Condition category
Mental and Behavioural Disorders
Date applied
11/06/2012
Date assigned
11/06/2012
Last edited
26/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 child’s 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 children’s 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Victoria Grahame

ORCID ID

Contact details

Complex Neurodevelopmental Disorders Service
Walkergate Park Centre
Benfield Road
Newcastle
NE6 4QD
United Kingdom
-
Victoria.grahame@ntw.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11829

Study information

Scientific title

Pilot randomised trial of a new parent group intervention to Manage Repetitive Behaviours in young children with autism spectrum disorder (ASD)

Acronym

MRB

Study hypothesis

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

NHS Health Reserach Authority: NRES Committee North East - Newcastle & North Tyneside 1, First MREC approval date 09/12/2011, ref: 11/NE/0379

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

10/02/2012

Overall trial end date

01/02/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 36; UK Sample Size: 36; Description: 36 young children with ASD aged 3-8 years

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

10/02/2012

Recruitment end date

01/02/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Complex Neurodevelopmental Disorders Service
Newcastle
NE6 4QD
United Kingdom

Sponsor information

Organisation

Northumberland, Tyne and Wear NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Charity

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26036646

Publication citations

Additional files

Editorial Notes

26/08/2016: Publication reference added.