Emotional ProblemsNCT02800603
A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems
A study testing Family Check Up in people with Emotional Problems and Behavior Problems, run by McMaster University at 1 site in Canada.
Trial summary
The purpose of the study is to evaluate the first Canadian implementation project of the Family Check up (FCU), an evidence-based prevention and early intervention model that engages families and communities in reducing the burden of childhood emotional and behaviour problems (EBP). Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Emotional Problems, Behavior Problems
- What is being tested?
- Family Check Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteCanada
- Study dates
- 18 Aug 2017to 30 Jun 2020
- Phase
- Interventional
- 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 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Custodial caregivers of a child aged 2 years, 0 months to 4 years, 11 months.
- Definition of "at-risk" for child EBP as measured by (a) OR (b):
- Elevated child EBP as indexed by above-population mean total scores on Strengths and Difficulties Questionnaire (SDQ), plus one of the following family or contextual risk factors
- Caregiver challenges: teen parent status, caregiver mental health problems (as indexed by K6 psychological distress scale), lone caregiver
- Sociodemographic risk factors (as indexed by the 2014 Ontario Child Health Study (OCHS) demographics questionnaire): family income below low-income cut-off (LICO), caregiver with less than grade 12 education, caregiver on social assistance.
- Families who score within norms on caregiver or sociodemographic risk AND child SDQ scores fall within the "high" range, indicating significant burden of EBP (and thus increased risk of persistent, severe problems over time).
- Caregivers with sufficient knowledge of English needed for assessment measures
- Caregivers capable of giving informed, written consent
Who cannot join
- Children with suspected severe to profound developmental delay
- Current enrolment in another clinical intervention trial
- Caregiver or child with a serious medical condition that, based on Investigator judgment, might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Making the Race Fair for Young Children at Risk": A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems
The purpose of the study is to evaluate the first Canadian implementation project of the Family Check up (FCU), an evidence-based prevention and early intervention model that engages families and communities in reducing the burden of childhood emotional and behaviour problems (EBP).
Read the detailed description
The aim of this study is to establish and evaluate the first Canadian implementation project of the FCU as an evidence-based prevention and early intervention model that engages families and communities in reducing the burden of childhood EBP. These objectives will be achieved in two foundational phases. During Phase 1, the clinical and systems infrastructure required to deliver, sustain and ultimately scale up the FCU will be built. During Phase 2, a 1:1 randomized controlled trial (RCT) will be conducted. The RCT will involve 280 participating caregiver-child dyads to examine the effects of the FCU as a targeted prevention intervention within the Canadian context, as delivered to caregivers and children aged 2-4 years at high risk of persistent childhood EBP.
Phase 1: Training, and Implementation: The REACH Institute at Arizona State University has developed an efficient model for international implementation of the FCU. They will help implement the intervention within McMaster Children's Hospital (MCH), train MCH therapists as FCU consultants, and two trainers. All therapists will be credentialed as FCU consultants by REACH through a process of supervision, consultation and monitoring of therapeutic fidelity.
Phase 2: Investigators will conduct a 1:1 randomized controlled trial of 280 children aged 2-4 years into either the FCU (n=140) or community control (CC, n=140). All 280 participants will undergo screening and a baseline FCU assessment before randomization. Once randomized, the FCU group will be provided with a feedback visit and up to 6 optional sessions of the Everyday Parenting (EDP) curriculum over 16 weeks. The CC group will receive general information about currently available community services in Hamilton. At 6 months, both groups will undergo light assessments. At 12 months both groups will repeat the baseline assessment, and the FCU group will have 1-2 FCU visits.
