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A pilot study to evaluate the efficacy of adding a structured home visiting intervention to improve outcomes for high-risk families attending the Incredible Years Parent Programme: study protocol for a randomised controlled trial.

ABSTRACT: BACKGROUND: Antisocial behaviour and adult criminality often have their origins in childhood and are best addressed early in the child's life using evidence-based treatments such as the 'Incredible Years Parent Programme'. However, families with additional risk factors who are at highest risk for poor outcomes do not always make sufficient change while attending such programmes. Additional support to address barriers and improve implementation of positive parenting strategies while these families attend the Incredible Years Programme may improve overall outcomes.The study aims to evaluate the efficacy of adding a structured home visiting intervention (Home Parent Support) to improve outcomes in families most at risk of poor treatment response from the Incredible Years intervention. This study will inform the design of a larger prospective randomised controlled trial. METHODS/DESIGN: A pilot single-blind, parallel, superiority, randomised controlled trial. Randomisation will be undertaken using a computer-generated sequence in a 1:1 ratio to the two treatments arranged in permuted blocks with stratification by age, sex, and ethnicity. One hundred and twenty six participants enrolled in the Incredible Years Parent Programme who meet the high-risk criteria will be randomly allocated to receive either Incredible Years Parent Programme and Home Parent Support, or the Incredible Years Parent Programme alone. The Home Parent Support is a 10-session structured home visiting intervention provided by a trained therapist, alongside the usual Incredible Years Parent Programme, to enhance the adoption of key parenting skills. The primary outcome is the change in child behaviour from baseline to post-intervention in parent reported Eyberg Child Behavior Inventory Problem Scale. DISCUSSION: This is the first formal evaluation of adding Home Parent Support alongside Incredible Years Parent Programme for families with risk factors who typically have poorer treatment outcomes. We anticipate that the intervention will help vulnerable families stay engaged, strengthen the adoption of effective parenting strategies, and improve outcomes for both the children and families. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612000878875.

SUBMITTER: Lees DG

PROVIDER: S-EPMC3938816 | biostudies-other | 2014

REPOSITORIES: biostudies-other

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A pilot study to evaluate the efficacy of adding a structured home visiting intervention to improve outcomes for high-risk families attending the Incredible Years Parent Programme: study protocol for a randomised controlled trial.

Lees Dianne G DG Fergusson David M DM Frampton Christopher M CM Merry Sally N SN

Trials 20140225

<h4>Background</h4>Antisocial behaviour and adult criminality often have their origins in childhood and are best addressed early in the child's life using evidence-based treatments such as the 'Incredible Years Parent Programme'. However, families with additional risk factors who are at highest risk for poor outcomes do not always make sufficient change while attending such programmes. Additional support to address barriers and improve implementation of positive parenting strategies while these ...[more]

PMID: 24568271

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Project description:ImportanceAntisocial behavior and adult criminality often have origins in childhood and are best addressed early in the child's life using evidence-based parenting programs. However, families with additional risk factors do not always make sufficient changes while attending such programs; these families may benefit from additional support.ObjectiveTo evaluate the efficacy of adding a 10-session, structured home parent support (HPS) intervention to enhance outcomes for high-risk families attending the Incredible Years Parent (IYP) program.Design, setting, and participantsA randomized clinical superiority trial of 126 parents of children aged 3 to 7 years with conduct problems compared the IYP program plus HPS with treatment as usual of the IYP program alone. Child behavior measures were collected before and after treatment and at the 6-month follow-up. Recruitment from 19 IYP groups began February 13, 2013, and follow-up data collection was completed June 4, 2015. All data were analyzed using an intention-to-treat design with last observation carried forward. Statistical analysis took place from May 20, 2015, to March 31, 2016.InterventionParents were randomly assigned to receive IYP program plus HPS or IYP alone.Main outcomes and measuresThe primary outcome measure was the posttreatment change in Eyberg Child Behavior Inventory Total Problem Scale (ECBI-P) score. Secondary outcomes included maintenance of change on the ECBI-P score, ECBI Intensity Scale score, and Social Competence Scale score at the 6-month follow-up; percentage of child behavior scores in the clinical range after treatment; retention; and attendance.ResultsA total of 126 parents (112 women and 14 men; mean [SD] age, 34.7 [8.4] years) were included; 63 parents were randomly assigned to each intervention group. Analysis of variance using intention to treat showed no significant difference between groups after treatment (P = .62). At follow-up, there was a medium effect (d = 0.63) showing a significant benefit from IYP plus HPS of 3.6 (95% CI, 0.8-6.5) on the ECBI-P score (F1,124 = 6.3; P = .01). Families receiving the IYP plus HPS intervention had significantly fewer children with child behavior scores in the clinical range after treatment (9 of 51 [17.6%]) compared with families receiving the IYP program alone (18 of 45 [40.0%]), and this status was maintained at follow-up. The HPS intervention had better retention than the IYP program (dropout, 7 [5.6%] vs 16 [12.7%]) as well as better attendance.Conclusions and relevanceIn this trial, the IYP plus HPS intervention significantly improved outcomes for the most vulnerable families at 6 months. This study demonstrated that the HPS intervention is an effective addition to the IYP program to improve engagement and implementation of IYP program strategies and enhance child behavior outcomes for the most vulnerable families.Trial registrationhttp://anzctr.org.au Identifier: ACTRN12612000878875.

