Dataset Information

Effectiveness and cost-effectiveness of a universal parenting skills programme in deprived communities: multicentre randomised controlled trial.

ABSTRACT:

Objective

To evaluate the effectiveness and cost utility of a universally provided early years parenting programme.

Design

Multicentre randomised controlled trial with cost-effectiveness analysis.

Setting

Early years centres in four deprived areas of South Wales.

Participants

Families with children aged between 2 and 4 years. 286 families were recruited and randomly allocated to the intervention or waiting list control.

Intervention

The Family Links Nurturing Programme (FLNP), a 10-week course with weekly 2 h facilitated group sessions.

Main outcome measures

Negative and supportive parenting, child and parental well-being and costs assessed before the intervention, following the course (3 months) and at 9 months using standardised measures.

Results

There were no significant differences in primary or secondary outcomes between trial arms at 3 or 9 months. With '+' indicating improvement, difference in change in negative parenting score at 9 months was +0.90 (95%CI -1.90 to 3.69); in supportive parenting, +0.17 (95%CI -0.61 to 0.94); and 12 of the 17 secondary outcomes showed a non-significant positive effect in the FLNP arm. Based on changes in parental well-being (SF-12), the cost per quality-adjusted life year (QALY) gained was estimated to be £34 913 (range 21 485-46 578) over 5 years and £18 954 (range 11 664-25 287) over 10 years. Probability of cost per QALY gained below £30 000 was 47% at 5 years and 57% at 10 years. Attendance was low: 34% of intervention families attended no sessions (n=48); only 47% completed the course (n=68). Also, 19% of control families attended a parenting programme before 9-month follow-up.

Conclusions

Our trial has not found evidence of clinical or cost utility for the FLNP in a universal setting. However, low levels of exposure and contamination mean that uncertainty remains.

Trial registration

The trial is registered with Current Controlled Trials ISRCTN13919732.

SUBMITTER: Simkiss DE

PROVIDER: S-EPMC3733301 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness and cost-effectiveness of a universal parenting skills programme in deprived communities: multicentre randomised controlled trial.

Simkiss D E DE Snooks H A HA Stallard N N Kimani P K PK Sewell B B Fitzsimmons D D Anthony R R Winstanley S S Wilson L L Phillips C J CJ Stewart-Brown S S

BMJ open 20130801 8

<h4>Objective</h4>To evaluate the effectiveness and cost utility of a universally provided early years parenting programme.<h4>Design</h4>Multicentre randomised controlled trial with cost-effectiveness analysis.<h4>Setting</h4>Early years centres in four deprived areas of South Wales.<h4>Participants</h4>Families with children aged between 2 and 4 years. 286 families were recruited and randomly allocated to the intervention or waiting list control.<h4>Intervention</h4>The Family Links Nurturing ...[more]

PMID: 23906953

Similar Datasets

Project description:BackgroundIn contrast to evidence for interventions supporting victim/survivors of domestic violence and abuse (DVA), the effectiveness of perpetrator programmes for reduction of abuse is uncertain. This study aims to estimate the effectiveness and cost-effectiveness of a perpetrator programme for men.MethodsPragmatic two-group individually randomised controlled trial (RCT) with embedded process and economic evaluation. Five centres in southwest England and South Wales aim to recruit 316 (reduced from original target of 366) male domestic abuse perpetrators. These will be randomised 2:1 to a community-based domestic abuse perpetrator programme (DAPP) or usual care comparator with 12-month follow-up. Female partners/ex-partners will be invited to join the study. The intervention for men comprises 23 weekly sessions of a group programme delivered in voluntary sector domestic abuse services. The intervention for female partners/ex-partners is one-to-one support from a safety worker. Men allocated to usual care receive no intervention; however, they are free to access other services. Their partners/ex-partners will be signposted to support services. Data is collected at baseline, and 4, 8 and 12 months' follow-up. The primary outcome is men's self-reported abusive behaviour measured by the Abusive Behaviour Inventory (ABI-29) at 12 months. Secondary measures include physical and mental health status and resource use alongside the abuse measure ABI (ABI-R) for partners/ex-partners and criminal justice contact for men. A mixed methods process evaluation and qualitative study will explore mechanisms of effectiveness, judge fidelity to the intervention model using interviews and group observations. The economic evaluation, over a 1-year time horizon from three perspectives (health and social care, public sector and society), will employ a cost-consequences framework reporting costs alongside economic outcomes (Quality-Adjusted Life Years derived from EQ-5D-5L, SF-12 and CHU-9D, and ICECAP-A) as well as the primary and other secondary outcomes.DiscussionThis trial will provide evidence of the (cost)effectiveness of a DAPP. The embedded process evaluation will further insights in the experiences and contexts of participants and their journey through a perpetrator programme, and the study will seek to address the omission in other studies of economic evaluations.Trial registrationISRCTN15804282, April 1, 2019.

