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ELECTRONIC ARTICLE |
* Christchurch Health and Development Study, Christchurch School of Medicine and Health Sciences, Christchurch, New Zealand
Early Start Service, Christchurch, New Zealand
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONREFERENCES |
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Methods. The study used a randomized, controlled trial design in which 220 families who were participating in the Early Start program were contrasted with a control series of 223 families who were not participating in the program. Families were enrolled in the program after population screening that was conducted by community health nurses. Families were enrolled in the program for up to 36 months. Outcomes were assessed at 6, 12, 24, and 36 months after trial entry.
Results. Families in the Early Start series received a mean of 24 months of service. Comparisons between the Early Start and control series over the 36-month follow-up period revealed that families in the Early Start program showed significant benefits in the areas of improved utilization of child health services, reduced rates of hospital attendance for injury/poisoning, increased preschool education, increased positive and nonpunitive parenting, reduced rates of severe parent/child assaults, and reduced rates of early problem behaviors. Effect sizes (Cohen's "d") were found to be in the small to moderate range, with d ranging from .03 to .31 (median: .22).
Conclusions. The Early Start program was associated with small to moderate benefits in a wide range of areas relating to child health, preschool education, parenting, child abuse, and early behavioral adjustment. Comparisons with other studies are made, and threats to validity are considered.
Key Words: home visitation • randomized controlled trial • child abuse • child health
Abbreviations: FSW, family support worker
In all developed societies, there have been growing concerns about issues relating to the health and psychosocial well-being of children and young people. These issues have spanned such matters as child health, child abuse, conduct difficulties, substance use, crime, teen pregnancy, and teen suicide. All of these outcomes are linked by the theme that they are more frequent among children and young people who have been exposed to adverse childhood and environments characterized by multiple social, educational, economic, and related disadvantages.1–3
In response to these concerns, there has been a growing investment in programs aimed at reducing the exposure of children and young people to such adversity. One approach that has been advocated is the use of methods of intensive home visitation.4–6 Typically, these programs are of lengthy duration and seek to assist families to achieve positive health and parenting goals. Although there has been a widespread support and advocacy for home visitation programs,7 rigorous evaluations of these programs using randomized trials have often failed to demonstrate benefits.8–12 For example, in a recent review of randomized trials of home visitation, Gomby et al13 concluded that "none found significant effects on all or even a majority of the measures employed, and many revealed no positive effects at all" (p 12). Despite the generally gloomy findings in this area, there is evidence that well-designed home visitation programs may be beneficial.
The most compelling evidence in this area comes from the work of Olds and colleagues6,14 in developing the Nurse Family Partnership program (formerly the Nurse Home Visitation Program). Evaluations of this program have shown both long- and short-term benefits. However, evaluations of a number of alternative models, including Hawaii Healthy Start,15,16, Healthy Families America,11 Parents as Teachers,12 the Comprehensive Child Development Program,10 and the Home Instruction Program for Preschool Youngsters,17 have shown no benefits or small and inconsistent benefits.13
In this article, we report the results of a randomized trial of a New Zealand–based family support service (Early Start). This service was founded in the mid-1990s by a consortium of researchers, health professionals, service providers, and community representatives who were concerned about a range of issues relating to child health and well-being. To address these issues, the consortium set up a home visitation service targeted at families who are facing stress and difficulty. The broad aims of this service were to provide families with sources of assistance, support, empowerment, and advice to address issues relating to health, parenting, and related matters during the preschool years. An important feature of this process of program development was that research evaluation was built into each stage of program development. This article describes the conduct of the randomized trial and examines the extent to which those in the Early Start series showed improved outcomes in the areas of child health, preschool education, utilization of welfare services, parenting, child abuse and neglect, and early behavioral adjustment.
