Dataset Information

A community-based intervention (Young SMILES) to improve the health-related quality of life of children and young people of parents with serious mental illness: randomised feasibility protocol.

ABSTRACT:

Background

Children and young people of parents with mental illness (COPMI) are at risk of poor mental, physical and emotional health, which can persist into adulthood. They also experience poorer social outcomes and wellbeing as well as poorer quality of life than their peers with 'healthy' parents. The needs of COPMI are likely to be significant; however, their prevalence is unknown, although estimates suggest over 60% of adults with a serious mental illness have children. Many receive little or no support and remain 'hidden', stigmatised or do not regard themselves as 'in need'. Recent UK policies have identified supporting COPMI as a key priority, but this alone is insufficient and health-related quality of life has been neglected as an outcome.

Methods/design

An age-appropriate standardised intervention for COPMI, called Young SMILES, was developed in collaboration with service users, National Health Service (NHS) and non-NHS stakeholders in our previous work. This protocol describes a randomised feasibility trial comparing Young SMILES with usual care, involving 60 families that will be identified through third sector organisations and NHS services, and recruited and randomised on a 1:1 basis to receive Young SMILES or usual care. Outcomes of the feasibility trial are rates of recruitment, follow-up and withdrawals, intervention uptake, and engagement. The optimal child-reported outcomes will also be determined alongside the assessment of resource use. A qualitative evaluation conducted at 3-months will explore the experiences and views of children and young people as well as parents accessing the intervention and the facilitators delivering the intervention.

Discussion

This paper details the rationale, design, training and recruitment methods for a feasibility study to inform the design and effective implementation of a larger scale randomised controlled trial of Young SMILES.

Trial registration

ISRCTN36865046 , registered 18 December 2015.

SUBMITTER: Gellatly J

PROVIDER: S-EPMC6186077 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A community-based intervention (Young SMILES) to improve the health-related quality of life of children and young people of parents with serious mental illness: randomised feasibility protocol.

Gellatly Judith J Bee Penny P Gega Lina L Bower Peter P Hunter Diane D Stewart Paul P Stanley Nicky N Calam Rachel R Holt Kim K Wolpert Miranda M Douglas Simon S Green Jonathan J Kolade Adekeye A Callender Craig C Abel Kathryn M KM

Trials 20181011 1

<h4>Background</h4>Children and young people of parents with mental illness (COPMI) are at risk of poor mental, physical and emotional health, which can persist into adulthood. They also experience poorer social outcomes and wellbeing as well as poorer quality of life than their peers with 'healthy' parents. The needs of COPMI are likely to be significant; however, their prevalence is unknown, although estimates suggest over 60% of adults with a serious mental illness have children. Many receive ...[more]

PMID: 30314509

Similar Datasets

Project description:BackgroundPeople with a serious mental illness are more likely to smoke more and to be more dependent smokers than the general population. This may be due to a wide range of factors that could include a common aetiology to both smoking and the illness, self medication, smoking to alleviate adverse effects of medications, boredom in the existing environment, or a combination of these factors. It is important to undertake this review to facilitate improvements in both the health and safety of people with serious mental illness who smoke, and to reduce the overall burden of costs (both financial and health) to the smoker and, eventually, to the taxpayer.ObjectivesTo review the effects of smoking cessation advice for people with serious mental illness.Search methodsWe searched the Cochrane Schizophrenia Group Specialized Trials Register up to 2 April 2015, which is based on regular searches of CENTRAL, BIOSIS, PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, and trial registries. We also undertook unsystematic searches of a sample of the component databases (BNI, CINHAL, EMBASE, MEDLINE, and PsycINFO), up to 2 April 2015, and searched references of all identified studiesSelection criteriaWe planned to include all randomised controlled trials (RCTs) that focussed on smoking cessation advice versus standard care or comparing smoking cessation advice with other more focussed methods of delivering care or information.Data collection and analysisThe review authors (PK, AC, and DB) independently screened search results but did not identify any trials that fulfilled the inclusion criteria of this review.Main resultsWe did not identify any RCTs that evaluated advice regarding smoking cessation for people with serious mental illness. The excluded studies illustrate that randomisation of packages of care relevant to smokers with serious mental illness is possible.Authors' conclusionsPeople with serious mental illness are more likely to smoke than the general population. Yet we could not find any high quality evidence to guide the smoking cessation advice healthcare professionals pass onto service users. This is an area where trials are possible and needed.

