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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Michael Absoud
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
Email michael.absoud@gstt.nhs.uk
Dr Vicky Slonims
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
Email Vicky.Slonims@gstt.nhs.uk

Study information

Study designSingle-centre interventional
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Home
Study typeQuality of life
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleAdolesCents Home based InterVEntion Study
Study acronymACHIEVE
Study objectivesAdolescents 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) studiedAdolescents with intellectual disabilities (with or without autism)
InterventionThe 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 typeBehavioural
Primary outcome measureMeasured 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 measuresAt 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 date30/07/2021
Completion date01/05/2023

Eligibility

Participant type(s)Patient
Age groupMixed
Lower age limit11 Years
Upper age limit19 Years
SexBoth
Target number of participants60
Key inclusion criteria1. 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 criteria1. 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 enrolment22/11/2021
Date of final enrolment01/04/2023

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Evelina Children's Hospital
Newcomen Centre at St Thomas
Floor 2
Becket House
St Thomas Hospital
London
SE1 7EH
United Kingdom

Sponsor information

Guy's and St Thomas' NHS Foundation Trust
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
Email R&D@gstt.nhs.uk
Website http://www.guysandstthomas.nhs.uk/Home.aspx
ROR logo "ROR" https://ror.org/00j161312

Funders

Funder type

Charity

Guy's and St Thomas' 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 date02/04/2024
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe 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 planThe 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.