Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000352606
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
9/09/2005
Date last updated
19/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early Start Field Trial
Scientific title
Outcome Evaluation of Early Start: The efficacy of home visitation as a mechanism to address issues relating to child rearing, parenting and family functioning amongst families with young children who are at risk for experiencing high levels of stress and difficulties in family functioning.
Secondary ID [1] 288366 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ESFT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
At-risk families with young children 446 0
Condition category
Condition code
Other 523 523 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Visitation programme designed to assist families with young children who are at risk for experiencing high levels of stress and difficulties in family functioning. Intensive family support is provided by trained Family Support Workers, all of whom have nursing, social work or similar qualifications. Family support may be provided for up to 5 years. The ESFT is a randomised controlled trial designed to evaluate the efficacy of the Early Start programme as a mechanism for bringing about positive change in areas relating to child rearing, parenting and family functioning. In this trial, a series of 443 children/families has been randomly allocated to receive either the intervention (Early Start, N=220) or no intervention (controls, N=223). All families will have access to the existing mix of social and family services currently available in the community. The ESFT will thus assess the value of Early Start as an adjunct to the existing mix of community services. Families were enrolled into the trial over a 19 month period from January 2000 to July 2001. Assessments have/will be conducted at baseline (enrolment), 6 months, 1 year, annual intervals up to 6 years, and at 9 years post enrolment. Follow-up assessments will utilise information from multiple sources including: parental interview; teacher report; psychometric testing of children; medical and other official record data.
Intervention code [1] 388 0
Prevention
Comparator / control treatment
No intervention
Control group
Active

Outcomes
Primary outcome [1] 591 0
Child morbidity
Timepoint [1] 591 0
Assessed 0 - 9 years post enrolment
Primary outcome [2] 592 0
Preventive health care utilisation
Timepoint [2] 592 0
Assessed 0 - 6 years post enrolment
Primary outcome [3] 593 0
Child safety and protection
Timepoint [3] 593 0
Assessed 0 - 9 years post enrolment
Primary outcome [4] 594 0
Utilisation of preschool education
Timepoint [4] 594 0
Assessed 0 - 6 years post enrolment
Primary outcome [5] 595 0
Child abuse
Timepoint [5] 595 0
Assessed 0 - 9 years post enrolment
Primary outcome [6] 596 0
Parenting
Timepoint [6] 596 0
Assessed 0 - 9 years post enrolment
Primary outcome [7] 597 0
Child behaviour
Timepoint [7] 597 0
Assessed 0 - 9 years post enrolment
Primary outcome [8] 598 0
School readiness/adjustment
Timepoint [8] 598 0
Assessed at 5 and 6 years post enrolment
Secondary outcome [1] 1258 0
Parental mental health
Timepoint [1] 1258 0
Assessed 0 - 9 years post enrolment
Secondary outcome [2] 1259 0
Substance use
Timepoint [2] 1259 0
Assessed 0 - 9 years post enrolment
Secondary outcome [3] 1260 0
Partner relationships and family violence
Timepoint [3] 1260 0
Assessed 0 - 9 years post enrolment
Secondary outcome [4] 1261 0
Family planning
Timepoint [4] 1261 0
Assessed 0 - 9 years post enrolment
Secondary outcome [5] 1262 0
Family economic functioning
Timepoint [5] 1262 0
Assessed 0 - 9 years post enrolment
Secondary outcome [6] 1263 0
Social service utilisation
Timepoint [6] 1263 0
Assessed 0 - 9 years post enrolment

Eligibility
Key inclusion criteria
Participant families were recruited using a population based screening procedure. In this procedure, Plunket community nurses in the Christchurch (New Zealand) urban region screened all new clients using an 11 point screening measure based on the measure used in the Hawaii Healthy Start Program. This screening measure covered a series of areas of parent and family functioning including: age of parents; social support; planning of pregnancy; parental substance use; family financial situation; and family violence. Plunket Nurses were asked to refer any family where two or more risk factors were present. In addition, Plunket Nurses were asked to refer any family in which there were serious concerns about the family's capacity to care for the child. Plunket nurses are community nurses who visit families within 3 months of the birth of a child to provide health and parenting support. The service is free, and within Christchurch, Plunket nurses see approximately 95% of families giving birth to a child. All referrals were on the basis of signed parental consent.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were allocated to either the Early Start or control series based strictly on the order in which referrals were received from Plunket. Allocation was determined by a pre-specified sequence of random numbers. This sequence was known at the outset of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated sequence of random numbers from a uniform [0,1] distribution. Numbers below .5 were assigned to the Early Start series and otherwise to the control series.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2000
Actual
4/02/2000
Date of last participant enrolment
Anticipated
Actual
20/09/2001
Date of last data collection
Anticipated
Actual
Sample size
Target
440
Accrual to date
Final
443
Recruitment outside Australia
Country [1] 177 0
New Zealand
State/province [1] 177 0
Christchurch, Canterbury

Funding & Sponsors
Funding source category [1] 581 0
Government body
Name [1] 581 0
Health Research Council of New Zealand (research evaluation)
Country [1] 581 0
New Zealand
Funding source category [2] 582 0
Government body
Name [2] 582 0
NZ Government (Early Start service provision)
Country [2] 582 0
New Zealand
Primary sponsor type
University
Name
Christchurch Health and Development Study
Address
University of Otago, Christchurch, PO Box 4345, Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 471 0
University
Name [1] 471 0
University of Otago
Address [1] 471 0
PO Box 56, Dunedin 9054
Country [1] 471 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1603 0
Canterbury Ethics Committee
Ethics committee address [1] 1603 0
Ethics committee country [1] 1603 0
New Zealand
Date submitted for ethics approval [1] 1603 0
06/05/1999
Approval date [1] 1603 0
30/06/1999
Ethics approval number [1] 1603 0
CTY/99/06/069
Ethics committee name [2] 294204 0
Canterbury Ethics Committee
Ethics committee address [2] 294204 0
Ethics committee country [2] 294204 0
New Zealand
Date submitted for ethics approval [2] 294204 0
01/09/2001
Approval date [2] 294204 0
09/10/2001
Ethics approval number [2] 294204 0
CTY/01/09/118
Ethics committee name [3] 294205 0
Canterbury Ethics Committee
Ethics committee address [3] 294205 0
Ethics committee country [3] 294205 0
New Zealand
Date submitted for ethics approval [3] 294205 0
27/01/2004
Approval date [3] 294205 0
26/02/2004
Ethics approval number [3] 294205 0
CTR/04/02/020
Ethics committee name [4] 294206 0
Southern Health and Disability Ethics Committee
Ethics committee address [4] 294206 0
Ethics committee country [4] 294206 0
Date submitted for ethics approval [4] 294206 0
16/02/2009
Approval date [4] 294206 0
07/04/2009
Ethics approval number [4] 294206 0
URB/09/03/11

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36159 0
A/Prof John Horwood
Address 36159 0
Christchurch Health and Development Study, Department of Psychological Medicine, University of Otago, Christchurch, PO Box 4345, Christchurch 8140
Country 36159 0
New Zealand
Phone 36159 0
+64 3 3786441
Fax 36159 0
Email 36159 0
[email protected]
Contact person for public queries
Name 9577 0
John Horwood
Address 9577 0
Christchurch Health and Development Study, Department of Psychological Medicine, University of Otago, Christchurch, PO Box 4345, Christchurch 8140
Country 9577 0
New Zealand
Phone 9577 0
+64 3 3786441
Fax 9577 0
Email 9577 0
[email protected]
Contact person for scientific queries
Name 505 0
John Horwood
Address 505 0
Christchurch Health and Development Study, Department of Psychological Medicine, University of Otago, Christchurch, PO Box 4345, Christchurch 8140
Country 505 0
New Zealand
Phone 505 0
+64 3 3786441
Fax 505 0
Email 505 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.