- Conditions
- Emotional Problems, Behavior Problems
- Being tested
- Family Check Up
- Keywords
- preschool mental health, emotional and behaviour problems
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Check UpBehavioural
The FCU is an ecologically sensitive, evidence-based, targeted intervention that aims to reduce child EBP. Features of the FCU: 1) Assessment-driven: a multi-method, multi-informant assessment in which the consultant reviews strengths and difficulties across domains of contextual risk, family functioning and child health. A tailored intervention plan is then created based on results 2) Motivational interviewing: Caregivers engage in self-assessment about motivation and barriers to addressing factors that may perpetuate risk. The consultant and caregiver work to establish a menu of services 3) The family may be offered up to 6 sessions of the "Everyday Parenting" curriculum. The FCU has demonstrated effectiveness and cultural sensitivity across multiple US settings.
| Study group | Role | What they receive |
|---|---|---|
| Family Check Up | Experimental | FCU Intervention: All 280 participants will undergo screening and a baseline FCU assessment before randomization. Once randomized, the FCU group (n=140) will be provided with a feedback visit and up to 6 optional sessions of the EDP curriculum over 16 weeks. Receives: Behavioral: Family Check Up |
| Community Control | No intervention | The Community Control group (n=140) will receive general information that includes a list of all the relevant services available in Hamilton. As such, the community control group would be provided with all the information needed to obtain standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome- Change in Child Externalizing Behaviors
Change in Child Behavior Checklist (CBCL) scores
Measured: Primary outcome will be measured at baseline, 6- and 12-months after enrollment
Secondary outcomes (4)
Secondary Outcome - Change in Parental Mental Health
The Kessler-6 (K6) will be used to measure change in psychological distress over time
Measured: This will be measured at baseline, 6- and 12-months
Secondary Outcome - Change in Parental Stress
Parenting Daily Hassles will be used to measure changes in parental stress over time
Measured: This will be measured at baseline and 12-months
Secondary Outcome - Change in Positive Parenting Practice
Positive parenting practice will be coded from videotaped parent-child interactions - outcome is change in positive parenting practice over time
Measured: This will be measured at baseline and 12-months
Secondary Outcome - Change in Child Compliance
The Coder Impressions Inventory (COIMP) will be used to score the child's behaviour from videotaped interactions - outcome is change in behaviour over time
Measured: This will be measured at baseline and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start18 Aug 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Emotional ProblemsStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Arizona State University, University of Calgary, Simon Fraser University
- Responsible party
- Sponsor
- Investigators
- Teresa Bennett, MD/PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800603
- Sponsor's protocol ID
- FCU
- Status last verified
- Aug 2020
- First submitted
- 3 Jun 2016
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Egger HL, Angold A. Common emotional and behavioral disorders in preschool children: presentation, nosology, and epidemiology. J Child Psychol Psychiatry. 2006 Mar-Apr;47(3-4):313-37. doi: 10.1111/j.1469-7610.2006.01618.x.
PubMed 16492262Cadman D, Boyle M, Szatmari P, Offord DR. Chronic illness, disability, and mental and social well-being: findings of the Ontario Child Health Study. Pediatrics. 1987 May;79(5):805-13.
PubMed 2952939Furniss T, Beyer T, Guggenmos J. Prevalence of behavioural and emotional problems among six-years-old preschool children: baseline results of a prospective longitudinal study. Soc Psychiatry Psychiatr Epidemiol. 2006 May;41(5):394-9. doi: 10.1007/s00127-006-0045-3. Epub 2006 Mar 25.
PubMed 16565920Skovgaard AM. Mental health problems and psychopathology in infancy and early childhood. An epidemiological study. Dan Med Bull. 2010 Oct;57(10):B4193.
PubMed 21040689Shonkoff JP, Richter L, van der Gaag J, Bhutta ZA. An integrated scientific framework for child survival and early childhood development. Pediatrics. 2012 Feb;129(2):e460-72. doi: 10.1542/peds.2011-0366. Epub 2012 Jan 4.
PubMed 22218840Bernier A, Carlson SM, Whipple N. From external regulation to self-regulation: early parenting precursors of young children's executive functioning. Child Dev. 2010 Jan-Feb;81(1):326-39. doi: 10.1111/j.1467-8624.2009.01397.x.
