Improving mental health outcomes for adolescents with learning disabilities: a home-base intervention study

ISRCTN	ISRCTN85013504
DOI	https://doi.org/10.1186/ISRCTN85013504
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	299406
Protocol serial number	IRAS 299406, CPMS 50357
Sponsor	Guy's and St Thomas' NHS Foundation Trust
Funder	Guy's and St Thomas' Charity

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

Primary study design	Interventional
Study design	Single-centre interventional
Secondary study design	Non randomised study
Study type	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(s)	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
Key secondary outcome measure(s)	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)
Completion date	01/05/2023

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	11 Years
Upper age limit	19 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Evelina Children's Hospital

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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.