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

This study is ongoing, but not recruiting participants.
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: July 23, 2015
Last verified: July 2015
  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
Disruptive Behavior Disorder
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:
  • CHild Behaviour Checklist (to measure change from baseline) [ Time Frame: Measure change from baseline at 6 & 12 months ] [ Designated as safety issue: No ]
    Measure of child behavioural change from baseline to 6 & 12 months


Secondary Outcome Measures:
  • Depression Anxiety and Stress Scale Short Form (DASS-21)- Finnish [ Time Frame: Baseline, 6 & 12months ] [ Designated as safety issue: No ]
    Parental stress changes from baseline will be measured over time

  • 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 ] [ Designated as safety issue: No ]
    Measure parental parenting practice changes from baseline

  • 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 ] [ 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 6 & 12 months ] [ Designated as safety issue: No ]
    To measure child behaviour changes at daycare from baseline to 6 & 12 months post randomization

  • Satisfaction measure: Researcher designed for the Intervention group [ Time Frame: End of intervention and 12 months ] [ Designated as safety issue: No ]
    To measure satisfaction with Intervention and website information

  • Strengths & Difficulties Questionnaire (Screening Tool) [ Time Frame: Screening ] [ Designated as safety issue: No ]
    Screening tool used to identify high risk 4 year olds

  • The Parent Problem Checklist [ Time Frame: Measure change from Baseline to 6 & 12 months ] [ Designated as safety issue: No ]
    To measure interparental conflict

  • The Sense of Coherence Scale (SOC-13) [ Time Frame: Measure change from Baseline to 6 & 12 months ] [ Designated as safety issue: No ]
    To measure parent's sense of coherence (i.e., global view of the world, and individual environment as comprehensible, manageable and meaningful)

  • The Inventory of Callous-Unemotional Traits [ Time Frame: Measure change from Baseline to 6 & 12 months ] [ Designated as safety issue: No ]
    To measure child empathy


Estimated Enrollment: 500
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
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: July 23, 2015
Health Authority: Canada: Institutional Review Board
Finland: Ethics Committee

Additional relevant MeSH terms:
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on July 30, 2015