Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000068460
Ethics application status
Approved
Date submitted
20/12/2015
Date registered
21/01/2016
Date last updated
21/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing Negative Behaviours in Daily Routines for Young Children with Autism
Scientific title
Reducing Negative Behaviours in Daily Routines for Young Children with Autism
Secondary ID [1] 288082 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 296948 0
Global developmental delay 296949 0
Condition category
Condition code
Neurological 297191 297191 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary intervention drew on sensory integration theory (Bundy, Lane, & Murray, 2002). Five components built on an approach adapted from Anzalone and Williamson (2000) were considered as follows with a hypothetical example : 1) Observing and reframing sensory processing challenges in context (e.g., the child has an extreme reaction to the vacuum cleaner due to auditory over-responsiveness). The mother and the therapist, together, observed and discussed the behavior and developed management strategies. 2) Modifying the environment to reduce contributing sensory input (e.g., close doors to place a barrier between the child and the vacuum cleaner). 3) Modifying the activity to minimize unpleasant sensations (e.g., vacuum when the child is not home). 4) Managing the activity (e.g., use visuals to prepare for vacuuming; use calming sensory activities). 5) Promoting agency in the child in response to sensory challenges (e.g., teach the child to turn on a favorite TV show during vacuuming)..Four sessions occurred in the home for an hour once a week at a convenient time nominated by the family. The mother was the focus of the intervention, discussing intervention strategies and how they could be applied in the context of family routines. Sessions occurred over a four week period, however final scheduling was responsive to family needs.
A second intervention was provided to all participants based on the “Being Responsive” (Braithwaite, Keen, & Rodger, 2004) program. The program outlines four roles and six strategies to promote responsiveness and encourage interaction that are common in autism early intervention programmes (Roberts and Prior, 2006) . In this study, the program was modified, identifying and applying specific roles and strategies to manage the target behaviour of concern. The four intervention sessions occurred in the home, with the mother the focus of intervention in coaching/consultation model. The focus of the sessions were to identify how to apply strategies to increase responsiveness in the context of family routines. The mother applied the strategies identified with the child in the main, with some modelling or demonstration by the therapist as needed.
A fidelity checklist was completed by an independent rater, unfamiliar with the study. The rater completed the checklist after listening to a randomly selected audio recording of one session for each participant.
Two weeks break occurred between the two interventions which were randomly allocated to order of intervention for each participant.
Intervention code [1] 293393 0
Behaviour
Comparator / control treatment
Being Responsive is the comparator intervention.
Control group
Active

Outcomes
Primary outcome [1] 296796 0
An individualized VAS was developed for each participant to rate behaviors that interfered with family routines that could be linked with sensory processing challenges. The VAS was programmed into an electronic handheld device (Palm Z22) using The Experience Sampling Program (ESP, Barrett & Barrett, 2005). Mothers received training with the Palm and were encouraged to find a suitable time to rate their perceptions of the child’s behavior each day. The VAS was anchored at both ends by statements relevant to the target behavior; specific criteria describing the target behavior were displayed each time the VAS was opened. The language and phrasing of these descriptors was developed collaboratively with the mothers to ensure focus on the same behavior over time. Mothers moved a slider along the VAS to reflect their perceptions of the behavior over the whole day generating a score out of 100.
Timepoint [1] 296796 0
The primary outcome was measured repeatedly over the baseline and intervention phases of the study, consistent with single case experimental design methodology. Mothers were asked to rate behaviour and their stress on a daily basis during the active phases of the study.
Secondary outcome [1] 319377 0
Developmental Behaviour Checklist (DBC)
Timepoint [1] 319377 0
Three months after completion of intervention phases.
Secondary outcome [2] 319378 0
Parenting Stress Index (PSI)
Timepoint [2] 319378 0
Three months after completion of intervention phases
Secondary outcome [3] 320082 0
Parent stress rated on a Visual Analogue Scale on a daily basis.
Timepoint [3] 320082 0
3 months after intervention was completed

Eligibility
Key inclusion criteria
staff provided study information to parents of children newly diagnosed with ASD. Families were assessed on entry to the study and included if their child was between 3 and 5 years of age and had: (1) atypical sensory processing on the Infant Toddler Sensory Profile (ITSP, Dunn, 2002); (2) a behavior, nominated by the family that interfered with daily routines that was logically linked with sensory challenges (judged by the therapist); (3) autistic disorder based on scores on the Autism Diagnostic Observation Schedule(Lord, Rutter, & Le Couteur, 1995) administered by a psychologist trained to research reliability level; and (4) global developmental delay confirmed by clinic reports provided by parents.
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No autism diagnosis;
Older than 5 years of age;
Parents unable to identify behaviour of concern
No atypical sensory processing

