Managing repetitive behaviours parent group study
| ISRCTN | ISRCTN15550611 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15550611 |
| Secondary identifying numbers | 39269; HTA 16/111/95 |
- Submission date
- 06/08/2018
- Registration date
- 07/08/2018
- Last edited
- 03/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Managing Repetitive Behaviours (MRB) is an eight-session parent-mediated group intervention for parents of young children (aged 3-9 years & 11 months) with a diagnosis of Autism Spectrum Disorder. MRB aims to support parent to develop an understanding of the form and potential function of their child’s challenging Restrictive Repetitive Behaviour (RRB). It also aims to support parents to develop effective strategies to improve the management of their child’s challenging RRB in order to reduce the negative impact of these behaviours on child, parent and family functioning. Functional analysis principles will help parents to understand where and how to intervene and to develop alternative strategies and techniques to manage their child’s negative experiences across a range of everyday contexts. The programme is delivered in eight two-hour sessions using a manualised programme which builds systematically on prior learning. This study aims to evaluate the clinical and cost effectiveness of MRB compared with Learning About Autism (a psychoeducation parent group, equivalent to current best practice), for the management of challenging RRB in children with ASD.
Who can participate?
Parents/carers aged 18 and over who have a child aged between 3 years and 9 years and 11 months with Autism or Autism Spectrum Disorder
What does the study involve?
Participants are randomly allocated to receive either the MRB intervention or a psychoeducation group (Learning About Autism). Parents are invited to attend eight group sessions with about seven other parents. Each group session lasts two hours and they take place about a week apart. There are breaks during the school holidays. Both the MRB group and the Learning About Autism group give parents the opportunity to meet other parents. Parents are contacted immediately after they complete all eight of the group sessions and then again 24 weeks and 52 weeks later to arrange home visits. During these home visits a member of the research team talks with the parent about their child’s RRB in particular situations and they complete some questionnaires.
What are the possible benefits and risks of participating?
Families who take part in this study will be given an opportunity to contribute to research which will help to improve our understanding of ASD and RRB. Finding out whether the MRB or Learning About Autism groups are effective will help find out which is the most helpful intervention to other families with young children with ASD within early intervention services. The disadvantages or risks of participating in this study are minimal. Parents may find it upsetting to discuss their child’s feelings and reactions. This will be minimised by ensuring that the group is run by experienced professionals who are able to create a safe and supportive environment.
Where is the study run from?
1. Northumberland, Tyne and Wear NHS Foundation Trust (UK)
2. Tees, Esk and Wear Valleys NHS Foundation Trust (UK)
3. NHS Lothian (UK)
When is the study starting and how long is it expected to run for?
April 2018 to March 2022
Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment Programme (UK)
Who is the main contact?
Ayesha Mathias
Ayesha.Mathias@newcastle.ac.uk
Contact information
Scientific
Newcastle Clinical Trials Unit
1-4 Claremont Terrace
Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom
| Phone | +44 (0)191 208 7216 |
|---|---|
| Ayesha.Mathias@newcastle.ac.uk |
Scientific
Chief Investigator
Complex Neurodevelopmental Disorders Service (CNDS)
Walkergate Park
Benfield Road
Newcastle
NE6 4QD
United Kingdom
| Phone | +44 (0)191 287 5260 |
|---|---|
| Victoria.Grahame@ntw.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Education or Self-Management, Psychological & Behavioural, Complex Intervention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Managing repetitive behaviours: a clinical and cost effectiveness trial of a parent group intervention to manage restricted and repetitive behaviours in young children with autism spectrum disorder |
| Study hypothesis | The primary objective of this trial is to evaluate the clinical and cost effectiveness of the Managing Repetitive Behaviours (MRB) parent group intervention compared with Learning About Autism (a psychoeducation parent group, equivalent to current best practice), for the management of challenging RRB in children with ASD. |
