Disruptive Behavior DisorderPhase 1/2Fin-CanNCT01750996
Strongest Families Finland Canada: Family-based Prevention and Treatment Program of Early Childhood Disruptive Behavior
A Phase 1/2 study testing Strongest Families in people with Disruptive Behavior Disorder, run by IWK Health Centre at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Disruptive Behavior Disorder
- What is being tested?
- Strongest Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2011to Mar 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- - 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Disruptive Behavior Disorder
- Being tested
- Strongest Families
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strongest FamiliesBehavioural
Behavioural intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Strongest Families |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHild Behaviour Checklist (to measure change from baseline)
Measure of child behavioural change from baseline to 6 \& 12 months
Measured: Measure change from baseline at 6 & 12 months
Secondary outcomes (9)
Depression Anxiety and Stress Scale Short Form (DASS-21)- Finnish
Parental stress changes from baseline will be measured over time
Measured: Baseline, 6 & 12months
The Parenting Scale (To measure change from baseline to 6 & 21 months)
Measure parental parenting practice changes from baseline
Measured: 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)
To measure parental ADHD symptom changes form baseline
Measured: Measure change from baseline to 6&12 months
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
Measured: Measure change from Baseline to 6 & 12 months
Satisfaction measure: Researcher designed for the Intervention group
To measure satisfaction with Intervention and website information
Measured: end of program intervention (average is about 5 months but timing of completion varies between participants.)
Strengths & Difficulties Questionnaire (Screening Tool)
Screening tool used to identify high risk 4 year olds
Measured: Screening
The Parent Problem Checklist
To measure interparental conflict
Measured: Measure change from Baseline to 6 & 12 months
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)
Measured: Measure change from Baseline to 6 & 12 months
The Inventory of Callous-Unemotional Traits
To measure child empathy
Measured: Measure change from Baseline to 6 & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startOct 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Disruptive Behavior DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Patrick J McGrath, PhD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750996
- Sponsor's protocol ID
- CIHR# 103146
- Acronym
- Fin-Can
- Status last verified
- Sep 2016
- First submitted
- 14 Nov 2011
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Aggregate summary data would be made available but not individual data.
Publications
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.
PubMed 24139323Sourander 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.
PubMed 26913614Rissanen 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.
PubMed 39290059Sourander 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.
PubMed 35377332Sourander 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.
PubMed 30196869
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strongest Families Finland Canada: Family-based Prevention and Treatment Program of Early Childhood Disruptive Behavior
- ClinicalTrials.gov ID
- NCT01750996
- Acronym / sponsor ID
- Fin-Can / CIHR# 103146
- Conditions
- Disruptive Behavior Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Strongest FamiliesStrongest Families intervention |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- - Has received or is receiving behavioral treatment (parent training) before
- Diagnosis of:
- Child is not speaking using a sentence
- Child is deaf or blind
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strongest FamiliesBehavioural intervention | Behavioural | Strongest Families |
Primary outcome
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
9 secondary outcomes
Depression Anxiety and Stress Scale Short Form (DASS-21)- Finnish
Time frame: Baseline, 6 & 12months
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
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
Child Behaviour Checklist- Teacher version (to measure change since baseline)
Time frame: Measure change from Baseline to 6 & 12 months
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.)
Strengths & Difficulties Questionnaire (Screening Tool)
Time frame: Screening
The Parent Problem Checklist
Time frame: Measure change from Baseline to 6 & 12 months
The Sense of Coherence Scale (SOC-13)
Time frame: Measure change from Baseline to 6 & 12 months
The Inventory of Callous-Unemotional Traits
Time frame: Measure change from Baseline to 6 & 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Background: PubMed 24139323McGrath 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 publication: PubMed 26913614Sourander 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.
- Derived from this study: PubMed 39290059Rissanen 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.
- Derived from this study: PubMed 35377332Sourander 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.
- Derived from this study: PubMed 30196869Sourander 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.
- Individual participant dataSharing planned: No. Aggregate summary data would be made available but not individual data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J McGrath, PhD principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Strongest Families in people with Disruptive Behavior Disorder, run by IWK Health Centre at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CHild Behaviour Checklist (to measure change from baseline) (time frame: Measure change from baseline at 6 & 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01750996, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.