Search

Background: Parents of children with intellectual disability are 1.5-2 times more likely than other parents to report mental health difficulties. There is a lack of clinically effective and cost-effective group well-being interventions designed for family carers of young children with intellectual disability. Aim: To examine the feasibility of a randomised controlled trial of the clinical effectiveness and cost-effectiveness of the Early Positive Approaches to Support (E-PAtS) intervention. Design: A feasibility study (including randomisation of families into a two-arm trial), questionnaires to assess the feasibility of proposed outcome measures (including resource use and health-related quality of life) and practitioner/family carer interviews. An additional question was included in an online UK survey of families, conducted by the research team to assess usual practice, and a survey of provider organisations. Setting: Families recruited from community contexts (i.e. third sector, local authority services, special schools) and self-referral. The E-PAtS intervention was delivered by trained community-based providers. Participants: Families with at least one child aged 1.5-5 years with an intellectual disability. At least one parent had to have English-language ability (spoken) for E-PAtS programme participation and participants had to provide informed consent. Interventions: E-PAtS intervention - two caregivers from each family invited to eight 2.5-hour group sessions with usual practice. Usual practice - other support provided to the family, including other parenting support. Objectives: To assess randomisation willingness/feasibility, recruitment of providers/parents, retention, usual practice, adherence, fidelity and feasibility of proposed outcome measures (including the Warwick-Edinburgh Mental Well-Being Scale as the proposed primary outcome measure, and parent anxiety/depression, parenting, family functioning/relationships, child behavioural/emotional problems and adaptive skills, child and parent quality of life, and family services receipt as the proposed secondary outcome measures). Results: Seventy-four families (95 carers) were recruited from three sites (with 37 families allocated to the intervention). From referrals, the recruitment rate was 65% (95% confidence interval 56% to 74%). Seventy-two per cent of families were retained at the 12-month follow-up (95% confidence interval 60% to 81%). Exploratory regression analysis showed that the mean Warwick-Edinburgh Mental Well-Being Scale well-being score was 3.96 points higher in the intervention group (95% confidence interval -1.39 to 9.32 points) at 12 months post randomisation. High levels of data completeness were achieved on returned questionnaires. Interviews (n = 25) confirmed that (1) recruitment, randomisation processes and the intervention were acceptable to family carers, E-PAtS facilitators and community staff; (2) E-PAtS delivery were consistent with the logic model; and (3) researchers requesting consent in future for routine data would be acceptable. Recorded E-PAtS sessions demonstrated good fidelity (96% of components present). Adherence (i.e. at least one carer from the family attending five out of eight E-PAtS sessions) was 76%. Health-related quality-of-life and services receipt data were gathered successfully. An online UK survey to assess usual practice (n = 673) showed that 10% of families of young children with intellectual disability received any intervention over 12 months. A provider survey (n = 15) indicated willingness to take part in future research. Limitations: Obtaining session recordings for fidelity was difficult. Recruitment processes need to be reviewed to improve diversity and strategies are needed to improve primary outcome completion. Conclusions: Study processes were feasible. The E-PAtS intervention was well received and outcomes for families were positive. A barrier to future organisation participation is funding for intervention costs. A definitive trial to test the clinical effectiveness and cost-effectiveness of E-PAtS would be feasible. Trial registration: Current Controlled Trials ISRCTN70419473. Funding: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 10, No. 2. See the NIHR Journals Library website for further project information. [ABSTRACT FROM AUTHOR]

Background: Parents of children with intellectual disabilities are likely to experience poorer mental well-being and face challenges accessing support. Early Positive Approaches to Support (E-PAtS) is a group-based programme, co-produced with parents and professionals, based on existing research evidence and a developmental systems approach to support parental mental well-being. The aim of this study was to assess the feasibility of community service provider organisations delivering E-PAtS to parents/family caregivers of young children with intellectual disability, to inform a potential definitive randomised controlled trial of the effectiveness and cost-effectiveness of E-PAtS. Methods: This study was a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to two parents/family caregivers of a child (18 months to <6 years old) with intellectual disability were recruited at research sites and allocated to intervention (E-PAtS and usual practise) or control (usual practise) on a 1:1 basis at cluster (family) level. Data were collected at baseline and 3 and 12 months' post-randomisation. The following feasibility outcomes were assessed: participant recruitment rates and effectiveness of recruitment pathways; retention rates; intervention adherence and fidelity; service provider recruitment rates and willingness to participate in a future trial; barriers and facilitating factors for recruitment, engagement, and intervention delivery; and feasibility of collecting outcome measures. Results: Seventy-four families were randomised to intervention or control (n = 37). Retention rates were 72% at 12 months post-randomisation, and completion of the proposed primary outcome measure (WEMWBS) was 51%. Recruitment of service provider organisations and facilitators was feasible and intervention implementation acceptable. Adherence to the intervention was 76% and the intervention was well-received by participants; exploratory analyses suggest that adherence and attendance may be associated with improved well-being. Health economic outcome measures were collected successfully and evidence indicates that linkage with routine data would be feasible in a future trial. Conclusions: The E-PAtS Feasibility RCT has demonstrated that the research design and methods of intervention implementation are generally feasible. Consideration of the limitations of this feasibility trial and any barriers to conducting a future definitive trial, do however, need to be considered by researchers. Clinical Trial Registration: https://www.isrctn.com, identifier: ISRCTN70419473. [ABSTRACT FROM AUTHOR]