Project description:BACKGROUND:Sugira Muryango is a father-engaged early child development and violence-prevention home-visiting programme delivered by trained lay workers. This cluster-randomised trial evaluates whether families living in extreme poverty (Ubudehe 1, the poorest category in the Government of Rwanda's wealth ranking) who receive Sugira Muryango in combination with a government-provided social protection programme demonstrate greater responsive, positive caregiving, nutrition, care seeking, hygiene, and father involvement compared with control families receiving usual care (UC). METHODS:Using detailed maps, we grouped closely spaced villages into 284 geographic clusters stratified by the type of social protection programmes operating in the village clusters; 198 clusters met all enrolment criteria. Sugira Muryango was delivered to n =?541 families in 100 treatment clusters with children aged 6-36?months living in extreme poverty. We assessed changes in outcomes in intervention and n =?508 UC control families using structured surveys and observation. Analyses were intent to treat using mixed models to accommodate clustering. RESULTS:Families receiving Sugira Muryango improved on core outcomes of parent-child relationships assessed using the Home Observation for Measurement of the Environment (Cohen's d =?0.87, 95% CI: 0.74, 0.99) and the Observation of Mother-Child Interaction (Cohen's d =?0.29, 95% CI: 0.17, 0.41). We also saw reductions in harsh discipline on items from the UNICEF MICS (OR?=?0.30: 95% CI: 0.19, 0.47) and in violent victimisation of female caregivers by their partners (OR?=?0.49, 95% CI: 0.24, 1.00) compared with UC. Moreover, children in families receiving SM had a 0.45 higher increase in food groups consumed in the past 24?h (Cohen's d =?0.35, 95% CI: 0.22, 0.47), increased care seeking for diarrhoea (OR?=?4.43, 95% CI: 1.95, 10.10) and fever (OR?=?3.28, 95% CI: 1.82, 5.89), and improved hygiene behaviours such as proper treatment of water (OR?=?3.39, 95% CI: 2.16, 5.30) compared with UC. Finally, Sugira Muryango was associated with decreased caregiver depression and anxiety (OR?=?0.58, 95% CI: 0.38, 0.88). CONCLUSIONS:Sugira Muryango led to improvements in caregiver behaviours linked to child development and health as well as reductions in violence. TRIAL REGISTRATION:ClinicalTrials.gov number NCT02510313.

Project description:Implementation fidelity is a key issue in home-visiting programs as it determines a program's effectiveness in accomplishing its original goals. This paper seeks to evaluate fidelity in a 27-month program addressing maternal and child health which took place in France between 2006 and 2011.To evaluate implementation fidelity, home visit case notes were analyzed using thematic qualitative and computer-assisted linguistic analyses.During the prenatal period, home visitors focused on the social components of the program. Visitors discussed the physical changes in pregnancy, and psychological and social environment issues. Discussing immigration, unstable employment and financial related issues, family relationships and dynamics and maternity services, while not expected, were found in case notes. Conversely, health during pregnancy, early child development and postpartum mood changes were not identified as topics within the prenatal case notes. During the postnatal period, most components of the intervention were addressed: home visitors observed the mother's adaptation to the baby; routine themes such as psychological needs and medical-social networks were evaluated; information on the importance of social support and on adapting the home environment was given; home visitors counseled on parental authority, and addressed mothers' self-esteem issues; finally, they helped to find child care, when necessary. Some themes were not addressed or partially addressed: health education, child development, home environment, mother's education plans and personal routine, partner support and play with the child. Other themes were not expected, but found in the case notes: social issues, mother-family relationship, relation with services, couple issues, quality of maternal behavior and child's language development.In this program, home visitors experienced difficulties addressing some of the objectives because they gave precedence to the families' urgent needs. This research stresses the importance of training home visitors to adapt the intervention to the social, psychological and health needs of families.

Project description:ObjectivesTo investigate the additional programme cost and cost-effectiveness of 'right@home' Nurse Home Visiting (NHV) programme in relation to improving maternal and child outcomes at child age 3 years compared with usual care.DesignA cost-utility analysis from a government-as-payer perspective alongside a randomised trial of NHV over 3-year period. Costs and quality-adjusted life-years (QALYs) were discounted at 5%. Analysis used an intention-to-treat approach with multiple imputation.SettingThe right@home was implemented from 2013 in Victoria and Tasmania states of Australia, as a primary care service for pregnant women, delivered until child age 2 years.Participants722 pregnant Australian women experiencing adversity received NHV (n=363) or usual care (clinic visits) (n=359).Primary and secondary outcome measuresFirst, a cost-consequences analysis to compare the additional costs of NHV over usual care, accounting for any reduced costs of service use, and impacts on all maternal and child outcomes assessed at 3 years. Second, cost-utility analysis from a government-as-payer perspective compared additional costs to maternal QALYs to express cost-effectiveness in terms of additional cost per additional QALY gained.ResultsWhen compared with usual care at child age 3 years, the right@home intervention cost $A7685 extra per woman (95% CI $A7006 to $A8364) and generated 0.01 more QALYs (95% CI -0.01 to 0.02). The probability of right@home being cost-effective by child age 3 years is less than 20%, at a willingness-to-pay threshold of $A50 000 per QALY.ConclusionsBenefits of NHV to parenting at 2 years and maternal health and well-being at 3 years translate into marginal maternal QALY gains. Like previous cost-effectiveness results for NHV programmes, right@home is not cost-effective at 3 years. Given the relatively high up-front costs of NHV, long-term follow-up is needed to assess the accrual of health and economic benefits over time.Trial registration numberISRCTN89962120.

Project description:BackgroundDespite the many advantages it offers, the percentage of dialysis patients that receive home dialysis [peritoneal dialysis (PD) or home haemodialysis (HHD)] in the Netherlands has declined over the last decade. Pre-dialysis education could stimulate the use of home dialysis. This article presents the results of the pre-dialysis programme GUIDE, with regard to the following question: Does the implementation of a structured pre-dialysis programme with a home-focused approach increase the number of pre-dialysis patients that choose and receive home dialysis?MethodsThe GUIDE process starts when a patient has an eGFR of 15 mL/min/1.73 m2. The process begins with a home visit from a case manager and the completion of questionnaires by the patient, the case manager and the nephrologist. A multidisciplinary meeting (MDM) is held to determine a specific patient profile (or treatment recommendation). This is followed by patient education, a second MDM and finally the selection of the treatment by the patient and the nephrologist. This retrospective observational study describes the selection process of all patients that received a treatment recommendation between 12 September 2013 and 18 December 2014 at Meander Medical Centre. Data were collected by file research and analysis of questionnaires.ResultsOne hundred and two patients were included. They started the process at a mean eGFR of 12.3 mL/min/1.73 m2. Home dialysis was recommended for 62.8% of the patients who were advised to have dialysis treatment. Of the patients that opted for dialysis, 34.2% chose PD and 8.2% chose HHD; 22.9% started home dialysis as their first therapy, compared with 17.6% in the months before implementation of GUIDE. Finally, 32.1% of the patients that received dialysis therapy received home dialysis. In the months before GUIDE, an average of just 19.5% of the patients that received dialysis received home dialysis.ConclusionsIn comparison to historical data, the pre-dialysis programme GUIDE increases the number of patients that choose and receive home dialysis.

Project description:IntroductionChild maltreatment involves acts of omission (neglect) or commission (abuse) often by caregivers that results in potential or actual harm to a child. The Building Blocks trial (ISRCTN23019866) assessed the short-term impact of an intensive programme of antenatal and postnatal visiting by specially trained nurses to support young pregnant women in England. The Building Blocks: 2-6 Study will assess the medium-term impacts of the programme for mothers and children (n=1562), through the linkage of routinely collected data to the trial data, with a particular emphasis on the programme's impact on preventing child maltreatment.Methods and analysisWe have developed a bespoke model of data linkage whereby outcome data for the trial cohort will be retrieved by linked anonymous data abstraction from NHS Digital, Office for National Statistics and the Department for Education's National Pupil Database. Participants will be given reasonable opportunity to opt out of this study prior to data transfer. The information centres will match participants to the information held in their databases using standard identifiers and send extracts to a third-party safe haven. The study will have 80% power to detect a 4% difference (4%vs8%) for the binary primary outcome of child in need status (from birth to key stage 1) at a two-sided 5% alpha level by following up 602 children in each trial arm. Analysis will be by intention to treat using logistic multilevel modelling. A cost-and-consequences analysis will extend the time frame of the economic analysis from the original trial.Ethics and disseminationThe study protocol has been approved by the National Health Service Wales Research Ethics Committee and the Health Research Authority's Confidentiality Advisory Group. Methods of innovative study design and findings will be disseminated through peer-reviewed journals and conferences; results will be of interest to clinical and policy stakeholders in the UK.Trial registration numberISRCTN23019866.

Dataset Information

A pilot study to evaluate the efficacy of adding a structured home visiting intervention to improve outcomes for high-risk families attending the Incredible Years Parent Programme: study protocol for a randomised controlled trial.

Publications

A pilot study to evaluate the efficacy of adding a structured home visiting intervention to improve outcomes for high-risk families attending the Incredible Years Parent Programme: study protocol for a randomised controlled trial.

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