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

NCT01750996 | Completed Phase 1

• 1 other identifier: CIHR# 103146
• Study Type: interventional
• Target: 464
• Locations: 1 country
• Sites: 1

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.

Conditions

Disruptive Behavior Disorder

Outcome Measures

Primary Outcomes (1)

• CHild Behaviour Checklist (to measure change from baseline)

  Measure of child behavioural change from baseline to 6 \& 12 months

  Measure change from baseline at 6 & 12 months

Secondary Outcomes (9)

• Depression Anxiety and Stress Scale Short Form (DASS-21)- Finnish

  Baseline, 6 & 12months

• The Parenting Scale (To measure change from baseline to 6 & 21 months)

  To measure change from baseline to 6 & 12 months post randomization

• Barkley's Quick-Screen: The Barkley Adult ADHD Rating Scale IV (to measure change from baseline)

  Measure change from baseline to 6&12 months

• Child Behaviour Checklist- Teacher version (to measure change since baseline)

  Measure change from Baseline to 6 & 12 months

• Satisfaction measure: Researcher designed for the Intervention group

  end of program intervention (average is about 5 months but timing of completion varies between participants.)

Study Arms (2)

Usual Care control (Parenting tips)

NO INTERVENTION

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

EXPERIMENTAL

Strongest Families intervention

Behavioral: Strongest Families

Interventions

Strongest Families BEHAVIORAL

Behavioural intervention

Strongest Families

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• IWK Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Turku, Finland

Turku, Finland

Location

Related Publications (5)

• 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.

  PMID: 24139323 BACKGROUND

• 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.

  PMID: 26913614 RESULT

• Rissanen E, Kuvaja-Kollner V, Kankaanpaa E. Cost-Effectiveness of Digital Preventive Parent Training for Early Childhood Disruptive Behaviour. J Ment Health Policy Econ. 2024 Sep 1;27(3):85-98.

  PMID: 39290059 DERIVED

• 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.

  PMID: 35377332 DERIVED

• 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.

  PMID: 30196869 DERIVED

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Patrick J McGrath, PhD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: December 17, 2012
• Study Start: October 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 2, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)