Background: The short-term effectiveness (to 24 months post partum) of a preventative home-visiting intervention, the Family Nurse Partnership, was previously assessed in the Building Blocks trial (BB:0-2). Objectives: The objectives were to establish the medium-term effectiveness of the Family Nurse Partnership in reducing maltreatment and improving maternal health (second pregnancies) and child health, developmental and educational outcomes (e.g. early educational attendance, school readiness); to explore effect moderators and mediators; and to describe the costs of enhancing usually provided health and social care with the Family Nurse Partnership. Design: Children and their mothers from an existing trial cohort were followed up using routine data until the child was 7 years of age. Setting: This study was set in 18 partnerships between local authorities and health-care organisations in England. Participants: The participants were mothers [and their firstborn child(ren)] recruited as pregnant women aged = 19 years, in local authority Family Nurse Partnership catchment areas, at < 25 weeks' gestation, able to provide consent and able to converse in English. Participants mandatorily withdrawn (e.g. owing to miscarriage) from the BB:0-2 trial were excluded. Interventions: The intervention comprised up to a maximum of 64 home visits by specially trained family nurses from early pregnancy until the firstborn child was 2 years of age, plus usually provided health and social care support. The comparator was usual care alone. Main outcome measures: The primary outcome measure was child-in-need status recorded at any time during follow-up. The secondary outcomes were as follows: (1) referral to social services, child protection registration (plan), child-in-need categorisation, looked-after status, recorded injuries and ingestions at any time during follow-up; (2) early child care and educational attendance, school readiness (Early Years Foundation Stage Profile score) and attainment at Key Stage 1; and (3) health-care costs. Data sources: The following data sources were used: maternally reported baseline and follow-up data (BB:0-2), Hospital Episode Statistics data (NHS Digital), social care and educational data (National Pupil Database) and abortions data (Department of Health and Social Care). Results: There were no differences between study arms in the rates of referral to social services, being registered as a child in need, receiving child protection plans, entering care or timing of first referral for children subsequently assessed as in need. There were no differences between study arms in rates of hospital emergency attendance, admission for injuries or ingestions, or in duration of stay for admitted children. Children in the Family Nurse Partnership arm were more likely to achieve a good level of development at reception age (school readiness), an effect strengthened when adjusting for birth month. Differences at Key Stage 1 were not statistically different, but, after adjusting for birth month, children in the Family Nurse Partnership arm were more likely to reach the expected standard in reading. Programme effects were greater for boys (Key Stage 1: writing); children of younger mothers (Key Stage 1: writing, Key Stage 1: mathematics); and children of mothers not in employment, education or training at study baseline (Key Stage 1: writing). There were no differences between families who were part of the Family Nurse Partnership and those who were not for any other outcome. The differences between study arms in resource use and costs were negligible. Limitations: The outcomes are constrained to those available from routine sources. Conclusions: There is no observable benefit of the programme for maltreatment or maternal outcomes, but it does generate advantages in school readiness and attainment at Key Stage 1. [ABSTRACT FROM AUTHOR]

Background: The Fostering Changes programme was developed by the Adoption and Fostering National Team at the Maudsley Hospital, South London, in conjunction with King's College London. It is a 12-week group-based training programme for foster and kin carers, which aims to build positive relationships between carers and children, encourage positive child behaviour and set appropriate limits, through a practical skills-based approach. The programme also aims to improve foster carers' understanding of the causes of children's social and emotional difficulties and their confidence in applying this knowledge in various situations.Methods: This is a pragmatic open-label individually randomised controlled trial, with embedded process evaluation. A total of 237 participants will be recruited from Welsh Local Authorities and Independent Fostering Providers; those allocated to the intervention group will be offered enrolment in the next Fostering Changes programme group at their site. Participants in the control group will be offered the Fostering Changes programme at the end of the follow-up period. Data will be collected at baseline, immediately following the 12 week Fostering Changes intervention, and 12 months from the start of the Fostering Changes programme. The primary outcome measure assesses the extent to which carers feel able to cope with and make positive changes to the lives of their foster children and is measured by the Carer Efficacy Questionnaire at 12 months.Discussion: The trial will determine whether the Fostering Changes programme, in the long term, can deliver important, significant differences to the way foster carers build positive relationships with their foster children, encourage positive child behaviour and set appropriate limits, compared with usual care.Trial Registration: International Standard Randomised Controlled Trial Number, ISRCTN19090228 . Registered on 11 January 2017. [ABSTRACT FROM AUTHOR]

Introduction Child 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 analysis We 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 dissemination The 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. [ABSTRACT FROM AUTHOR]

Background: The Nurse Family Partnership programme was developed in the USA where it is made available to pregnant young mothers in some socially deprived geographic areas. The related Family Nurse Partnership programme was introduced in England by the Department of Health in 2006 with the aim of improving outcomes for the health, wellbeing and social circumstances of young first-time mothers and their children. Methods / design: This multi-centre individually randomised controlled trial will recruit 1600 participants from 18 Primary Care Trusts in England, United Kingdom. The trial will evaluate the effectiveness of Family Nurse Partnership programme and usual care versus usual care for nulliparous pregnant women aged 19 or under, recruited by 24 weeks gestation and followed until the child's second birthday. Data will be collected from participants at baseline, 34-36 weeks gestation, 6, 12, 18 and 24 months following birth. Routine clinical data will be collected from maternity, primary care and hospital episodes statistics. Four primary outcomes are to be reported from the trial: birth weight; prenatal tobacco use; child emergency attendances and/or admissions within two years of birth; second pregnancy within two years of first birth. Discussion: This trial will evaluate the effectiveness and cost effectiveness of the Family Nurse Partnership in England. The findings will provide evidence on pregnancy and early childhood programme outcomes for policy makers, health professionals and potential recipients in three domains (pregnancy and birth, child health and development, and parental life course and self-sufficiency) up to the child's second birthday. [ABSTRACT FROM AUTHOR]

Background: There is a paucity of research into interventions that help people with intellectual disabilities learn to read. This feasibility study examines whether an online reading programme, Headsprout, with additional support strategies and supervision (the intervention), can be delivered by support workers/family carers and the feasibility of conducting a later large-scale effectiveness trial., Methods: The study used a 2-arm randomised controlled trial (RCT) design with an embedded process evaluation using a mixed methods approach., Results: Thirty-six adults with intellectual disabilities were recruited. Informed consent and data were obtained remotely. Progression criteria for recruitment, retention, randomisation and usual practice were met; intervention adherence and fidelity were poor. Pressure on support services was a key barrier., Conclusions: Whilst progression to a large-scale effectiveness trial was not recommended, the success of conducting an RCT and remotely obtaining informed consent and data from adults with intellectual disabilities opens opportunities for increased participation in research for a currently under-represented group., Registration: ISRCTN11409097., (© 2024 The Author(s). Journal of Applied Research in Intellectual Disabilities published by John Wiley & Sons Ltd.)

