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

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ClinicalTrials.gov Identifier: NCT01750996
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : September 2, 2016
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
IWK Health Centre

Brief Summary:
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 or disease Intervention/treatment Phase
Disruptive Behavior Disorder Behavioral: Strongest Families Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 464 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Strongest Families Finland Canada: Family-based Prevention and Treatment Program of Early Childhood Disruptive Behavior
Study Start Date : October 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. CHild Behaviour Checklist (to measure change from baseline) [ Time Frame: Measure change from baseline at 6 & 12 months ]
    Measure of child behavioural change from baseline to 6 & 12 months


Secondary Outcome Measures :
  1. Depression Anxiety and Stress Scale Short Form (DASS-21)- Finnish [ Time Frame: Baseline, 6 & 12months ]
    Parental stress changes from baseline will be measured over time

  2. The Parenting Scale (To measure change from baseline to 6 & 21 months) [ Time Frame: To measure change from baseline to 6 & 12 months post randomization ]
    Measure parental parenting practice changes from baseline

  3. Barkley's Quick-Screen: The Barkley Adult ADHD Rating Scale IV (to measure change from baseline) [ Time Frame: Measure change from baseline to 6&12 months ]
    To measure parental ADHD symptom changes form baseline

  4. Child Behaviour Checklist- Teacher version (to measure change since baseline) [ Time Frame: Measure change from Baseline to 6 & 12 months ]
    To measure child behaviour changes at daycare from baseline to 6 & 12 months post randomization

  5. Satisfaction measure: Researcher designed for the Intervention group [ Time Frame: end of program intervention (average is about 5 months but timing of completion varies between participants.) ]
    To measure satisfaction with Intervention and website information

  6. Strengths & Difficulties Questionnaire (Screening Tool) [ Time Frame: Screening ]
    Screening tool used to identify high risk 4 year olds

  7. The Parent Problem Checklist [ Time Frame: Measure change from Baseline to 6 & 12 months ]
    To measure interparental conflict

  8. The Sense of Coherence Scale (SOC-13) [ Time Frame: Measure change from Baseline to 6 & 12 months ]
    To measure parent's sense of coherence (i.e., global view of the world, and individual environment as comprehensible, manageable and meaningful)

  9. The Inventory of Callous-Unemotional Traits [ Time Frame: Measure change from Baseline to 6 & 12 months ]
    To measure child empathy



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Ages Eligible for Study:   4 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750996


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

Publications of Results:
Other Publications:
Responsible Party: IWK Health Centre
ClinicalTrials.gov Identifier: NCT01750996     History of Changes
Other Study ID Numbers: CIHR# 103146
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Aggregate summary data would be made available but not individual data.

Additional relevant MeSH terms:
Mental Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Behavioral Symptoms
Neurodevelopmental Disorders