| Ethics approval(s) | Approved 20/08/2018, South West – Cornwall and Plymouth Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; Tel: +44 (0)207 104 8033, +44 (0)207 104 8004; Email: nrescommittee.southwest-cornwall-plymouth@nhs.net), REC ref: 18/SW/0173 |
| Condition | Repetitive behaviours in children with autism spectrum disorder |
| Intervention | This is a multicentre, 2 arm randomised control trial with 3 sites across England and Scotland. Patients will be randomised 1:1 to receive either the MRB intervention or psychoeducation group (Learning About Autism) First, potentially eligible parents will be identified and approached by a health professional. If parents are interested in taking part after reading the information sheet, they will be asked to complete the Expression of Interest form (included with the sheet) and hand it to their child’s health professional or post it directly to us via the envelope provided. The parents can contact the research team anytime to have their questions answered. After the trialists have received the expression of Interest form, the parent will be called to discuss the study and answer any further questions they might have. If they are happy to take part, a member of the research team will arrange to meet with them and their child at home (or another place that is easy for them) to answer any questions they have. If the parent decides to take part, they are asked to sign a consent form and to complete some questionnaires. This will take around 1 hour. The trialists will also arrange another visit to see both the parent and child at the university base. At this visit, they will ask the parent to complete some questionnaires and we will do an assessment of communication and social interaction with the child. The visit will take about 1.5 – 2 hours. We will ask if we could approach the child’s teacher so he/she can complete a questionnaire about the child’s repetitive behaviours in the classroom. After the university visit, the parent will be allocated to either the eight week MRB parent group OR the eight week Learning About Autism group run by the National Autistic Society. Which group they are allocated to will be decided randomly by a computer programme, not a member of the research team. Whichever group they are in, the trialists will invite the parent to attend eight group sessions with approximately seven other parents. They would like the same parent to attend each session, but a second, adult family member is welcome to join the group too. Each group session will last two hours and they will take place about a week apart. There will be breaks during the school holidays. Both the MRB group and the Learning About Autism group give parents the opportunity to meet other parents. Regardless of which group the parent is in (either MRB or Learning About Autism), they are contacted immediately after they complete all eight of the group sessions, and then again 24 weeks and 52 weeks later to arrange home visits. During these home visits a member of the research team will talk with the parent about their child’s RRB in particular situations and will ask to complete some questionnaires. |
| Intervention type | Behavioural |
| Primary outcome measure | Improvement or no improvement at 24 weeks, based on the clinical global impression of improvement (CGI-I) |
| Secondary outcome measures | Primary Economic Outcome Measure Cost per additional child achieving at least the target improvement in CGI-I scale will be calculated in each pathway Secondary Child Outcome Measures 1. Restrictive Repetitive Behaviours (RRB), measured using Target Behaviour Vignette at baseline, Week 10, Week 24 and Week 52 2. RRB, measured using Repetitive Behaviour Questionnaire - 2 (RBQ-2) at baseline, Week 10, Week 24 and Week 52 3. RRB, measured using Teacher Repetitive Behaviour Questionnaire 2 (Teacher RBQ-2) at baseline, Week 10, Week 24 and Week 52 4. Adaptive functioning, measured using Vineland Adaptive Behaviour Scales III (VABS III) at baseline and Week 24 Parent Outcome Measures 1. Behaviours typically exhibited by children with ASD, measured using parent self-efficacy questionnaire at baseline, Week 10, Week 24 and Week 52 2. Parenting stress specific to core and co-morbid symptoms of ASD, measured using Autism Parenting Stress Index (APSI) at baseline, Week 10, Week 24 and Week 52 3. Wellbeing, measured using Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline, Week 24 and Week 52 Secondary Family Outcome Measures Autism Family Experience Questionnaire (AFEQ) at baseline, Week 24 and Week 52 Secondary Economic Outcome Measures 1. Healthcare resources which are used by the children, measured using resource use questionnaire at baseline, Week 24 and Week 52. This will be calculated to result in an average cost of services per pathway 2. Costs and time lost to travel, measured using time and travel questionnaire at baseline 3. Health-related quality of life of caregivers reported per child, measured using EQ-5D-5L questionnaire at baseline, Week 24 and Week 52 4. Health-related quality of life of the child with RRB, measured using CHU9D proxy version at baseline, Week 24 and Week 52 Updated 04/04/2019: VABS II changed to VABS III. |