Introduction: Rapid diagnostic centres (RDCs) are being implemented across the UK to accelerate the assessment of vague suspected cancer symptoms. Targeted behavioural interventions are needed to augment RDCs that serve socioeconomically deprived populations who are disproportionately affected by cancer, have lower cancer symptom awareness and are less likely to seek help for cancer symptoms. The aim of this study is to assess the feasibility and acceptability of delivering and evaluating a community-based vague cancer symptom awareness intervention in an area of high socioeconomic deprivation., Methods and Analysis: Intervention materials and messages were coproduced with local stakeholders in Cwm Taf Morgannwg, Wales. Cancer champions will be trained to deliver intervention messages and distribute intervention materials using broadcast media (eg, local radio), printed media (eg, branded pharmacy bags, posters, leaflets), social media (eg, Facebook) and attending local community events. A cross-sectional questionnaire will include self-reported patient interval (time between noticing symptoms to contacting the general practitioner), cancer symptom recognition, cancer beliefs and barriers to presentation, awareness of campaign messages, healthcare resource use, generic quality of life and individual and area-level deprivation indicators. Consent rates and proportion of missing data for patient questionnaires (n=189) attending RDCs will be measured. Qualitative interviews and focus groups will assess intervention acceptability and barriers/facilitators to delivery., Ethics and Dissemination: Ethical approval for this study was given by the London-West London & GTAC Research Ethics (21/LO/0402). This project will inform a potential future controlled study to assess intervention effectiveness in reducing the patient interval for vague cancer symptoms. The results will be critical to informing national policy and practice regarding behavioural interventions to support RDCs in highly deprived populations., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Measure effectiveness of family nurse partnership (FNP) home-visiting programme in reducing maltreatment and improving maternal health and child health, developmental and educational outcomes; explore effect moderators, mediators; describe costs., Design: Follow-up of BB:0-2 trial cohort (ISRCTN:23019866) up to age 7 years in England using record linkage., Participants: 1618 mothers aged 19 years or younger and their firstborn child(ren) recruited to BB:0-2 trial at less than 25 weeks gestation and not mandatorily withdrawn from trial or opted out. Intervention families were offered up to a maximum of 64 home visits by specially trained nurses from pregnancy until firstborn child was 2 years old, plus usually provided health and social care support. Comparator was usual care alone., Outcome Measures: Primary outcome: state-verified child-in-need status recorded at any time during follow-up., Secondary Outcomes: referral to social services, child protection registration (plan), child-in-need categorisation, looked-after status, recorded injuries and ingestions any time during follow-up, early childcare and educational attendance, school readiness and attainment at key stage 1 (KS1), healthcare costs., Results: Match rates for 1547 eligible children (1517 singletons, 15 sets of twins) were 98.3% (NHS Digital) and 97.4% (National Pupil Database). There was no difference between study arms in the proportion of children being registered as in need (adjusted OR 0.98, 95% CI 0.74 to 1.31), or for any other measure of maltreatment. Children in the FNP arm were more likely to achieve a good level of development at reception age (school readiness) (adjusted OR 1.24, 95% CI 1.01 to 1.52). After adjusting for birth month, children in FNP arm were more likely to reach the expected standard in reading at KS1 (adjusted OR 1.26, 95% CI 1.02 to 1.57). We found no trial arm differences for resource use and costs., Conclusions: FNP did not improve maltreatment or maternal outcomes. There was evidence of small advantages in school readiness and attainment at KS1., Trial Registration Number: ISRCTN23019866., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Factors that affect public and professionals' attitudes towards the collection and linkage of health and other data have been explored in the literature. Thus far there has been no study exploring attitudes towards the collection of child maltreatment data., Objectives: Our aim is to explore attitudes regarding the collection and linkage of maltreatment data for research., Methods: Participants included younger mothers, older mothers, care-experienced young people, and professionals who were responsible for recording child maltreatment data. Four face-to-face focus groups were conducted, one with younger mothers (n = 6), one with older mothers (n = 10), and two with care-experienced young people (n = 6 and n = 5). An online focus group was conducted with professionals (n = 10), two of whom additionally participated in telephone interviews. Transcribed audio-recorded data were inductively coded, a portion were double-coded by a second researcher, and thematically analysed., Results: Three major themes were identified. The first concerned issues of consent, specifically the conditions for providing consent and factors influencing this. The second concerned trust in data security and validity, the organisations and individuals providing and using the data, and how the information provided shapes attitudes. The third theme explored the benefits of research and the researchers' role in child protection. Participants wanted the choice of providing consent for data collection, especially when consenting on behalf of another, but there were concerns that maltreated children were unidentifiable in anonymised datasets. Care-experienced young people were concerned about data collection from Social Services records due to their sensitivity. There was a general lack of understanding about how research data is viewed and the accuracy of records., Conclusions: Novel findings in the study were strongly related to the sensitive nature of the topic. The findings may be particularly useful when designing research studies and participant materials and a co-productive approach to this should be taken., Competing Interests: Conflict of interests: All authors declare that they have no competing interests.

Introduction: Researchers are increasingly using routinely collected data in addition to, or instead of, other data collection methods. The UK government continues to invest in research centres to encourage use of these data, and trials and cohort studies utilise data linkage methods in the follow-up of participants. This does not come without its limitations and challenges, such as data access delays., Objective: This paper outlines the challenges faced by three projects utilising individual-level routinely-collected linked data for the longer-term follow-up of participants., Methods: These studies are varied in design, study population and data providers. One researcher was common to the three studies and collated relevant study correspondence, formal documentary evidence such as data sharing agreements and, where relevant, meeting records to review. Key themes were identified and reviewed by other members of the research teams. Mitigating strategies were identified and discussed with a data provider representative and a broader group of researchers to finalise the recommendations presented., Results: The challenges discussed are grouped into five themes: Data application process; Project timelines; Dependencies and considerations related to consent; Information Governance; Contractual. In presenting our results descriptively we summarise each case study, identify the main cross-cutting themes and consider the potential for mitigation of challenges., Conclusions: We make recommendations that identify responsibilities for both researchers and data providers for mitigating and managing data access challenges. A continued conversation within the research community and with data providers is needed to continue to enable researchers to access and utilise the wealth of routinely-collected data available. The suggestions made in this paper will help researchers be better prepared to deal with the challenges of applying for data from multiple data providers., Competing Interests: Statement on conflicts of interest: None declared