Project description:BackgroundAlmost half of the stroke patients admitted to geriatric rehabilitation has persisting problems after discharge. Currently, there is no evidence based geriatric rehabilitation programme available for older stroke patients, combining inpatient rehabilitation with adequate ambulatory aftercare in the community. Therefore, we developed an integrated multidisciplinary rehabilitation programme that includes aftercare for older persons with stroke. We evaluated the effectiveness of this newly developed rehabilitation programme in comparison to usual care.MethodsA multicentre randomised controlled trial was conducted in eight geriatric rehabilitation stroke units and their collaborating partners in primary care. The study population involved stroke patients and their informal caregivers who were aged 65 or over, living in the community before admission to geriatric rehabilitation, and expected to be able to return home after discharge. The programme consisted of three modules: inpatient neurorehabilitation, home-based self-management training, and stroke education. For patients, daily activity (FAI) was assessed as primary outcome and functional dependence (Katz-15), perceived quality of life (SSQoL) and social participation (IPA) as secondary outcomes. Additionally, among informal caregivers perceived care burden (self-rated burden VAS), objective care burden (Erasmus iBMG), and quality of life (CarerQol), were assessed as secondary outcomes.ResultsIn total 190 patients and 172 informal caregivers were included. Mean age of the patients in the intervention group was 78.9 years (SD = 7.0) and in the usual care group 79.0 years (SD = 6.5). Significant favourable effects for the programme were observed for the subscale autonomy outdoors of the IPA (- 2.15, P = .047, and for the informal caregivers perceived care burden (1.23, P = .048. For the primary outcome daily activity and the other secondary outcomes, no significant effects were observed.ConclusionThe integrated multidisciplinary programme had no effect on daily activity of older stroke patients. However, patients participating in the programme had a higher level of perceived autonomy of outdoor activities and their informal caregivers perceived a lower care burden. The programme might be promising in providing adequate (after) care, although adaptation of the programme is recommended to increase its feasibility and improve its effects.Trial registrationCurrent Controlled Trials ISRCTN62286281 . Registered 19-3-2010.

Project description:IntroductionAdolescents with brain injury frequently have difficulties with social competence, which persist into adulthood affecting their participation in daily life. To date, there has been limited research into the efficacy of social competence interventions in this population. Research from the Program for the Education and Enrichment of Relational Skills (PEERS) has demonstrated significant improvements in social competence skills, maintained at 1-year to 5-year follow-up, for adolescents with autism spectrum disorder. PEERS has not yet been tested among adolescents with brain injury. This protocol describes a pragmatic, parallel two-group pre-test post-test randomised waitlist control trial across two sites in Australia, which aims to evaluate the feasibility, acceptability and efficacy of PEERS in adolescents with brain injury compared with usual care.Methods and analysisForty adolescents with an acquired brain injury or cerebral palsy will be randomly assigned to either the 14-week PEERS group or waitlist care as usual group. The waitlist group will then receive PEERS following the 26-week retention time point. Outcomes will be assessed at baseline, 14 weeks (immediately postintervention) and 26 weeks follow-up (retention). The primary outcomes are self-report and parent report on the Social Skills Improvement System Rating Scales immediately post PEERS at 14 weeks. Secondary outcomes include increased frequency of get-togethers with peers with reduced conflict and increased adolescent self-reported knowledge of social skills. Acceptability and feasibility will be examined through qualitative analysis of focus group data collected after the completion of each group.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/17/QRCH/87), The University of Queensland (2017000864) and the Cerebral Palsy Alliance Ethics Committee (20170802/HREC:EC00402). The findings will be disseminated in peer-reviewed journals, by conference presentation and newsletters to consumers.Trial registration numberACTRN12617000723381.

Project description:PurposeSupporting the provision of intensive care medicine through telehealth potentially improves process quality. This may improve patient recovery and long-term outcomes. We investigated the effectiveness of a multifaceted telemedical programme on the adherence to German quality indicators (QIs) in a regional network of intensive care units (ICUs) in Germany.MethodsWe conducted an investigator-initiated, large-scale, open-label, stepped-wedge cluster randomised controlled trial enrolling adult ICU patients with an expected ICU stay of ≥ 24 h. Twelve ICU clusters in Berlin and Brandenburg were randomly assigned to three sequence groups to transition from control (standard care) to the intervention condition (telemedicine). The quality improvement intervention consisted of daily telemedical rounds guided by eight German acute ICU care QIs and expert consultations. Co-primary effectiveness outcomes were patient-specific daily adherence (fulfilled yes/no) to QIs, assessed by a central end point adjudication committee. Analyses used mixed-effects logistic modelling adjusted for time. This study is completed and registered with ClinicalTrials.gov (NCT03671447).ResultsBetween September 4, 2018, and March 31, 2020, 1463 patients (414 treated on control, 1049 on intervention condition) were enrolled at ten clusters, resulting in 14,783 evaluated days. Two randomised clusters recruited no patients (one withdrew informed consent; one dropped out). The intervention, as implemented, significantly increased QI performance for "sedation, analgesia and delirium" (adjusted odds ratio (99.375% confidence interval [CI]) 5.328, 3.395-8.358), "ventilation" (OR 2.248, 1.198-4.217), "weaning from ventilation" (OR 9.049, 2.707-30.247), "infection management" (OR 4.397, 1.482-13.037), "enteral nutrition" (OR 1.579, 1.032-2.416), "patient and family communication" (OR 6.787, 3.976-11.589), and "early mobilisation" (OR 3.161, 2.160-4.624). No evidence for a difference in adherence to "daily multi-professional and interdisciplinary clinical visits" between both conditions was found (OR 1.606, 0.780-3.309). Temporal trends related and unrelated to the intervention were detected. 149 patients died during their index ICU stay (45 treated on control, 104 on intervention condition).ConclusionA telemedical quality improvement program increased adherence to seven evidence-based German performance indicators in acute ICU care. These results need further confirmation in a broader setting of regional, non-academic community hospitals and other healthcare systems.

Dataset Information

Effectiveness and cost-effectiveness of a universal parenting skills programme in deprived communities: multicentre randomised controlled trial.

Objective

Design

Setting

Participants

Intervention

Main outcome measures

Results

Conclusions

Trial registration

Publications

Effectiveness and cost-effectiveness of a universal parenting skills programme in deprived communities: multicentre randomised controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets