Randomised controlled trial evaluating the effectiveness and cost-effectiveness of 'Families for Health', a family-based childhood obesity treatment intervention delivered in a community setting for ages 6 to 11 years.

BACKGROUND: Effective programmes to help children manage their weight are required. 'Families for Health' focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health version 1 showed sustained reductions in mean body mass index (BMI) z-score after 2 years in a pilot project. OBJECTIVE: The aim was to evaluate its effectiveness and cost-effectiveness in a randomised controlled trial (RCT). DESIGN: The trial was a multicentre, investigator-blind RCT, with a parallel economic and process evaluation, with follow-up at 3 and 12 months. Randomisation was by family unit, using a 1 : 1 allocation by telephone registration, stratified by three sites, with a target of 120 families. SETTING: Three sites in the West Midlands, England, UK. PARTICIPANTS: Children aged 6-11 years who were overweight (≥ 91st centile BMI) or obese (≥ 98th centile BMI), and their parents/carers. Recruitment was via referral or self-referral. INTERVENTIONS: Families for Health version 2 is a 10-week, family-based community programme with parallel groups for parents and children, addressing parenting, lifestyle, social and emotional development. Usual care was the treatment for childhood obesity provided within each locality. MAIN OUTCOME MEASURES: Joint primary outcome measures were change in children's BMI z-score and incremental cost per quality-adjusted life-year (QALY) gained at 12 months' follow-up (QALYs were calculated using the European Quality of Life-5 Dimensions Youth version). Secondary outcome measures included changes in children's waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. Parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style were also assessed. The process evaluation documented recruitment, reach, dose delivered, dose received and fidelity, using mixed methods. RESULTS: The study recruited 115 families (128 children; 63 boys and 65 girls), with 56 families randomised to the Families for Health arm and 59 to the 'usual-care' control arm. There was 80% retention of families at 3 months (Families for Health, 46 families; usual care, 46 families) and 72% retention at 12 months (Families for Health, 44 families; usual care, 39 families). The change in BMI z-score at 12 months was not significantly different in the Families for Health arm and the usual-care arm [0.114, 95% confidence interval (CI) -0.001 to 0.229; p = 0.053]. However, within-group analysis showed that the BMI z-score was significantly reduced in the usual-care arm (-0.118, 95% CI -0.203 to -0.034; p = 0.007), but not in the Families for Health arm (-0.005, 95% CI -0.085 to 0.078; p = 0.907). There was only one significant difference between groups for secondary outcomes. The economic evaluation, taking a NHS and Personal Social Services perspective, showed that mean costs 12 months post randomisation were significantly higher for Families for Health than for usual care (£998 vs. £548; p < 0.001). The mean incremental cost-effectiveness of Families for Health was estimated at £552,175 per QALY gained. The probability that the Families for Health programme is cost-effective did not exceed 40% across a range of thresholds. The process evaluation demonstrated that the programme was implemented, as planned, to the intended population and any adjustments did not deviate widely from the handbook. Many families waited more than 3 months to receive the intervention. Facilitators', parents' and children's experiences of Families for Health were largely positive and there were no adverse events. Further analysis could explore why some children show a clinically significant benefit while others have a worse outcome. CONCLUSIONS: Families for Health was neither effective nor cost-effective for the management of obesity in children aged 6-11 years, in comparison with usual care. Further exploration of the wide range of responses in BMI z-score in children following the Families for Health and usual-care interventions is warranted, focusing on children who had a clinically significant benefit and those who showed a worse outcome with treatment. Further research could focus on the role of parents in the prevention of obesity, rather than treatment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN45032201. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 1. See the NIHR Journals Library website for further project information.

Transitioning care-leavers with mental health needs: 'they set you up to fail!'

BACKGROUND: Children in the UK care system often face multiple disadvantages in terms of health, education and future employment. This is especially true of mental health where they present with greater mental health needs than other children. Although transition from care - the process of leaving the local authority as a child-in-care to independence - is a key juncture for young people, it is often experienced negatively with inconsistency in care and exacerbation of existing mental illness. Those receiving support from child and adolescent mental health services (CAMHS), often experience an additional, concurrent transfer to adult services (AMHS), which are guided by different service models which can create a care gap between services. METHOD: This qualitative study explored care-leavers' experiences of mental illness, and transition in social care and mental health services. Twelve care-leavers with mental health needs were interviewed and data analysed using framework analysis. RESULTS: Sixteen individual themes were grouped into four superordinate themes: overarching attitudes towards the care journey, experience of social care, experience of mental health services and recommendations. CONCLUSIONS: Existing social care and mental health teams can improve the care of care-leavers navigating multiple personal, practical and service transitions. Recommendations include effective Pathway Planning, multiagency coordination, and stating who is responsible for mental health care and its coordination. Participants asked that youth mental health services span the social care transition; and provide continuity of mental health provision when care-leavers are at risk of feeling abandoned and isolated, suffering deteriorating mental health and struggling to establish new relationships with professionals. Young people say that the key to successful transition and achieving independence is maintaining trust and support from services.

Randomised controlled trial and economic evaluation of the 'Families for Health' programme to reduce obesity in children.

OBJECTIVE: Evaluating effectiveness and cost-effectiveness of 'Families for Health V2' (FFH) compared with usual care (UC). DESIGN: Multicentre randomised controlled trial (RCT) (investigators blinded, families unblinded) and economic evaluation. Stratified randomisation by family; target of 120 families. SETTING: Three National Health Service Primary Care Trusts in West Midlands, England. PARTICIPANTS: Overweight or obese (≥91st or ≥98th centile body mass index (BMI)) children aged 6-11 years and their parents/carers, recruited March 2012-February 2014. INTERVENTIONS: FFH; a 10-week community-based family programme addressing parenting, lifestyle change and social and emotional development. UC; usual support for childhood obesity at each site. MAIN OUTCOME MEASURES: Primary outcomes were 12-months change in children's BMI z-score and incremental cost per quality-adjusted life-year gained (QALY). Secondary outcomes included changes in children's physical activity, fruit and vegetable consumption and quality of life, parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style. RESULTS: 115 families (128 children) were randomised to FFH (n=56) or UC (n=59). There was no significant difference in BMI z-score 12-months change (0.114, 95% CI -0.001 to 0.229, p=0.053; p=0.026 in favour of UC with missing value multiple imputation). One secondary outcome, change in children's waist z-score, was significantly different between groups in favour of UC (0.15, 95% CI 0.00 to 0.29). Economic evaluation showed that mean costs were significantly higher for FFH than UC (£998 vs £548, p<0.001). Mean incremental cost-effectiveness of FFH was estimated at £552 175 per QALY. CONCLUSIONS: FFH was neither effective nor cost-effective for the management of obesity compared with UC. TRIAL REGISTRATION NUMBER: ISRCTN45032201.

Evaluation of the effectiveness and cost-effectiveness of Families for Health V2 for the treatment of childhood obesity: study protocol for a randomized controlled trial.

BACKGROUND: Effective programs to help children manage their weight are required. Families for Health focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health V1 showed sustained reductions in overweight after 2 years in a pilot evaluation, but lacks a randomized controlled trial (RCT) evidence base. METHODS/DESIGN: This is a multi-center, investigator-blind RCT, with parallel economic evaluation, with a 12-month follow-up. The trial will recruit 120 families with at least one child aged 6 to 11 years who is overweight (≥91st centile BMI) or obese (≥98th centile BMI) from three localities and assigned randomly to Families for Health V2 (60 families) or the usual care control (60 families) groups. Randomization will be stratified by locality (Coventry, Warwickshire, Wolverhampton).Families for Health V2 is a family-based intervention run in a community venue. Parents/carers and children attend parallel groups for 2.5 hours weekly for 10 weeks. The usual care arm will be the usual support provided within each NHS locality.A mixed-methods evaluation will be carried out. Child and parent participants will be assessed at home visits at baseline, 3-month (post-treatment) and 12-month follow-up. The primary outcome measure is the change in the children's BMI z-scores at 12 months from the baseline. Secondary outcome measures include changes in the children's waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. The parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style will also be assessed.Economic components will encompass the measurement and valuation of service utilization, including the costs of running Families for Health and usual care, and the EuroQol EQ-5D health outcomes. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained. A de novo decision-analytic model will estimate the lifetime cost-effectiveness of the Families for Health program.Process evaluation will document recruitment, attendance and drop-out rates, and the fidelity of Families for Health delivery. Interviews with up to 24 parents and children from each arm will investigate perceptions and changes made. DISCUSSION: This paper describes our protocol to assess the effectiveness and cost-effectiveness of a parenting approach for managing childhood obesity and presents challenges to implementation. TRIAL REGISTRATION: Current Controlled Trials http://ISRCTN45032201.

Validation of the Mothers Object Relations scales in 2-4 year old children and comparison with the Child-Parent Relationship Scale.

BACKGROUND: The quality of the parent-child relationship has an important effect on a wide range of child outcomes. The evaluation of interventions to promote healthy parenting and family relationships is dependent on outcome measures which can quantify the quality of parent-child relationships. Between the Mothers' Object Relations - Short Form (MORS-SF) scale for babies and the Child-parent Relationship Scale (C-PRS) there is an age gap where no validated scales are available. We report the development and testing of an adaptation of the MORS-SF; the MORS (Child) scale and its use in children from the age of 2 years to 4 years. This scale aims to capture the nature of the parent-child relationship in a form which is short enough to be used in population surveys and intervention evaluations. METHODS: Construct and criterion validity, item salience and internal consistency were assessed in a sample of 166 parents of children aged 2-4 years old and compared with that of the C-PRS. The performance of the MORS (Child) as part of a composite measure with the HOME inventory was compared with that of the C-PRS using data collected in a randomised controlled trial and the national evaluation of Sure Start. RESULTS: MORS (Child) performed well in children aged 2-4 with high construct and criterion validity, item salience and internal consistency. One item in the C-PRS failed to load on either subscale and parents found this scale slightly more difficult to complete than the MORS (Child). The two measures performed very similarly in a factor analysis with the HOME inventory producing almost identical loadings. CONCLUSIONS: Adapting the MORS-SF for children aged 2-4 years old produces a scale to assess parent-child relationships that is easy to use and outperforms the more commonly used C-PRS in several respects.

Health service use in families where children enter public care: a nested case control study using the General Practice Research Database.

BACKGROUND: At least 3% of children spend some of their childhood in public care and, as a group, have poor outcomes across a range of education, employment, health and social care outcomes. Research, using social care or government datasets, has identified a number of risk factors associated with children entering public care but the utility of risk factors in clinical practice is not established. This paper uses routine primary health care data to see if risk factors for children entering public care can be identified in clinical practice. METHODS: A nested case control methodology using routine primary care data from the United Kingdom. Health service use data were extracted for the 12 months before the case child entered public care and compared with 12 months of data for four control mother child pairs per case pair, matched on the age and sex of the child and the general practice. Exposures of interest were developed from a systematic review of the literature on risk factors associated with children entering public care. RESULTS: Conditional logistic regression was used to investigate the combined effect of more than one exposure of interest. Maternal mental illness (OR 2.51, 95% CI 1.55-4.05), maternal age at birth of the child, socio-economic status (5(th) quintile vs. 1(st) quintile OR 7.14, 95% CI 2.92-17.4), maternal drug use (OR 28.8, 95% CI 2.29-363), non attendance at appointments (OR 2.42, 95% CI 1.42-4.14), child mental illness (OR 2.65, 95% CI 1.42-4.96) and child admission to hospital (OR 3.31, 95% CI 1.21-9.02) were all significantly associated with children entering public care. Maternal use of primary care contraception services was negatively associated with children entering public care (OR 0.52, 95% CI 0.31-0.87). CONCLUSIONS: Differences in health service use can be identified from routine primary care data in mother child pairs where children enter public care after controlling for maternal age and socio-economic status. The interaction between different risk factors needs testing in a cumulative risk model using longitudinal datasets.

