Mapping and evaluating services for children with learning disabilities and behaviours that challenge
| ISRCTN | ISRCTN88920546 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88920546 |
| IRAS number | 310149 |
| Secondary identifying numbers | CPMS 52467, IRAS 310149 |
- Submission date
- 10/05/2022
- Registration date
- 05/07/2022
- Last edited
- 02/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
1 in every 5 children with a learning disability in the UK displays behaviours that challenge. These are not a medical diagnosis, but are behaviours (like aggression or self-injury) that may cause harm to the child or other people or prevent the child from being included in the community. Children with learning disabilities and behaviours that challenge are at risk of negative outcomes (like abusive care), their families are more likely to experience stress, and these children’s care is costly for services. When the National Institute of Health and Care Excellence (NICE) reviewed the evidence, they found little research about how best to design and deliver health and care services to these children. This research is about community-based services across England that support children with learning disabilities and behaviours that challenge, and their families. The researchers want to find out if the way that services are structured and organised (known as “service models”) has any effect on the outcomes of children with learning disabilities and behaviours that challenge and their families. They also want to understand the experiences of children and families, and the ways that services for children with learning disabilities and behaviours that challenge work with families, carers, children and young people to develop services with them.
Who can participate?
Services from Stage 1 that are eligible and would be interested to take part. To be eligible, services must have been included in Stage 1 analysis and nothing significant has changed in their service model since the analysis. Services must have also been established for more than 1 year and have more than 10 children typically referred/re-referred over 6 months.
Family carers and children with learning disabilities and behaviours that challenge who have been referred/re-referred into the service, and are eligible to take part, will also be invited to take part in the current study. To be eligible, children must be aged 0-15 years of age and have a learning disability as defined administratively or otherwise by the service. The child must have been referred at least in part for support in relation to behaviours that challenge. Family carers must consent to take part in the research and they are able to complete the research in English.
Other professionals will also be invited to take part in the study. These professionals will include: health or social care/education staff who receive training or advice, or are involved in individual cases of children with learning disabilities and behaviours that challenge; commissioners of community services for these children; and staff (internal or external) who are involved in co-production in services.
What does the study involve?
The researchers will select 15 services (from five different service models identified in Stage 1 of the MELD project) to study in detail. They will ask families of 244 children newly referred to these services to complete questionnaires when they first come to the service and again after 12 months. They will gather detailed information about each service (like how many children they see in the year, and estimate costs), and they will ask people who are involved in the children’s care (but not employed by the service) how satisfied they are with the service. The researchers will also interview children (using special communication techniques), families, and staff in each service model about their experiences receiving and delivering care, as well as reviewing any relevant documents. Family carers and professionals in our advisory groups, as well as members of the study team, will help the researchers to select from all Stage 1 services or their own networks four examples of co-production; where services work with children with a learning disability and/or families to design or improve services together. The researchers will carry out additional interviews with children, family carers, and staff to find out how co-production is working, how much it costs, and will review any relevant documents (e.g., policies, if any).
What are the possible benefits and risks of participating?
There are no direct and immediate benefits to taking part in this study, but participation will enable the researchers to evaluate the different identified service models for children with learning disabilities and behaviours that challenge in England. This will contribute to the evidence base about community-based service provision for these children, which may inform developments in service provision across England. The researchers are not aware of any risks related to taking part in this study.
Where is the study run from?
University of Warwick (UK)
When is the study starting and how long is it expected to run for?
February 2021 to July 2026
Who is funding the study?
National Institute for Health Research Health and Social Care Delivery Research (UK)
Who is the main contact?
