

The goal of the Strongest Families Finland Canada project is to help parents develop skills to strengthen their families and reduce disruptive behavior in their 4 year old children.


Condition Intervention Phase
Behaviour Disorders (Oppositional Defiance)
Behavioral: Strongest Families
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Strongest Families Finland Canada: Family-based Prevention and Treatment Program of Early Childhood Disruptive Behavior

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Strengths & Difficulties Questionnaire (To measure change from baseline to 5 & 12 months) [ Time Frame: To measure change from baseline to 5 & 12 months ] [ Designated as safety issue: No ]
    To measure child outcome change from baseline to 5 & 12 months


Secondary Outcome Measures:
  • Depression Anxiety and Stress Scale Short Form (DASS-21)- Finnish [ Time Frame: Baseline, 5 & 12months ] [ Designated as safety issue: No ]
    Parental stress changes from baseline will be measured over time

  • CHild Behaviour Checklist (to measure change from baseline) [ Time Frame: Measure change from baseline at 5 & 12 months ] [ Designated as safety issue: No ]
    Measure of child behavioural change from baseline to 5 & 12 months

  • Alabama Parenting Questionnaire (To measure change from baseline to 5 & 21 months) [ Time Frame: To measure change from baseline to 5 & 12 months post randomization ] [ Designated as safety issue: No ]
    Measure parental parenting practice changes from baseline

  • Barkley's Quick-CHeck for Adult Attention Deficit Hyperactivity Disorder (ADHD) (to measure change from baseline) [ Time Frame: Measure change from baseline to 5&12 months ] [ Designated as safety issue: No ]
    To measure parental ADHD symptom changes form baseline

  • Child Behaviour Checklist- Teacher version (to measure change since baseline) [ Time Frame: Measure change from Baseline to 5 & 12 months ] [ Designated as safety issue: No ]
    To measure child behaviour changes at daycare from baseline to 5 & 12 months post randomization

  • Satisfaction measure [ Time Frame: 5-6months post randomization ] [ Designated as safety issue: No ]
    To measure satisfaction with Intervention and website information


Estimated Enrollment: 500
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care control (Parenting tips)
Participants randomized to usual care will have access to a brief information website containing brief parenting tips but will not receive Strongest Families Intervention
Experimental: Strongest Families
Strongest Families intervention
Behavioral: Strongest Families
Behavioural intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Child is 4 years old at time of recruitment
  • Parent/guardian has access to a computer and the internet
  • Parent/guardian is comfortable reading at a Grade 5 level
  • Child meets screening criteria (SDQ score of 4 or more with some problems per impact score)

    • Child has had behavioural challenges for the last 6 months
    • Parent has access to phone in home
    • Parent speaks/writes Finnish

Exclusion Criteria:

  • - Has received or is receiving behavioral treatment (parent training) before
  • Diagnosis of:

    • Autism or a Pervasive development disorder (PDD)
    • Down's syndrome
    • Fetal Alcohol Syndrome
    • Mental retardation
    • Genetic diagnosis that will lead to mental retardation
    • Major mental health disorder (e.g., depression, psychosis)
  • Child is not speaking using a sentence
  • Child is deaf or blind
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750996

Contacts
Contact: patricia Pottie, PhD 902-442-9521 ppottie@strongestfamilies.com
Contact: Adam Cummins 902-470-7401 acummins@iwk.nshealth.ca

Locations
Finland
University of Turku, Finland Recruiting
TUrku, Finland
Contact: Andre Sorander         
Sponsors and Collaborators
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Patrick J McGrath, PhD IWK Health Centre
  More Information

No publications provided by IWK Health Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: IWK Health Centre
ClinicalTrials.gov Identifier: NCT01750996     History of Changes
Other Study ID Numbers: CIHR# 103146
Study First Received: November 14, 2011
Last Updated: September 11, 2013
Health Authority: Canada: IWK Health Centre
Finland: Turku University Ethics Committee

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014