Childhood disability and socio-economic circumstances in low and middle income countries: systematic review.

BACKGROUND: The majority of children with disability live in low and middle income (LAMI) countries. Although a number of important reviews of childhood disability in LAMI countries have been published, these have not, to our knowledge, addressed the association between childhood disability and the home socio-economic circumstances (SEC). The objective of this study is to establish the current state of knowledge on the SECs of children with disability and their households in LAMI countries through a systematic review and quality assessment of existing research. METHODS: Electronic databases (MEDLINE; EMBASE; PUBMED; Web of Knowledge; PsycInfo; ASSIA; Virtual Health Library; POPLINE; Google scholar) were searched using terms specific to childhood disability and SECs in LAMI countries. Publications from organisations including the World Bank, UNICEF, International Monetary Fund were searched for. Primary studies and reviews from 1990 onwards were included. Studies were assessed for inclusion, categorisation and quality by 2 researchers. RESULTS: 24 primary studies and 13 reviews were identified. Evidence from the available literature on the association between childhood disability and SECs was inconsistent and inconclusive. Potential mechanisms by which poverty and low household SEC may be both a cause and consequence of disability are outlined in the reviews and the qualitative studies. The association of poor SECs with learning disability and behaviour problems was the most consistent finding and these studies had low/medium risk of bias. Where overall disability was the outcome of interest, findings were divergent and many studies had a high/medium risk of bias. Qualitative studies were methodologically weak. CONCLUSIONS: This review indicates that, despite socially and biologically plausible mechanisms underlying the association of low household SEC with childhood disability in LAMI countries, the empirical evidence from quantitative studies is inconsistent and contradictory. There is evidence for a bidirectional association of low household SEC and disability and longitudinal data is needed to clarify the nature of this association.

Measuring the impact and costs of a universal group based parenting programme: protocol and implementation of a trial.

BACKGROUND: Sub-optimal parenting is a common risk factor for a wide range of negative health, social and educational outcomes. Most parenting programmes have been developed in the USA in the context of delinquency prevention for targeted or indicated groups and the main theoretical underpinning for these programmes is behaviour management. The Family Links Nurturing Programme (FLNP) focuses on family relationships as well as behaviour management and is offered on a universal basis. As a result it may be better placed to improve health and educational outcomes. Developed in the UK voluntary sector, FLNP is popular with practitioners, has impressed policy makers throughout the UK, has been found to be effective in before/after and qualitative studies, but lacks a randomised controlled trial (RCT) evidence base. METHODS/DESIGN: A multi-centre, investigator blind, randomised controlled trial of the FLNP with a target sample of 288 south Wales families who have a child aged 2-4 yrs living in or near to Flying Start/Sure Start areas. Changes in parenting, parent child relations and parent and child wellbeing are assessed with validated measures immediately and at 6 months post intervention. Economic components include cost consequences and cost utility analyses based on parental ranking of states of quality of life. Attendance and completion rates and fidelity to the FLNP course delivery are assessed. A nested qualitative study will assess reasons for participation and non-participation and the perceived value of the programme to families. By the end of May 2010, 287 families have been recruited into the trial across four areas of south Wales. Recruitment has not met the planned timescales with barriers including professional anxiety about families entering the control arm of the trial, family concern about video and audio recording, programme facilitator concern about the recording of FLNP sessions for fidelity purposes and delays due to the new UK research governance procedures. DISCUSSION: Whilst there are strong theoretical arguments to support universal provision of parenting programmes, few universal programmes have been subjected to randomised controlled trials. In this paper we describe a RCT protocol with quantitative and qualitative outcome measures and an economic evaluation designed to provide clear evidence with regard to effectiveness and costs. We describe challenges implementing the protocol and how we are addressing these. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13919732.