Nicholas Manktelow, n.h.manktelow@bham.ac.uk
Contact information
Scientific
Intellectual Disabilities Research Institute (IDRIS)
School of Social Policy and Society
University of Birmingham
Edgbaston
Birmingham
B15 2TN
United Kingdom
 ORCID ID |
0000-0002-0495-8270 |
|---|---|
| r.hastings@bham.ac.uk |
Scientific
Intellectual Disabilities Research Institute (IDRIS)
School of Social Policy and Society
University of Birmingham
Edgbaston
Birmingham
B15 2TN
United Kingdom
| ORCID ID |
0000-0001-6304-5183 |
|---|---|
| n.h.manktelow@bham.ac.uk |
Study information
| Study design | Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Mapping and evaluating services for children with learning disabilities and behaviours that challenge (MELD): stage 2 |
| Study acronym | MELD |
| Study objectives | For children with learning disabilities with behaviour that challenges, the specialist behavioural service model leads to better outcomes than other service models. |
| Ethics approval(s) | 1. Approved 25/04/2022, London – City & East Research Ethics Committee (Bristol Research Ethics Committee Centre, Whitefriars, Level 3, Block B, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8171; cityandeast.rec@hra.nhs.uk), ref: 22/PR/0389 2. Approved 25/04/2022, HRA and Health and Care Research Wales (HCRW, Castlebridge 4, 15 - 19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)29 2023 0457; approvals@hra.nhs.uk), ref: 310149 |
| Health condition(s) or problem(s) studied | Children with learning disabilities and behaviours that challenge |
| Intervention | In Work Package 2.1, the researchers will recruit 15 services representing five service models (as identified in Stage 1 of the MELD Study) and 244 children and carers to take part in an observational study. Outcome measures assessing child behaviours that challenge, child mental health, child health, child quality of life, and adaptive skills, family carer wellbeing, family carer quality of life, services received, and (follow-up only) family carer experience and satisfaction will be completed by family carers at baseline (referral or re-referral to the service) and 12-month follow-up. Each service will also complete a service-level data collection proforma about key elements of their service (including reach, mean time to treatment, mean time to discharge, take-up of services, costs). The researchers will ask external stakeholders (e.g., social worker, education professional, referrer) to complete a satisfaction with the service measure about one child who is being supported by the service who they are involved with in a professional capacity. Statistical analyses will examine 12-month outcomes across service models, accounting for baseline scores and potential confounders or other key factors (informed by stakeholder consultation). Health economic analyses will examine the costs and cost-effectiveness of each service model. In Work Package 2.2a, the researchers will use a multiple case study design approach, and will select one service of each service model type within which to gather data through a review of any relevant documentation and interviews (per case study) with 6-7 children with learning disabilities, 4-5 family carers, 2-3 service staff, 2-3 external staff who are involved in the cases, and a key commissioner. In Work Package 2.2b, with input from the family carer advisory group, professionals advisory group, and SMG members, the researchers will also select up to four case studies to examine coproduction of services with children and/or family carers; again reviewing any relevant documentation and interviewing 4-5 children, 4-5 family carers, 4-5 staff (internal or external) working with co-production, and 2-3 external staff who are involved in the cases. Cross-case comparison and synthesis with documentary evidence about each service/coproduction model (and synthesis with quantitative data about each service from Stage 1) will be used to examine experiences, perceptions, and processes. |
| Intervention type | Other |
| Primary outcome measure | Child-related outcomes (all completed by family carers): Child behaviours that challenge measured using the Behaviour Problems Inventory Short Form (BPI-S) at baseline and 12 months post-referral |
| Secondary outcome measures | Child-related outcomes (all completed by family carers): 1. Child physical health is measured using the Children’s sleep habit questionnaire (CSHQ) and non-communicating children’s pain checklist – revised (NCCPC-R) at baseline and 12 months post-referral 2. Child mental health is measured using the Strengths and Difficulties Questionnaire (SDQ) at baseline and 12 months post-referral 3. Child quality of life is measured using the EQ-5D-Y Health Questionnaire at baseline and 12 months post-referral and either Paediatric Quality of Life Inventory (PedsQL) infant scales (only for children aged 0-24months) or Paediatric Quality of Life Inventory (PedsQL) Generic Core Scales (only for children aged 2+ years) at baseline and 12 months post-referral. 