PubMed 20331670Gill AM, Hyde LW, Shaw DS, Dishion TJ, Wilson MN. The Family Check-Up in early childhood: a case study of intervention process and change. J Clin Child Adolesc Psychol. 2008 Oct;37(4):893-904. doi: 10.1080/15374410802359858.
PubMed 18991138Smith JD, Knoble NB, Zerr AA, Dishion TJ, Stormshak EA. Family check-up effects across diverse ethnic groups: reducing early-adolescence antisocial behavior by reducing family conflict. J Clin Child Adolesc Psychol. 2014;43(3):400-14. doi: 10.1080/15374416.2014.888670. Epub 2014 Apr 14.
PubMed 24731120Shaw DS, Dishion TJ, Supplee L, Gardner F, Arnds K. Randomized trial of a family-centered approach to the prevention of early conduct problems: 2-year effects of the family check-up in early childhood. J Consult Clin Psychol. 2006 Feb;74(1):1-9. doi: 10.1037/0022-006X.74.1.1.
PubMed 16551138Dishion TJ, Shaw D, Connell A, Gardner F, Weaver C, Wilson M. The family check-up with high-risk indigent families: preventing problem behavior by increasing parents' positive behavior support in early childhood. Child Dev. 2008 Sep-Oct;79(5):1395-414. doi: 10.1111/j.1467-8624.2008.01195.x.
PubMed 18826532Dishion TJ, Brennan LM, Shaw DS, McEachern AD, Wilson MN, Jo B. Prevention of problem behavior through annual family check-ups in early childhood: intervention effects from home to early elementary school. J Abnorm Child Psychol. 2014;42(3):343-54. doi: 10.1007/s10802-013-9768-2.
PubMed 24022677Connell A, Bullock BM, Dishion TJ, Shaw D, Wilson M, Gardner F. Family intervention effects on co-occurring early childhood behavioral and emotional problems: a latent transition analysis approach. J Abnorm Child Psychol. 2008 Nov;36(8):1211-25. doi: 10.1007/s10802-008-9244-6.
PubMed 18473160Lunkenheimer ES, Dishion TJ, Shaw DS, Connell AM, Gardner F, Wilson MN, Skuban EM. Collateral benefits of the Family Check-Up on early childhood school readiness: indirect effects of parents' positive behavior support. Dev Psychol. 2008 Nov;44(6):1737-52. doi: 10.1037/a0013858.
PubMed 18999335Weaver CM, Shaw DS, Crossan JL, Dishion TJ, Wilson MN. Parent-child conflict and early childhood adjustment in two-parent low-income families: parallel developmental processes. Child Psychiatry Hum Dev. 2015 Feb;46(1):94-107. doi: 10.1007/s10578-014-0455-5.
PubMed 24610382Brennan LM, Shelleby EC, Shaw DS, Gardner F, Dishion TJ, Wilson M. Indirect Effects of the Family Check-Up on School-Age Academic Achievement Through Improvements in Parenting in Early Childhood. J Educ Psychol. 2013 Aug 1;105(3):10.1037/a0032096. doi: 10.1037/a0032096.
PubMed 24319295
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Making the Race Fair for Young Children at Risk": A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems
- ClinicalTrials.gov ID
- NCT02800603
- Acronym / sponsor ID
- FCU
- Conditions
- Emotional Problems, Behavior Problems
- Keywords
- preschool mental health, emotional and behaviour problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Arizona State University, University of Calgary, Simon Fraser University
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 15 Jun 2016 (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 purpose of the study is to evaluate the first Canadian implementation project of the Family Check up (FCU), an evidence-based prevention and early intervention model that engages families and communities in reducing the burden of childhood emotional and behaviour problems (EBP).