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to order of intervention was concealed from the families and the therapists. On confirmation of meeting the entry criteria, an independent researcher allocated to order of intervention using a random number generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator was used for sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Visual analysis of graphed repeated measures data from visual analogue scale outcome measure. Single case experimental design standards recommend 3 replications of a functional relationship between the introduction of intervention and behaviour change. Based on this requirement a minimum of 3 participants were required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/04/2010
Date of last participant enrolment
Anticipated
Actual
11/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4854 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 4855 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 12354 0
2010 - Surry Hills
Recruitment postcode(s) [2] 12355 0
2135 - Strathfield
Recruitment postcode(s) [3] 12356 0
2204 - Marrickville
Recruitment postcode(s) [4] 12357 0
2035 - Maroubra
Recruitment postcode(s) [5] 12358 0
2193 - Hurlstone Park
Recruitment postcode(s) [6] 12359 0
2207 - Bexley
Recruitment postcode(s) [7] 12360 0
2218 - Carlton

Funding & Sponsors
Funding source category [1] 292510 0
Self funded/Unfunded
Name [1] 292510 0
Not applicable
Country [1] 292510 0
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Health Sciences,
Cumberland Campus,
East St
Lidcombe, NSW 2141
Country
Australia
Secondary sponsor category [1] 291219 0
None
Name [1] 291219 0
Address [1] 291219 0
Country [1] 291219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293985 0
The Childrens Hospital Westmead
Ethics committee address [1] 293985 0
Cnr Hawkesbury Rd and Hainsworth St,
Westmead, NSW 2145
Ethics committee country [1] 293985 0
Australia
Date submitted for ethics approval [1] 293985 0
26/06/2008
Approval date [1] 293985 0
12/12/2008
Ethics approval number [1] 293985 0
08/CHW/58

Summary
Brief summary
The project will explore the efficacy of an occupational therapy intervention in common use clinically with young children with autism, provided in the home to address a problematic behaviour indentified by the family. Two different interventions will be provided to each child in random order, one a sensory based intervention and the other is a relationship based intervention, Being Responsive. Ten participants will be included in a single case experimental design study, undergoing intervention and baseline phases over a 14 week period with daily behaviour ratings and parent stress levels monitored on a visual analogue scale. Each participant acts as their own comparison across phases. This study will help to understand the responses to each intervention. A follow up data collection will occur for two weeks, 6 months after the completion of the intervention. Intervention sessions will be audio recorded to allow for checking of the application of the intervention.
Trial website
Nil
Trial related presentations / publications
Bulkeley, K., Bundy, A., Roberts, J., & Einfeld, S. (2013). ASD intervention research in real world contexts: Refining single case designs. Research in Autism Spectrum Disorders(7), pp. 1257-1264. doi:10.1016/j.rasd.2013.07.014
Public notes
Attachments [1] 669 669 0 0
/AnzctrAttachments/369736-MainStudyEthicsApprovals2008-09.pdf

Contacts
Principal investigator
Name 62002 0
Prof Anita Bundy
Address 62002 0
Faculty of Health Sciences,
The University of Sydney,
Cumberland Campus,
East St.
Lidcombe,
NSW 2141
Country 62002 0
Australia
Phone 62002 0
+61 2 9351 9857
Fax 62002 0
Email 62002 0
[email protected]
Contact person for public queries
Name 62003 0
Ms Kim Bulkeley
Address 62003 0
Faculty of Health Sciences,
The University of Sydney,
Cumberland Campus,
East St.
Lidcombe,
NSW 2141
Country 62003 0
Australia
Phone 62003 0
+61 2 93519034
Fax 62003 0
Email 62003 0
[email protected]
Contact person for scientific queries
Name 62004 0
Ms Kim Bulkeley
Address 62004 0
Faculty of Health Sciences,
The University of Sydney,
Cumberland Campus,
East St.
Lidcombe,
NSW 2141
Country 62004 0
Australia
Phone 62004 0
+61 2 9351 9034
Fax 62004 0
Email 62004 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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