4. Child skills are measured using GO4KIDDS at baseline and 12 months post-referral. 5. Child services received are measured using the Client Service Receipt Inventory (CSRI) at baseline and 12 months post-referral Family carer related outcomes (all completed by family carers): 1. Family carer quality of life is measured using the EQ-5D-5L Health Questionnaire at baseline and 12 months post-referral 2. Family carer wellbeing is measured using Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline and 12 months post-referral 3. Family carer services received are measured using Client service receipt inventory (CSRI) at baseline and 12 months post-referral 4. Family carer experience/satisfaction with service is measured using the Experience of service questionnaire (ESQ) satisfaction with care items at 12 months post-referral Service-level outcomes (completed by services using standard proforma): 1. ‘Reach’ to population at 12 months post-referral 2. Timings of service delivery (e.g., mean time to start support from referral, and length of time to discharge) at 12 months post-referral 3. Service take-up at 12 months post-referral 4. Costs at service level at 12 months post-referral Other-stakeholder-related outcomes (completed by external stakeholders): 1. Satisfaction of external stakeholders (e.g., referrer, health, social-care, or education professionals) brief measure (developed for the purposes of this study) at 12 months post-referral |
| Overall study start date | 01/02/2021 |
| Completion date | 31/07/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 524; UK Sample Size: 524 |
| Key inclusion criteria | The inclusion criteria for services are: 1. They were a service included in the analysis for Stage 1 of the MELD study 2. Nothing significant has changed in their service model since the Stage 1 analysis The inclusion criteria for children referred/referred to services included in Stage 2 of the MELD Study are: 1. Child (0-15 years of age) has learning disabilities as defined administratively or otherwise by the service 2. Child has been referred at least in part for support in relation to behaviours that challenge (including those referred to the relevant learning disability/behaviours that challenge pathway in any broader service) 3. Child’s parental caregiver consents to take part in the research 4. Child’s parental caregiver is able to complete, by questionnaire or interview with a researcher, study outcome measures in English For the case studies, children and young people who will be interviewed will be between 6 and 15 years of age. Consent from their parental caregiver will be obtained before they take part. |
| Key exclusion criteria | The exclusion criteria for services are: 1. Services that have been established for less than one year, and so have had little chance to become reasonably stable within the current study timeframe 2. Services that have a typical referral/re-referral rate over 6 months of fewer than 10 children 3. Services that indicate at Stage 1 of the MELD Study they would not wish to be contacted about involvement in Stage 2 4. Co-applicants Lovell and Liew’s services – to address potential conflicts of interest |
| Date of first enrolment | 01/07/2022 |
| Date of final enrolment | 31/05/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
Hospital/treatment centre
University House
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)24 765 75733 |
|---|---|
| sponsorship@warwick.ac.uk | |
| Website | http://www2.warwick.ac.uk/ |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned outputs from the MELD study will include open-access peer-reviewed journal articles in international academic journals, presentations at national and international academic conferences, and at public engagement/dissemination events. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to research ethics restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.2 | 25/05/2022 | 06/07/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | 04/12/2023 | 05/12/2023 | Yes | No |
Additional files
Editorial Notes
02/07/2025: Contact details updated.
16/06/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/07/2025 to 31/05/2026.
2. The overall end date was changed from 30/09/2025 to 31/07/2026.
3. The plain English summary was updated to reflect these changes.
13/05/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/12/2023 to 31/07/2025.
2. The overall study end date was changed from 31/05/2024 to 30/09/2025.
3. The intention to publish date was changed from 31/12/2024 to 31/12/2025.
05/12/2023: Publication reference added.
10/05/2023: The recruitment end date was changed from 31/05/2023 to 31/12/2023.
12/12/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2023 to 31/05/2024.
2. The recruitment end date was changed from 31/12/2022 to 31/05/2023.
3. The participant level data sharing statement was added.
06/07/2022: Uploaded protocol (not peer reviewed).
10/05/2022: Trial's existence confirmed by the NIHR.