Project description:BackgroundPeople with severe mental illness (e.g. psychosis, bipolar disorder) experience poor oral health compared to the general population as shown by more decayed, missing and filled teeth and a higher prevalence of periodontal disease. Attending dental services allows treatment of oral health problems and support for prevention. However, people with severe mental illness face multiple barriers to attending routine dental appointments and often struggle to access care. Link work interventions use non-clinical support staff to afford vulnerable populations the capacity, opportunity, and motivation to navigate use of services. The authors have co-developed with service users a link work intervention for supporting people with severe mental illness to access routine dental appointments. The Mouth Matters in Mental Health Study aims to explore the feasibility and acceptability of this intervention within the context of a feasibility randomised controlled trial (RCT) measuring outcomes related to the recruitment of participants, completion of assessments, and adherence to the intervention. The trial will closely monitor the safety of the intervention and trial procedures.MethodsA feasibility RCT with 1:1 allocation to two arms: treatment as usual (control) or treatment as usual plus a link work intervention (treatment). The intervention consists of six sessions with a link worker over 9 months. Participants will be adults with severe mental illness receiving clinical input from secondary care mental health service and who have not attended a planned dental appointment in the past 3 years. Assessments will take place at baseline and after 9 months. The target recruitment total is 84 participants from across three NHS Trusts. A subset of participants and key stakeholders will complete qualitative interviews to explore the acceptability of the intervention and trial procedures.DiscussionThe link work intervention aims to improve dental access and reduce oral health inequalities in people with severe mental illness. There is a dearth of research relating to interventions that attempt to improve oral health outcomes in people with mental illness and the collected feasibility data will offer insights into this important area.Trial registrationThe trial was preregistered on ISRCTN (ISRCTN13650779) and ClinicalTrials.gov (NCT05545228).

Project description:BackgroundPeer support provides the opportunity for peers with experiential knowledge of a mental illness to give emotional, appraisal and informational assistance to current service users, and is becoming an important recovery-oriented approach in healthcare for people with mental illness.ObjectivesTo assess the effects of peer-support interventions for people with schizophrenia or other serious mental disorders, compared to standard care or other supportive or psychosocial interventions not from peers.Search methodsWe searched the Cochrane Schizophrenia Group's Study-Based Register of Trials on 27 July 2016 and 4 July 2017. There were no limitations regarding language, date, document type or publication status.Selection criteriaWe selected all randomised controlled clinical studies involving people diagnosed with schizophrenia or other related serious mental illness that compared peer support to standard care or other psychosocial interventions and that did not involve 'peer' individual/group(s). We included studies that met our inclusion criteria and reported useable data. Our primary outcomes were service use and global state (relapse).Data collection and analysisThe authors of this review complied with the Cochrane recommended standard of conduct for data screening and collection. Two review authors independently screened the studies, extracted data and assessed the risk of bias of the included studies. Any disagreement was resolved by discussion until the authors reached a consensus. We calculated the risk ratio (RR) and 95% confidence interval (CI) for binary data, and the mean difference and its 95% CI for continuous data. We used a random-effects model for analyses. We assessed the quality of evidence and created a 'Summary of findings' table using the GRADE approach.Main resultsThis review included 13 studies with 2479 participants. All included studies compared peer support in addition to standard care with standard care alone. We had significant concern regarding risk of bias of included studies as over half had an unclear risk of bias for the majority of the risk domains (i.e. random sequence generation, allocation concealment, blinding, attrition and selective reporting). Additional concerns regarding blinding of participants and outcome assessment, attrition and selective reporting were especially serious, as about a quarter of the included studies were at high risk of bias for these domains.All included studies provided useable data for analyses but only two trials provided useable data for two of our main outcomes of interest, and there were no data for one of our primary outcomes, relapse. Peer support appeared to have little or no effect on hospital admission at medium term (RR 0.44, 95% CI 0.11 to 1.75; participants = 19; studies = 1, very low-quality evidence) or all-cause death in the long term (RR 1.52, 95% CI 0.43 to 5.31; participants = 555; studies = 1, very low-quality evidence). There were no useable data for our other prespecified important outcomes: days in hospital, clinically important change in global state (improvement), clinically important change in quality of life for peer supporter and service user, or increased cost to society.One trial compared peer support with clinician-led support but did not report any useable data for the above main outcomes.Authors' conclusionsCurrently, very limited data are available for the effects of peer support for people with schizophrenia. The risk of bias within trials is of concern and we were unable to use the majority of data reported in the included trials. In addition, the few that were available, were of very low quality. The current body of evidence is insufficient to either refute or support the use of peer-support interventions for people with schizophrenia and other mental illness.

Dataset Information

A community-based intervention (Young SMILES) to improve the health-related quality of life of children and young people of parents with serious mental illness: randomised feasibility protocol.

Background

Methods/design

Discussion

Trial registration

Publications

A community-based intervention (Young SMILES) to improve the health-related quality of life of children and young people of parents with serious mental illness: randomised feasibility protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets