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

Primary Purpose

Disruptive Behavior Disorder

Status
Completed
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
Strongest Families
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Disruptive Behavior Disorder

Eligibility Criteria

4 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Turku, Finland

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care control (Parenting tips)

Strongest Families

Arm Description

Participants randomized to usual care will have access to a brief information website containing brief parenting tips but will not receive Strongest Families Intervention

Strongest Families intervention

Outcomes

Primary Outcome Measures

CHild Behaviour Checklist (to measure change from baseline)
Measure of child behavioural change from baseline to 6 & 12 months

Secondary Outcome Measures

Depression Anxiety and Stress Scale Short Form (DASS-21)- Finnish
Parental stress changes from baseline will be measured over time
The Parenting Scale (To measure change from baseline to 6 & 21 months)
Measure parental parenting practice changes from baseline
Barkley's Quick-Screen: The Barkley Adult ADHD Rating Scale IV (to measure change from baseline)
To measure parental ADHD symptom changes form baseline
Child Behaviour Checklist- Teacher version (to measure change since baseline)
To measure child behaviour changes at daycare from baseline to 6 & 12 months post randomization
Satisfaction measure: Researcher designed for the Intervention group
To measure satisfaction with Intervention and website information
Strengths & Difficulties Questionnaire (Screening Tool)
Screening tool used to identify high risk 4 year olds
The Parent Problem Checklist
To measure interparental conflict
The Sense of Coherence Scale (SOC-13)
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
To measure child empathy

