Improving mental health outcomes for adolescents with learning disabilities: a home-base intervention study
ISRCTN | ISRCTN85013504 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN85013504 |
IRAS number | 299406 |
Secondary identifying numbers | IRAS 299406, CPMS 50357 |
- Submission date
- 30/07/2021
- Registration date
- 20/09/2021
- Last edited
- 24/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Some Individuals with learning disability demonstrate some behaviours that are difficult to manage. Staff in special schools may have techniques to help manage these challenges, but children and adolescents spend most of their time at home and often these strategies are not directly taught to parents. Currently, most interventions to manage behavior that challenges are provided in schools, although those children and adolescents spend only a third of their time in school. Parents are rarely involved in interventions and generalisation to the home situation is very limited. The focus of the proposed study is on helping parents of adolescents with intellectual disabilities (with or without autism) to manage concerning behaviors through home-based interventions. Working with a therapist, parents will establish some goals and strategies to resolve problems they experience with their child. our aim is to provide additional support outside the school environment teaching home-based interventions for parents for this population.
Who can participate?
Families who have a child with learning disabilities with or without autism aged between 11 and 19 years old.
What does the study involve?
Firstly parents will complete a few questionnaires. The questionnaires include questions regarding the child's behaviour and some questions about the particiapnt's home that are relevant to our study. These questionnaires will be used to help us understand the participant's profile of strengths and difficulties. Some questionnaires will help us measure any changes in the participant's behavior or skills during the time they are involved in the study. Then, one of our therapists will visit the participant's home to learn about their behaviour or skills and decide together with the parents what they would like to work on at home. We estimate that interventions could last between 4 to 12 weeks.
What are the possible benefits and risks of participating?
All families in this study will have direct contact with a therapist teaching them to manage behaviours that challenge or develop their child's functional skills at home. At this stage of the study, we do not know whether the home-based interventions will be helpful but we hope that we will learn information about how to test this properly.
Where is the study run from?
Evelina London Children's Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2021 to May 2023
Who is funding the study?
Guy's and St Thomas' Charity (UK)
Who is the main contact?
Dr Michael Absoud, Michael.Absoud@gstt.nhs.uk
Contact information
Scientific
Evelina London Children's Hospital
Children's Neurosciences Centre Newcomen Centre
St Thomas' Hospital
Floor 2, Becket House
London
SE1 7EU
United Kingdom
Phone | +44 (0)2071887188 |
---|---|
michael.absoud@gstt.nhs.uk |
Scientific
Evelina London Children's Hospital
Children's Neurosciences Centre Newcomen Centre
St Thomas' Hospital
Floor 2, Becket House
London
SE1 7EH
United Kingdom
Phone | +44 (0)2071887188 |
---|---|
Vicky.Slonims@gstt.nhs.uk |
Study information
Study design | Single-centre interventional |
---|---|
Primary study design | Interventional |
Secondary study design | Non randomised study |
Study setting(s) | Home |
Study type | Quality of life |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
Scientific title | AdolesCents Home based InterVEntion Study |
Study acronym | ACHIEVE |
Study objectives | Adolescents with intellectual disabilities (with or without autism) can present with behavior that challenges and/or a mental health condition (such as depression, anxiety, obsessive-compulsive disorder). Currently, most interventions to manage behavior that challenges are provided in schools, although those children and adolescents spend only a third of their time in school. Parents are rarely involved in interventions and generalisation to the home situation is very limited. The focus of the proposed study is on helping parents of adolescents with intellectual disabilities (with or without autism) to manage concerning behaviors through home-based interventions. Our aim is to assess the feasibility and acceptability of teaching home-based interventions for parents for this population. We aim to recruit 60 adolescents aged between 11-19 years who attend local (South London) special school provision but who do not currently benefit from the education and therapy interventions at home. |
Ethics approval(s) | Approved 19/10/2021, London - Queen Square Research Ethics Committee (HRA NRES Centre Bristol, 3rd floor, block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8061; queensquare.rec@hra.nhs.uk), ref: 21/LO/0645 |
Health condition(s) or problem(s) studied | Adolescents with intellectual disabilities (with or without autism) |
Intervention | The primary focus of our study is to provide intervention to individuals with restricted communication, poorly developed functional skills and behaviour that challenges, with parents who are expressing concern about supporting their child at home. This will be delivered by individualised therapy sessions via home-based and video link sessions to families. The sessions will be delivered by the therapists (SLT or OT) and follow similar procedures as face-to-face therapy sessions. The therapists will engage with parents to establish the target areas (up to 3 target areas) to work during the intervention sessions. The number of interventions sessions will depend on the number and the type of target areas. Interventions session will range between 3 to 10 sessions for each family. Parents will share in setting problem-specific targets for their child. Pre-treatment and immediate post-treatment measures of these targets will be made by the therapists using Goal Attainment Scales (GAS) and COPM. |
Intervention type | Behavioural |
Primary outcome measure | Measured pre- and post- intervention: 1. Extent to which patient's individual goals are achieved in the course of intervention measured using Goal Attainment Scaling (GAS) 2. Problematic target areas measured using the COPM in a semi-structured interview |
Secondary outcome measures | At baseline and post-intervention: 1. Demographics measured using a questionnaire designed to collect families' demographic information such as first language, ethnicity background. 2. Stress parents are experiencing and what factors are causing this stress measured using the Autism Parent Stress Index (APSI) 3. Mental health and problematic/risky behaviours measured using the Assessment of Concerning Behaviour Scale (ACB) 4. Behavioural and emotional problems measured using the Developmental Behaviour Checklist (DBC) 5. Personal, social and health service resource usage measured using the Child and Adolescent Service Use Schedule (CA-SUS) |
Overall study start date | 30/07/2021 |
Completion date | 01/05/2023 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Mixed |
Lower age limit | 11 Years |
Upper age limit | 19 Years |
Sex | Both |
Target number of participants | 60 |
Key inclusion criteria | 1. Age between 11 and 19 years 2. Clinical diagnosis of learning disabilities with/without autism spectrum disorder 3. Willing to consent to participation and able to engage in intervention at home |
Key exclusion criteria | 1. Parents with reduced levels of spoken and/or understanding of English, which would limit participation 2. Children with current child protection issues |
Date of first enrolment | 22/11/2021 |
Date of final enrolment | 01/04/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Floor 2
Becket House
St Thomas Hospital
London
SE1 7EH
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Office Guy’s & St Thomas’ NHS Foundation Trust
R&D Department
16th Floor, Tower Wing
Great Maze
London
SE1 9RT
England
United Kingdom
Phone | +44 (0)207 1889811 |
---|---|
R&D@gstt.nhs.uk | |
Website | http://www.guysandstthomas.nhs.uk/Home.aspx |
https://ror.org/00j161312 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
- Location
- United Kingdom
Results and Publications
Intention to publish date | 02/04/2024 |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Data sharing statement to be made available at a later date |
Publication and dissemination plan | The results of the research will be targeted for publication in peer-reviewed journals of general and special interest. The study details and anonymised results will also be presented at relevant conferences and academic or educational meetings. |
IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
24/05/2023: Contact details updated.
21/10/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 06/10/2022 to 01/04/2023.
2. The overall end date was changed from 06/05/2023 to 01/05/2023.
07/12/2021: The recruitment start date was changed from 06/10/2021 to 22/11/2021.
20/10/2021: The ethics approval has been added.
01/10/2021: The CPMS number was added to the protocol/serial no. field.
02/08/2021: Trial's existence confirmed by Guy's and St Thomas' Charity.