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METHODS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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Client Recruitment
Clients for the trial were recruited using a population-based screening procedure. In this procedure, Plunket community nurses in the Christchurch 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 in which 2 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 
95% of families who give birth to a child. During the 19-month recruitment period (January 1, 2000, to July 31, 2001), Plunket nurses saw 4523 families; 588 of these families were eligible for the trial. Of those who were eligible for the trial, 443 (75%) agreed to participate in the study. In all cases, signed consent was obtained at the point of study referral.
Randomization
At the point of referral to the trial, families were randomly assigned to either Early Start or control series using a computer-generated sequence of random numbers. Of the 443 families who were referred to the trial, 220 entered the Early Start series and 223 entered the control series. Families in the Early Start series were contacted and invited to participate in the service. Of those who were invited to participate, 206 (96%) agreed to enter the service and 14 declined further participation in the trial. Of those in the control series, 221 (99%) agreed to participate in the trial. Those in the control series were paid an honorarium of (New Zealand) $50 per interview.
Service Delivery
Early Start uses a social learning model approach to home visitation. The critical elements of this model include (1) assessment of family needs, issues, challenges, strengths, and resources; (2) development of a positive partnership between the family support worker and client; (3) collaborative problem solving to devise solutions to family challenges; (4) the provision of support, mentoring, and advice to assist client families to mobilize their strengths and resources; and (5) involvement with the family throughout the child's preschool years. This model aims to strike a balance between deficits-based approaches that focus solely on family limitations and an exclusively strengths-based approach that may fail to attend to family deficits.
Initial Needs Assessment
All clients who were enrolled in Early Start were visited on a weekly basis during a 1-month period to conduct an in-depth assessment of family needs. At the end of this period, the level of family functioning was assessed using the Kempe Family Stress Checklist.18 Families who exceeded the cut point score of 25 were provided with the full Early Start service. Those who fell below this cut point were offered level 4 home visitation involving up to 2.5 hours of contact per 3 months. (Of the 220 families who were enrolled into the Early Start program, only 3.4% were offered level 4 home visitation).
Family Support Workers
Services were delivered by trained family support workers (FSWs) who visited families at home. All family support workers had nursing or social work qualifications and attended a 5-week training program. In New Zealand, the acquisition of social work or nursing qualifications requires passing a bachelor-level course at a relevant training institution. The decision to employ tertiary educated staff was based on the concerns of the Early Start Board to provide a professional level of service and also on emerging evidence suggesting improved outcomes for tertiary trained workers.19,20
Client Load
Each FSW had a client load of between 10 and 20 families, depending on levels of family need. The extent of family need was assessed using a level system that ranges from high need (level 1) to low need (level 4).
Service Goals
FSWs visited families to achieve a series of goals aimed at maximizing child and family health and well-being:
Service Delivery Principles
Although the program of home visitation was tailored to meet individual family need, the delivery of services was based on a number of common principles:
Research Assessments
Participants in the trial were assessed at baseline and at 6, 12, 24, and 36 months from trial enrollment.
1. Client interviews: at baseline and at 6, 12, 24, and 36 months, client families were assessed on a structured interview that was administered in the clients' homes by a trained survey interviewer. Interviews typically lasted between 45 and 60 minutes.
2. Medical record data: interview data were supplemented by general practitioner information on immunization and well-child visits and by hospital record data on attendances made by the child who was enrolled in the trial.
Medical Outcomes
A series of measures were used to assess the medical outcomes of the trial. These included (1) the number of visits made to the family doctor by 36 months, (2) whether the child was up to date with all immunizations at 36 months, (3) whether the child had received all well-child checks provided by the family doctor by 36 months, (4) rates of hospital attendance for accidents/injuries and accidental poisoning up to 36 months, and (5) whether the child was enrolled with preschool dental services or a dentist at 36 months. Information on immunizations, well-child checks, and injury/poisoning was obtained from medical records (after signed parental consent), and other measures were based on parental report.
Preschool Education and Welfare Utilization
To assess the extent to which families used nonmedical community services, 2 measures of service utilization were developed: (1) the duration of the child's attendance at preschool education services by 36 months and (2) the number of community service agency contacts that the family had made up to 36 months.
Parenting
At 36 months, parents were administered a 49-item parenting questionnaire that contained items derived from the Child Rearing Practices Report21 (J.H. Block, The Childrearing Practices Report: A Set of Q Items for the Description of Parental Socialization Attitudes and Values, unpublished manuscript, 1981) and the Adult-Adolescent Parenting Inventory.22,23 Factor analysis of this item set revealed that the test items measured 2 general factors:
For both dimensions, factor score estimates were constructed by summing the relevant test items. The resulting scales were of adequate reliability (positive parenting: 
= .89; nonpunitive parenting: = .77). A total parenting score was constructed by summing the positive parenting and nonpunitive parenting scales. All measures were scaled to a mean of 10 with an SD of 1.
Child Abuse and Neglect
Child abuse and neglect was assessed using 2 measures. The first was parental report of severe punishment of the child by either parent, based on the severe/very severe assault subscales of the Parent-Child Conflict Tactics Scale24 assessed at 12, 24, and 36 months. These subscales comprise 8 items that measure severe punitive behaviors (eg, "hit him/her with a fist or kicked him/her hard," "grabbed him/her around the neck and choked him/her"). Parents were classified as engaging in severe physical assault when they reported at least 1 item during the assessment period. The second was parental report of contact with the Child, Youth and Family Service for issues relating to child abuse and neglect.
Child Behavior
At 36 months, child behaviors were assessed using 50 items from the Infant Toddler Social and Emotional Assessment scale.25 These measures spanned a series of behavioral dimensions, which then were categorized into 2 overall scores.
A total score of behavioral adjustment was calculated by summing the externalizing and internalizing scores. Scale scores were of adequate reliability (internalizing: = .77; both externalizing and total score: = .92). All scores were scaled to a mean of 10 and an SD of 1.
Statistical Analyses
The results were analyzed using an "intention to treat" paradigm in which the results for the Early Start series were contrasted with results for the control series. The analysis of the trial used the following methods:
2 analysis. For mean scores, differences were tested using Student's t test for independent samples. For measuring effect sizes on a comparable basis, treatment differences for all comparisons were described using Cohen's "d."26 |
RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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ori (the indigenous people of New Zealand) parents was approximately twice that of the rate of Mori in the general New Zealand population.
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2 tests as applicable. The size of effect is described by the standardized difference (Cohen's "d") between means or proportions, and the association between treatment group and outcomes is described by the odds ratio for dichotomous outcomes and the correlation ratio (
) for continuous outcomes.
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Trial Dropout
As shown in Table 2, those in the Early Start group had a higher rate of trial dropout than those in the control series (16.4% vs 7.2%; P < .01). This higher rate of dropout arose largely from the fact that 14 of those who were assigned to the Early Start group declined to enter the trial after initial referral, compared with 2 families in the control group. To examine the extent to which dropout posed a threat to validity, we conducted the following analyses:
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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The findings of this evaluation of the Early Start program seem to show a similar range of benefits to those reported by Olds et al14 in their evaluation of the outcomes of the Elmira trial of the Nurse Family Partnership Program at 34 months follow-up. This similarity in the outcomes of Early Start and the Nurse Family Partnership Program raises interesting issues about the features that may distinguish these programs from less successful home visitation programs. Although there are substantial differences between Early Start and the Nurse Family Partnership Program in terms of client selection and service delivery, the programs share a number of common features that may have contributed to their success:
A feature of the results that merits comment concerns the size of effect. As we note, effect sizes were in the small to moderate range. This tendency for evaluations of home visitation programs to show small effects has been commented on in several reviews.13,30 We believe that there is a straightforward explanation for this finding. This explanation centers around 2 features of the randomized trial evaluation of home visitation that differ from the conditions that prevail in standard clinical trials. First, those who enter trials of home visitation are not a homogeneous population experiencing a common set of problems; rather, they are a heterogeneous group experiencing a wide range of issues and difficulties. Second, those who participate in trials of home visitation do not receive a standard method of treatment but rather a program of home visitation designed to meet their needs. Reflection on these features suggests that it would not be expected that a varying treatment applied to a heterogeneous population would produce large effects. However, what one would expect to find is that effective programs would show the pattern of small but pervasive benefits that are evident in this evaluation.
It is important to consider threats to validity in the trial. The first major threat to validity was that the trial design was an open trial in which both clients and research interviewers were aware of the treatment group to which the family was assigned. In part, this concern may be addressed by noting that the positive benefits for the trial were found using data from general practitioner record (immunization, well-child visits) and hospital records (accidents/injuries and accidental poisoning, child abuse and neglect). To the extent that data that were gathered from different sources all suggest benefits for Early Start, there are grounds for suggesting that the open nature of the trial was not a major threat to study validity.
The second major threat to study validity comes from variations in the delivery of the service, ranging from those who entered the trial but received no service to those who remained in the service for the full follow-up period. In this instance, we addressed this issue by using an intention-to-treat paradigm.
An additional threat to study validity comes from the higher dropout rate for the Early Start series. This arose largely because 14 families who were assigned to the Early Start program declined to enter the program after being randomly assigned, whereas only 2 families from the control series declined to enter the research. To examine the extent to which differential rates of sample attrition may have affected trial validity, we used 2 approaches. In the first approach, baseline data were used to compare the characteristics of the 184 Early Start families and 207 control families who were studied throughout the follow-up period. Despite extensive comparisons, there was no evidence of systematic differences between these groups, suggesting that losses to follow-up did not have an adverse effect on study randomization. In the second approach, missing data estimation methods were used to give complete data for all families. The results of this analysis produced similar conclusions to the analysis of the observed data, again supporting the view that sample loss did not threaten study validity.
A potential limitation of the study design was that only 75% of families who were screened as positive agreed to enter the trial. Although this does not affect the internal validity of the trial results, the extent to which findings may generalize to all families who are eligible for the program is unknown.
In recent years, there has been growing pessimism about the ability of home visitation programs to deliver effective outcomes for children and families.13,29. This pessimism comes from a growing number of randomized trials that have shown either no or inconsistent benefits. The present trial (along with the Nurse Family Partnership Program) seems to have been an exception to this trend. The success evident for Early Start and the Nurse Family Partnership Program suggests that it would be premature to conclude that home visitation is without benefit. At the same time, the growing number of studies showing little benefit for many programs suggests that it would be unwise to make large investments in implementing these programs on a society-wide basis.
In our view, what is required is an increased investment into research and development to understand more clearly the features that go into making programs successful and the features that mitigate against program success. The results of research to date suggest that although home visitation may have beneficial consequences for children and families, in many cases, seemingly well-designed programs fail to deliver their expected benefit. Finding out what makes programs work or fail is a matter of higher priority than the current practice of implementing home visitation programs on the basis of advocacy, hope, and the inconsistent evidence from current randomized trials.
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ACKNOWLEDGMENTS |
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We thank the large numbers of individuals and agencies that have contributed to the development and success of Early Start. These include past and present members of the Board of Early Start; the staff and management of Early Start; and the funding bodies who contributed to this project, including the Family Start Fund, Trust Bank Community Trust, the Christchurch City Council, the Canterbury District Health Board, the Child, Youth and Family Service, and the Ministry of Health. Finally, we owe a debt of gratitude to the 443 families who agreed to participate in this research.
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FOOTNOTES |
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Reprint requests to (D.F.) Christchurch Health & Development Study, Christchurch School of Medicine & Health Sciences, PO Box 4345, Christchurch, New Zealand. E-mail: david.fergusson{at}chmeds.ac.nz
Conflict of interest: Dr Fergusson is the Chairman of the Board of Early Start.
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REFERENCES |
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