New parent group intervention to Manage Repetitive Behaviours in young children with autism spectrum disorder (ASD)

ISRCTN	ISRCTN88687420
DOI	https://doi.org/10.1186/ISRCTN88687420
Secondary identifying numbers	11829

Submission date: 11/06/2012
Registration date: 11/06/2012
Last edited: 26/08/2016

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

Plain English summary of protocol

Background and study aims
Repetitive behaviours (RBs) are a core feature of autism spectrum disorder (ASD). These RBs can cause significant social impairment and distress for the individual and their family, interfere with learning and decrease the likelihood of positive interaction and acquisition of new skills. There is no parent group based intervention targeting RBs for young children with ASD. Most early ASD parent groups focus on social communication skills. We have developed with parents and professionals a new parent-based group intervention that focuses on identification, understanding and management of RBs in young children.

The short-term aim is to conduct a study of our new parent group intervention to help parents understand and manage their childs RBs. This study will inform the design of a larger study and help us identify what level of treatment is required to maximise benefits to individual children with ASD. The long-term objective is to enable parents to have a better understanding of why children with ASD may show several RBs, and manage those behaviours which cause difficulty for the family.

Who can participate?
We will recruit 36 parents of young children with autism, ASD or Asperger syndrome, aged 3 to 8 years, who show several RBs.

What does the study involve?
Participating families will be randomly allocated to either the intervention group or the control group. Families in the intervention group will be contacted by the study team to arrange attending the parent group sessions. They will remain under the overall clinical responsibility of local teams and should continue to receive their existing routine care while the group intervention is taking place. Families in the control group will remain under overall clinical care of local teams and should continue to receive their existing routine care. Families in both arms of the trial will receive research assessments at baseline, and after 10, 18 and 24 weeks. If possible we would ask that any medication taken by the child is kept at the same level (i.e., until after the final study assessments have been completed).

What are the possible benefits and risks of participating?
This group course has been shown to be helpful in our preliminary development study. This new study will indicate how feasible and acceptable the Managing Repetitive Behaviour groups are, as well as suggesting how much change occurs in parents confidence and childrens behaviour. We do not think there are any disadvantages or risks if you participate in this study. The questionnaires ask about everyday behaviours of your child, so we do not anticipate that this will cause any problem for you. All travel expenses for attending assessments and group sessions will be reimbursed.

Where is the study run from?
Parent groups will be based in the North East of England (UK)

When is study starting and how long is it expected to run for?
February 2012 to February 2014

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Vicki Grahame
Victoria.Grahame@ntw.nhs.uk

Contact information

Dr Victoria Grahame
Scientific

Complex Neurodevelopmental Disorders Service
Walkergate Park Centre
Benfield Road
Newcastle
NE6 4QD
United Kingdom

Email	Victoria.grahame@ntw.nhs.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Pilot randomised trial of a new parent group intervention to Manage Repetitive Behaviours in young children with autism spectrum disorder (ASD)
Study acronym	MRB
Study objectives	This study is a feasibility and acceptability randomised controlled trial (RCT) of a parent group intervention to manage repetitive behaviours in young children with ASD. Parents are randomly allocated to intervention or to a waiting list control. It is hoped that by increasing parents' confidence and knowledge of strategies the impact of RBs on the child and family willl be reduced.
Ethics approval(s)	NHS Health Reserach Authority: NRES Committee North East - Newcastle & North Tyneside 1, First MREC approval date 09/12/2011, ref: 11/NE/0379
Health condition(s) or problem(s) studied	Topic: Mental Health Research Network; Subtopic: Autism spectrum disorders; Disease: Autism spectrum disorders
Intervention	Parents are randomly allocated to intervention or to a waiting list control. MRB, Acceptability and feasibility pilot RCT to help parents understand and manage repetitive behaviours in young children with ASD. 8 week manualised parent group intervention. Each session lasting 2 hours per session run by experienced specialist early years teacher and a co-therapist. Follow Up Length: 6 month(s)
Intervention type	Other
Primary outcome measure	Target Repetitive Behaviour Vignette; Timepoint(s): Baseline, end of intervention, 18 weeks and 24 weeks
Secondary outcome measures	1. 10min Parent-Child Interaction in Play; Timepoint(s): Baseline, end of intervention, 18 and 24 weeks follow-up 2. Clinical Global Index of Improvement (CGI-I); Timepoint(s): 18 weeks and 24 weeks 3. Repetitive Behaviours Questionnaire (RBQ2); Timepoint(s): RBQ 2 completed by the parent and teacher. Baseline, end of intervention, 18 and 24 weeks follow-up 4. The Parental Self-Efficacy scale; Timepoint(s): Baseline, end of intervention, 18 and 24 weeks follow-up
Overall study start date	10/02/2012
Completion date	01/02/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Upper age limit	8 Years
Sex	Both
Target number of participants	Planned Sample Size: 36; UK Sample Size: 36; Description: 36 young children with ASD aged 3-8 years
Key inclusion criteria	1. Child aged 3 to 8 years old with a diagnosis of ASD 2. Parent sufficient spoken English to take part in assessments and groups 3. Agree not to try other new interventions while involved in study 4. Target Gender: Male & Female; Upper Age Limit 8 years ; Lower Age Limit 3 years
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	10/02/2012
Date of final enrolment	01/02/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Complex Neurodevelopmental Disorders Service

Newcastle
NE6 4QD
United Kingdom

Sponsor information

Northumberland, Tyne and Wear NHS Foundation Trust (UK)
Charity

Complex Neurodevelopmental Disorders Service
Walkergate Park Centre Benfield Road
Newcastle
NE6 4QD
United Kingdom

"ROR"	https://ror.org/01ajv0n48

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Grant Codes: PB-PG-1010-23305

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2015		Yes	No

Editorial Notes

26/08/2016: Publication reference added.