Detailed description
The aim of this study is to establish and evaluate the first Canadian implementation project of the FCU as an evidence-based prevention and early intervention model that engages families and communities in reducing the burden of childhood EBP. These objectives will be achieved in two foundational phases. During Phase 1, the clinical and systems infrastructure required to deliver, sustain and ultimately scale up the FCU will be built. During Phase 2, a 1:1 randomized controlled trial (RCT) will be conducted. The RCT will involve 280 participating caregiver-child dyads to examine the effects of the FCU as a targeted prevention intervention within the Canadian context, as delivered to caregivers and children aged 2-4 years at high risk of persistent childhood EBP.
Phase 1: Training, and Implementation: The REACH Institute at Arizona State University has developed an efficient model for international implementation of the FCU. They will help implement the intervention within McMaster Children's Hospital (MCH), train MCH therapists as FCU consultants, and two trainers. All therapists will be credentialed as FCU consultants by REACH through a process of supervision, consultation and monitoring of therapeutic fidelity.
Phase 2: Investigators will conduct a 1:1 randomized controlled trial of 280 children aged 2-4 years into either the FCU (n=140) or community control (CC, n=140). All 280 participants will undergo screening and a baseline FCU assessment before randomization. Once randomized, the FCU group will be provided with a feedback visit and up to 6 optional sessions of the Everyday Parenting (EDP) curriculum over 16 weeks. The CC group will receive general information about currently available community services in Hamilton. At 6 months, both groups will undergo light assessments. At 12 months both groups will repeat the baseline assessment, and the FCU group will have 1-2 FCU visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Check Up | Experimental | Behavioral: Family Check UpFCU Intervention: All 280 participants will undergo screening and a baseline FCU assessment before randomization. Once randomized, the FCU group (n=140) will be provided with a feedback visit and up to 6 optional sessions of the EDP curriculum over 16 weeks. |
| Community Control | No intervention | –The Community Control group (n=140) will receive general information that includes a list of all the relevant services available in Hamilton. As such, the community control group would be provided with all the information needed to obtain standard care. |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Custodial caregivers of a child aged 2 years, 0 months to 4 years, 11 months.
- Definition of "at-risk" for child EBP as measured by (a) OR (b):
- Caregivers with sufficient knowledge of English needed for assessment measures
- Caregivers capable of giving informed, written consent
Key exclusion criteria (3 listed)
- Children with suspected severe to profound developmental delay
- Current enrolment in another clinical intervention trial
- Caregiver or child with a serious medical condition that, based on Investigator judgment, might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being
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 |
|---|---|---|
| Family Check UpThe FCU is an ecologically sensitive, evidence-based, targeted intervention that aims to reduce child EBP. Features of the FCU: 1) Assessment-driven: a multi-method, multi-informant assessment in which the consultant reviews strengths and difficulties across domains of contextual risk, family functioning and child health. A tailored intervention plan is then created based on results 2) Motivational interviewing: Caregivers engage in self-assessment about motivation and barriers to addressing factors that may perpetuate risk. The consultant and caregiver work to establish a menu of services 3) The family may be offered up to 6 sessions of the "Everyday Parenting" curriculum. The FCU has demonstrated effectiveness and cultural sensitivity across multiple US settings. | Behavioural | Family Check Up |
Primary outcome
Primary Outcome- Change in Child Externalizing Behaviors
Time frame: Primary outcome will be measured at baseline, 6- and 12-months after enrollment
Change in Child Behavior Checklist (CBCL) scores
4 secondary outcomes
Secondary Outcome - Change in Parental Mental Health
Time frame: This will be measured at baseline, 6- and 12-months
Secondary Outcome - Change in Parental Stress
Time frame: This will be measured at baseline and 12-months
Secondary Outcome - Change in Positive Parenting Practice
Time frame: This will be measured at baseline and 12-months
Secondary Outcome - Change in Child Compliance
Time frame: This will be measured at baseline and 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 2020.
- Background: PubMed 16492262Egger HL, Angold A. Common emotional and behavioral disorders in preschool children: presentation, nosology, and epidemiology. J Child Psychol Psychiatry. 2006 Mar-Apr;47(3-4):313-37. doi: 10.1111/j.1469-7610.2006.01618.x.
- Background: PubMed 2952939Cadman D, Boyle M, Szatmari P, Offord DR. Chronic illness, disability, and mental and social well-being: findings of the Ontario Child Health Study. Pediatrics. 1987 May;79(5):805-13.
- Background: PubMed 16565920Furniss T, Beyer T, Guggenmos J. Prevalence of behavioural and emotional problems among six-years-old preschool children: baseline results of a prospective longitudinal study. Soc Psychiatry Psychiatr Epidemiol. 2006 May;41(5):394-9. doi: 10.1007/s00127-006-0045-3. Epub 2006 Mar 25.
- Background: PubMed 21040689Skovgaard AM. Mental health problems and psychopathology in infancy and early childhood. An epidemiological study. Dan Med Bull. 2010 Oct;57(10):B4193.
- Background: PubMed 22218840Shonkoff JP, Richter L, van der Gaag J, Bhutta ZA. An integrated scientific framework for child survival and early childhood development. Pediatrics. 2012 Feb;129(2):e460-72. doi: 10.1542/peds.2011-0366. Epub 2012 Jan 4.
- Background: PubMed 20331670Bernier A, Carlson SM, Whipple N. From external regulation to self-regulation: early parenting precursors of young children's executive functioning. Child Dev. 2010 Jan-Feb;81(1):326-39. doi: 10.1111/j.1467-8624.2009.01397.x.
- Background: PubMed 18991138Gill AM, Hyde LW, Shaw DS, Dishion TJ, Wilson MN. The Family Check-Up in early childhood: a case study of intervention process and change. J Clin Child Adolesc Psychol. 2008 Oct;37(4):893-904. doi: 10.1080/15374410802359858.
- Background: PubMed 24731120Smith JD, Knoble NB, Zerr AA, Dishion TJ, Stormshak EA. Family check-up effects across diverse ethnic groups: reducing early-adolescence antisocial behavior by reducing family conflict. J Clin Child Adolesc Psychol. 2014;43(3):400-14. doi: 10.1080/15374416.2014.888670. Epub 2014 Apr 14.
- Background: PubMed 16551138Shaw DS, Dishion TJ, Supplee L, Gardner F, Arnds K. Randomized trial of a family-centered approach to the prevention of early conduct problems: 2-year effects of the family check-up in early childhood. J Consult Clin Psychol. 2006 Feb;74(1):1-9. doi: 10.1037/0022-006X.74.1.1.
- Background: PubMed 18826532Dishion TJ, Shaw D, Connell A, Gardner F, Weaver C, Wilson M. The family check-up with high-risk indigent families: preventing problem behavior by increasing parents' positive behavior support in early childhood. Child Dev. 2008 Sep-Oct;79(5):1395-414. doi: 10.1111/j.1467-8624.2008.01195.x.
- Background: PubMed 24022677Dishion TJ, Brennan LM, Shaw DS, McEachern AD, Wilson MN, Jo B. Prevention of problem behavior through annual family check-ups in early childhood: intervention effects from home to early elementary school. J Abnorm Child Psychol. 2014;42(3):343-54. doi: 10.1007/s10802-013-9768-2.
- Background: PubMed 18473160Connell A, Bullock BM, Dishion TJ, Shaw D, Wilson M, Gardner F. Family intervention effects on co-occurring early childhood behavioral and emotional problems: a latent transition analysis approach. J Abnorm Child Psychol. 2008 Nov;36(8):1211-25. doi: 10.1007/s10802-008-9244-6.
- Individual participant dataSharing planned: No
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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.
Teresa Bennett, MD/PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Check Up in people with Emotional Problems and Behavior Problems, run by McMaster University at 1 site in Canada.
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 8 inclusion and 3 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 2020. 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 Canada. 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.
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?
Primary Outcome- Change in Child Externalizing Behaviors (time frame: Primary outcome will be measured at baseline, 6- and 12-months after enrollment). 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 NCT02800603, which also lists 40 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 2020.