Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-30 @ 6:22 AM
Study NCT ID:
NCT02800603
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2016-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2016-06-03', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory outcome - Health Service Utilization', 'timeFrame': 'This will be measured at baseline, 3-, 6-, 9- and 12- months.', 'description': 'Service utilization questionnaire'}, {'measure': 'Exploratory outcome - Change in Behavioural Observations of Parenting', 'timeFrame': 'This will be measured at baseline, 6-months and 12 months.', 'description': 'Behavioural Observations of Parenting will be assessed using videotapes of structured interaction between the child and parent'}, {'measure': 'Exploratory outcome - Change in Parental Emotional Regulation', 'timeFrame': 'Exploratory outcomes will be measured at baseline and at 12 months.', 'description': 'Difficulties in Emotion Regulation Scale (DERS)'}, {'measure': 'Exploratory outcome - Change in Child Emotional Regulation', 'timeFrame': 'This will be measured at baseline and at 12 months.', 'description': 'Child emotional regulation will be assessed using videotapes of the child performing structured tasks'}, {'measure': 'Exploratory outcome -Parent Executive Functioning', 'timeFrame': 'This will be measured at baseline.', 'description': 'Parent executive functioning will be assessed using observation of structured tasks'}, {'measure': 'Exploratory outcome - Change in Child Executive Functioning', 'timeFrame': 'This will be measured at baseline and at 12 months.', 'description': 'Child executive functioning will be assessed using observation of structured tasks'}, {'measure': 'Exploratory outcome - Change in Hair Cortisol', 'timeFrame': 'This will be measured at baseline, 6-months and 12 months.', 'description': 'Small amounts of hair will be collected from child and parents to assess hair cortisol'}], 'primaryOutcomes': [{'measure': 'Primary Outcome- Change in Child Externalizing Behaviors', 'timeFrame': 'Primary outcome will be measured at baseline, 6- and 12-months after enrollment', 'description': 'Change in Child Behavior Checklist (CBCL) scores'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome - Change in Parental Mental Health', 'timeFrame': 'This will be measured at baseline, 6- and 12-months', 'description': 'The Kessler-6 (K6) will be used to measure change in psychological distress over time'}, {'measure': 'Secondary Outcome - Change in Parental Stress', 'timeFrame': 'This will be measured at baseline and 12-months', 'description': 'Parenting Daily Hassles will be used to measure changes in parental stress over time'}, {'measure': 'Secondary Outcome - Change in Positive Parenting Practice', 'timeFrame': 'This will be measured at baseline and 12-months', 'description': 'Positive parenting practice will be coded from videotaped parent-child interactions - outcome is change in positive parenting practice over time'}, {'measure': 'Secondary Outcome - Change in Child Compliance', 'timeFrame': 'This will be measured at baseline and 12-months', 'description': "The Coder Impressions Inventory (COIMP) will be used to score the child's behaviour from videotaped interactions - outcome is change in behaviour over time"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preschool mental health', 'emotional and behaviour problems'], 'conditions': ['Emotional Problems', 'Behavior Problems']}, 'referencesModule': {'references': [{'pmid': '16492262', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '2952939', 'type': 'BACKGROUND', 'citation': 'Cadman 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.'}, {'pmid': '16565920', 'type': 'BACKGROUND', 'citation': 'Furniss 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.'}, {'pmid': '21040689', 'type': 'BACKGROUND', 'citation': 'Skovgaard AM. Mental health problems and psychopathology in infancy and early childhood. An epidemiological study. Dan Med Bull. 2010 Oct;57(10):B4193.'}, {'pmid': '22218840', 'type': 'BACKGROUND', 'citation': 'Shonkoff 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.'}, {'pmid': '20331670', 'type': 'BACKGROUND', 'citation': "Bernier 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."}, {'pmid': '18991138', 'type': 'BACKGROUND', 'citation': 'Gill AM, Hyde LW, Shaw DS, Dishion TJ, Wilson MN. The Family Check-Up in early childhood: a case study of intervention process and change. 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The trajectory of fidelity in a multiyear trial of the family check-up predicts change in child problem behavior. J Consult Clin Psychol. 2015 Oct;83(5):1006-11. doi: 10.1037/ccp0000034. Epub 2015 Jun 29.'}, {'pmid': '3632257', 'type': 'BACKGROUND', 'citation': 'Boyle MH, Offord DR, Hofmann HG, Catlin GP, Byles JA, Cadman DT, Crawford JW, Links PS, Rae-Grant NI, Szatmari P. Ontario Child Health Study. I. Methodology. Arch Gen Psychiatry. 1987 Sep;44(9):826-31. doi: 10.1001/archpsyc.1987.01800210078012.'}, {'type': 'BACKGROUND', 'citation': 'Radloff, L. S. The CES-D scale: A self-report depression scale for research in the general population. Applied psychological measurement 1(3): 385-401, 1977.'}, {'type': 'BACKGROUND', 'citation': 'Eaton WW, Muntaner C, Smith C, Tien A, Ybarra M. The Use of Psychological Testing for Treatment Planning and Outcomes Assessment, Volume 3: Instruments for Adults, 3rd ed. Mahwah, NJ: Lawrence Erlbaum; 2004. Chapter 11, Center for Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R); p 363-377.'}, {'type': 'BACKGROUND', 'citation': 'Gratz, K.L., & Roemer, L. Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment 26(1): 41-54, 2004.'}, {'pmid': '39572487', 'type': 'DERIVED', 'citation': 'Bennett T, Georgiades K, Gonzalez A, Janus M, Lipman E, Pires P, Prime H, Duku E, Jambon M, McLennan JD, Gross J; Making the Race Fair Study Team. Targeted Child Mental Health Prevention and Parenting Support Within a Canadian Context: A Randomized Controlled Trial Evaluating the U.S.-Developed Family Check-Up(R). Prev Sci. 2025 May;26(4):555-567. doi: 10.1007/s11121-024-01741-3. Epub 2024 Nov 22.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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.\n\nPhase 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.\n\nPhase 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Screening eligibility criteria include:\n\n1. Custodial caregivers of a child aged 2 years, 0 months to 4 years, 11 months.\n2. Definition of "at-risk" for child EBP as measured by (a) OR (b):\n\n * 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\n\n * Caregiver challenges: teen parent status, caregiver mental health problems (as indexed by K6 psychological distress scale), lone caregiver\n * 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.\n * 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).\n3. Caregivers with sufficient knowledge of English needed for assessment measures\n4. Caregivers capable of giving informed, written consent\n\nExclusion Criteria:\n\n1. Children with suspected severe to profound developmental delay\n2. Current enrolment in another clinical intervention trial\n3. 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'}, 'identificationModule': {'nctId': 'NCT02800603', 'briefTitle': 'A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': '"Making the Race Fair for Young Children at Risk": A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems', 'orgStudyIdInfo': {'id': 'FCU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Family Check Up', 'description': '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.', 'interventionNames': ['Behavioral: Family Check Up']}, {'type': 'NO_INTERVENTION', 'label': 'Community Control', 'description': '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.'}], 'interventions': [{'name': 'Family Check Up', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Family Check Up']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S 4L8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Teresa Bennett, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, {'name': 'Arizona State University', 'class': 'OTHER'}, {'name': 'University of Calgary', 'class': 'OTHER'}, {'name': 'Simon Fraser University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}