| Overall study start date | 01/04/2018 |
| Overall study end date | 31/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 250; UK Sample Size: 250 |
| Participant inclusion criteria | Current inclusion criteria as of 21/08/2019: Parents/carers aged 18 years and over who: 1. Have a child aged between 3 years and 9 years and 11 months at the time of consent with a clinical diagnosis of Autism or Autism Spectrum Disorder 2. Have sufficient spoken and written English to: 2.1. Provide written informed consent 2.2. Complete the assessments including being able to identify one or more challenging RRB 2.3. Participate in the group-based intervention 3. Are willing to be randomised and attend all the group sessions for the allocated arm of the study 4. Agree to maintain their child’s current medication regime up to 24 weeks (unless change is advised by child’s clinician) 5. Agree not to participate in any other trials while involved in the trial up to 24 weeks Previous inclusion criteria: Parents/carers aged 18 years and over who: 1. Have a child aged between 3 years and 7 years and 11 months at the time of consent with a clinical diagnosis of Autism or Autism Spectrum Disorder 2. Have sufficient spoken and written English to: 2.1. Provide written informed consent 2.2. Complete the assessments including being able to identify one or more challenging RRB 2.3. Participate in the group-based intervention 3. Are willing to be randomised and attend all the group sessions for the allocated arm of the study 4. Agree to maintain their child’s current medication regime 5. Agree not to participate in any other trials while involved in the trial up to 24 weeks |
| Participant exclusion criteria | 1. Parent and child currently taking part in another parent group-based intervention 2. Parent with a current severe learning disability or a severe disabling mental illness that interferes with ability to take part in group-based intervention trial 3. Sibling is taking part in this study |
| Recruitment start date | 01/09/2018 |
| Recruitment end date | 31/05/2020 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Walkergate Park
Benfield Road
Newcastle upon Tyne
NE6 4QD
United Kingdom
Derwentside Child and Family Centre
192 Medomsley Road
Consett
DH8 5HT
United Kingdom
9 Sciennes Rd
Edinburgh
EH9 1LF
United Kingdom
Sponsor information
Hospital/treatment centre
St. Nicholas Hospital
Jubilee Road
Gosforth
Newcastle upon Tyne
NE3 3XT
England
United Kingdom
| Phone | +44 (0)191 246 7221 |
|---|---|
| Lyndsey.Dixon@ntw.nhs.uk | |
"ROR" |
https://ror.org/01ajv0n48 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2022 |
|---|---|
| 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 | Newsletters summarising the progress and findings of the study will be sent to families and local professionals who have taken part in recruitment and supported the study, both during the trial to support retention, and at the end of the study to share findings. The study protocol will be published, and findings will be written up for academic peer reviewed journals (including open access) and presented at relevant national and international conferences. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 01/04/2021 | 03/11/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
03/11/2021: Publication reference added.
12/01/2021: The overall trial end date was changed from 31/07/2021 to 31/03/2022.
10/02/2020: The recruitment end date has been changed from 31/01/2020 to 31/05/2020.
17/10/2019: One of the scientific contacts has been changed and the plain English summary has been updated accordingly.
22/08/2019: Contact details added.
21/08/2019: The following changes were made to the trial record:
1. Ethics approval details and trial website added.
2. Inclusion criteria updated.
04/04/2019: The secondary outcome measures were updated.
28/03/2019: The condition has been changed from "Specialty: Children, Primary sub-specialty: Neurosciences; UKCRC code/ Disease: Mental health/ Disorders of psychological development" to "Repetitive behaviours in children with autism spectrum disorder" following a request from the NIHR.