Full Information

First Posted
November 14, 2011
Last Updated
September 1, 2016
Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01750996
Brief Title
Strongest Families Finland Canada: Family-based Prevention and Treatment Program of Early Childhood Disruptive Behavior
Acronym
Fin-Can
Official Title
Strongest Families Finland Canada: Family-based Prevention and Treatment Program of Early Childhood Disruptive Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This project will have two phases, described below. The first part will be development of the web based program, the second part will be the implementation of the program in Finland. All participants will be recruited in Finland and all research activities will take place in Finland, by the Finnish Consortium. The Canadian Consortium will assist in funding and provide expert support. Part 1: Website development: The Strongest families program provides evidence based psychological and behavioural interventions to families with children with mild to moderate mental health problems. Parents work through a handbook with exercises, watch instructional videos and participate in weekly phone calls from a trained 'coach' (paraprofessional) to provide support, respond to parents' questions and highlight the skills included in a handbook. The preliminary analysis of a Strongest Families effectiveness trial based at the Izaak Walton Killam Children's Hospital (IWK) Health Centre (Projects #2234, and #2654) and effect size reports from the IWK Strongest families Service Program suggest that Strongest Families is an effective treatment for Oppositional Defiant Disorder (ODD). Strongest Families is an adaptation of the COPE program. COPE is a large-group parent training program (average 25 families per group) that has been evaluated and used in many centres across Canada, the United States and Europe. It was developed at McMaster University by a team led by Dr. Charles Cunningham (one of the investigators on this submission). The groups use a coping modelling problem solving approach to skill acquisition which encourages parents to discuss the solution to common problems, collaborate in the formulation of child management strategies, share successes, and provide supportive feedback. Large group discussions may also provide more information regarding normal child development and a greater perspective on common child management difficulties than clinic/individual parent training . The benefits for parents participating in COPE group sessions are many, but the burden of traveling to receive services can impede attendance, especially for families in rural areas. One solution to this issue would be to adapt individualized Strongest Families to a more accessible mode. We propose to develop a web-based version of Strongest Families in preparation for a Randomized Control Trial (RCT) in Finland. All components of web site will be developed using a collaborative approach with active participation by all members of the research team. We will review each of the component as it is developed. We estimate a minimum of three rounds of testing for each component. The program will be evaluated using the user-interface so that we review the website and all its various features in a manner that simulates the actual parent experience. No qualitative or quantitative data will be recorded for this phase of the project. No participants will be recruited for this phase of the trial. The web version of Strongest Families will have two components. First, is a personalized website that tracks and uses all activities and interactions to modify the Strongest Families intervention as the user progresses through the sessions. Interactions include questions, surveys, and polls which will be asked periodically throughout the program (for examples see Appendix A). Second, the parenting skills curriculum will be based on our Strongest Families program, an approach derived from programs developed by members of this team18,19. Third, parents , using pseudonyms, will participate in a discussion board/blog to exchange ideas. Pseudonyms will be chosen by the participant, but will not include any identifying elements. Part 2: Randomized trial (Conducted in Finland, no Canadian recruitment) The centerpiece project will be a population-based RCT of high risk 4 year olds attending well-child clinics in Turku and environs. Families of children with behavioural challenges fort he last six months, scoring 5 points or more on the Conduct subscale of the Strengths and Difficulties Questionnaire (SDQ) and with some perceived problems by the parent in the impact section of the SDQ will be offered participation in a 2 arm trial. All data will be collected in Finland and stored at the University of Turku. All forms/scripts/ measures will be administered in Finnish or Swedish. This project has been approved by the Intermunicipal Hospital District of Southwest Finland. The Canadian team will provide expert and financial support. Treatment Group: Families randomized to Web-Enhanced Strongest Families (described above) will receive the website program described above. Control Group: Families randomized to Educational Control will receive access to a static website with parenting tips as well as a 45 coaching call to review the parenting tips. Randomization: (1:1 treatment: control; stratified by sex). Randomization sequences were generated by a qualified expert at arms length to the trial using a random permuted block sequence generator then concealed the placements using a double envelop system labeled with sequential numbers. Study staff were blinded to placements until randomization was completed by a study staff delegate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disruptive Behavior Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
464 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care control (Parenting tips)
Arm Type
No Intervention
Arm Description
Participants randomized to usual care will have access to a brief information website containing brief parenting tips but will not receive Strongest Families Intervention
Arm Title
Strongest Families
Arm Type
Experimental
Arm Description
Strongest Families intervention
Intervention Type
Behavioral
Intervention Name(s)
Strongest Families
Intervention Description
Behavioural intervention
Primary Outcome Measure Information:
Title
CHild Behaviour Checklist (to measure change from baseline)
Description
Measure of child behavioural change from baseline to 6 & 12 months
Time Frame
Measure change from baseline at 6 & 12 months
Secondary Outcome Measure Information:
Title
Depression Anxiety and Stress Scale Short Form (DASS-21)- Finnish
Description
Parental stress changes from baseline will be measured over time
Time Frame
Baseline, 6 & 12months
Title
The Parenting Scale (To measure change from baseline to 6 & 21 months)
Description
Measure parental parenting practice changes from baseline
Time Frame
To measure change from baseline to 6 & 12 months post randomization
Title
Barkley's Quick-Screen: The Barkley Adult ADHD Rating Scale IV (to measure change from baseline)
Description
To measure parental ADHD symptom changes form baseline
Time Frame
Measure change from baseline to 6&12 months
Title
Child Behaviour Checklist- Teacher version (to measure change since baseline)
Description
To measure child behaviour changes at daycare from baseline to 6 & 12 months post randomization
Time Frame
Measure change from Baseline to 6 & 12 months
Title
Satisfaction measure: Researcher designed for the Intervention group
Description
To measure satisfaction with Intervention and website information
Time Frame
end of program intervention (average is about 5 months but timing of completion varies between participants.)
Title
Strengths & Difficulties Questionnaire (Screening Tool)
Description
Screening tool used to identify high risk 4 year olds
Time Frame
Screening
Title
The Parent Problem Checklist
Description
To measure interparental conflict
Time Frame
Measure change from Baseline to 6 & 12 months
Title
The Sense of Coherence Scale (SOC-13)
Description
To measure parent's sense of coherence (i.e., global view of the world, and individual environment as comprehensible, manageable and meaningful)
Time Frame
Measure change from Baseline to 6 & 12 months
Title
The Inventory of Callous-Unemotional Traits
Description
To measure child empathy
Time Frame
Measure change from Baseline to 6 & 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J McGrath, PhD
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Turku, Finland
City
TUrku
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate summary data would be made available but not individual data.
Citations:
PubMed Identifier
24139323
Citation
McGrath PJ, Sourander A, Lingley-Pottie P, Ristkari T, Cunningham C, Huttunen J, Filbert K, Aromaa M, Corkum P, Hinkka-Yli-Salomaki S, Kinnunen M, Lampi K, Penttinen A, Sinokki A, Unruh A, Vuorio J, Watters C. Remote population-based intervention for disruptive behavior at age four: study protocol for a randomized trial of Internet-assisted parent training (Strongest Families Finland-Canada). BMC Public Health. 2013 Oct 21;13:985. doi: 10.1186/1471-2458-13-985.
Results Reference
background
PubMed Identifier
26913614
Citation
Sourander A, McGrath PJ, Ristkari T, Cunningham C, Huttunen J, Lingley-Pottie P, Hinkka-Yli-Salomaki S, Kinnunen M, Vuorio J, Sinokki A, Fossum S, Unruh A. Internet-Assisted Parent Training Intervention for Disruptive Behavior in 4-Year-Old Children: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Apr;73(4):378-87. doi: 10.1001/jamapsychiatry.2015.3411.
Results Reference
result
PubMed Identifier
35377332
Citation
Sourander A, Ristkari T, Kurki M, Gilbert S, Hinkka-Yli-Salomaki S, Kinnunen M, Pulkki-Raback L, McGrath PJ. Effectiveness of an Internet-Based and Telephone-Assisted Training for Parents of 4-Year-Old Children With Disruptive Behavior: Implementation Research. J Med Internet Res. 2022 Apr 4;24(4):e27900. doi: 10.2196/27900.
Results Reference
derived
PubMed Identifier
30196869
Citation
Sourander A, McGrath PJ, Ristkari T, Cunningham C, Huttunen J, Hinkka-Yli-Salomaki S, Kurki M, Lingley-Pottie P. Two-Year Follow-Up of Internet and Telephone Assisted Parent Training for Disruptive Behavior at Age 4. J Am Acad Child Adolesc Psychiatry. 2018 Sep;57(9):658-668.e1. doi: 10.1016/j.jaac.2018.07.001. Epub 2018 Aug 3.
Results Reference
derived

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

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