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Trial registered on ANZCTR


Registration number
ACTRN12618000639224p
Ethics application status
Submitted, not yet approved
Date submitted
22/03/2018
Date registered
23/04/2018
Date last updated
23/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Do sensory symptoms impact outcomes of the Alert Program for children with Autism Spectrum Disorder?
Scientific title
The impact of sensory subtype on outcomes of the Alert Program for children with Autism Spectrum Disorder: a feasibility study
Secondary ID [1] 294351 0
Hunter Medical Research Institute G1701354
Universal Trial Number (UTN)
U1111-1210-9854
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 307074 0
Condition category
Condition code
Mental Health 306183 306183 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention (AP) will be provided to all participants. It involves a one-on-one face to face consultation weekly for 1 hour for 10 weeks (10 hours total) to be held in the UON Occupational Therapy Clinic. The occupational therapist, child participant and caregiver will be involved in each session and there will be recommendations for follow up and carry over at home. The AP combines principles of cognitive behavioural therapy and sensory integration. The AP is a three-stage active learning program. In Stage 1, an engine analogy is used to explain the concepts of arousal and self-regulation (slow engine=low arousal, sluggish feeling; high engine=high arousal, out of control; just right engine= just right arousal for learning, playing, getting along). Stages 2 and 3 introduce and implement the concept of ‘sensory diet’, where the sensory environment and specific child sensory needs are considered in optimising child arousal and regulation for the activity and environment. Usefulness of the AP has been documented with preschool through early adolescent aged children. Sensory diets are commonly used with children by occupational therapists and are endorsed for use with children with ASD by the American Occupational Therapy Association. AP has been shown effective in improving self-regulation and behaviour in children with emotional disturbance. Sessions will be conducted by a qualified occupational therapist blinded to the sensory subtype of the child. Intervention sessions will be videoed for the purposes of review of intervention fidelity. The occupational therapist will keep session notes after each session detailing attendance, content of the session, child progress and adherence to home activities.
Intervention code [1] 300660 0
Behaviour
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305198 0
Change in child self-regulation measured using Goal Attainment Scaling following parent interview. The Goal Attainment Scaling interview will be completed by a registered occupational therapist blind to the participant's sensory subtype.
Timepoint [1] 305198 0
Immediately following end of intervention.
Primary outcome [2] 305199 0
Change in physiological sensory reactivity measured using electroencephalogram and heart rate variability during a sensory (auditory) oddball paradigm.
Timepoint [2] 305199 0
Immediately following end of intervention
Primary outcome [3] 305200 0
Change in clinical sensory reactivity measured using the Sensory Experiences Questionnaire (parent report).
Timepoint [3] 305200 0
Immediately following end of intervention
Secondary outcome [1] 344480 0
Change in parent stress and caregiving effort measured using the Parenting Stress Index - Brief Form (parent report).
Timepoint [1] 344480 0
Immediately following end of intervention.
Secondary outcome [2] 344481 0
Change in child adaptive behaviour measured using the Strengths and Difficulties Questionnaire (parent report).
Timepoint [2] 344481 0
Immediately following end of intervention.
Secondary outcome [3] 344482 0
Change in child anxiety using the Spence Child Anxiety Scale (parent report).
Timepoint [3] 344482 0
Immediately following end of intervention.
Secondary outcome [4] 345235 0
Change in caregiving effort measured utilising the Parent Effort Scale (parent report).
Timepoint [4] 345235 0
Immediately following end of intervention.
Secondary outcome [5] 345955 0
Primary Outcome: Change in clinical secondary reactivity as measured by the SP3D, a clinician administered sensory evaluation tool.
Timepoint [5] 345955 0
Immediately following the end of the intervention.

Eligibility
Key inclusion criteria
Confirmed diagnosis of Autism Spectrum Disorder; can be classified using established methods into either Reactive or MSI sensory subtypes; IQ>70; can attend all study procedures. Caregiver participants must be the parent or legal guardian of a child with ASD who meets the above criteria.
Minimum age
6 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil additional for either child or parent participants.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All participants in the study will receive the AP intervention. Differences in outcomes between groups will be analysed by pre-existing exposures, namely, sensory subtype. Participants will be classified according to their scores in Reactive and MSI sensory subtypes using the Short Sensory Profile (parent report) on entry to the study. A pre-established algorithm developed by the lead CI will be used to determine subtype scores (i.e. Reactive or MSI). Outcome assessors and intervention therapists will be blind to subtype classification.

Pre- and post-test difference scores will be calculated for each outcome variable according to the relevant measurement conventions. These scores will be submitted to analysis using the General Linear Model for repeated measures to assess differences between matched Reactive and MSI pairs. There is insufficient literature to determine a priori power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 22118 0
2308 - Callaghan
Recruitment postcode(s) [2] 22119 0
2300 - Newcastle
Recruitment postcode(s) [3] 22120 0
2299 - Lambton
Recruitment postcode(s) [4] 22122 0
2290 - Charlestown
Recruitment postcode(s) [5] 22123 0
2280 - Belmont
Recruitment postcode(s) [6] 22124 0
2315 - Nelson Bay
Recruitment postcode(s) [7] 22125 0
2325 - Cessnock
Recruitment postcode(s) [8] 22126 0
2318 - Williamtown

Funding & Sponsors
Funding source category [1] 298993 0
Other
Name [1] 298993 0
Hunter Medical Research Institute
Address [1] 298993 0
Lot 1 Kookaburra Cct
New Lambton Heights NSW 2305
Country [1] 298993 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 298272 0
None
Name [1] 298272 0
Address [1] 298272 0
Country [1] 298272 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299923 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 299923 0
University Drive
Callaghan NSW 2308
Ethics committee country [1] 299923 0
Australia
Date submitted for ethics approval [1] 299923 0
02/02/2018
Approval date [1] 299923 0
Ethics approval number [1] 299923 0

Summary
Brief summary
Autism Spectrum Disorder (ASD) affects learning, social participation and daily function across the lifespan. Approximately 35,000 school-aged Australian children live with ASD; 95% of these experience educational restrictions. Available treatments are only moderately successful and are not effective for all children with ASD. Knowledge about what (intervention) is likely to work for whom is missing from the field. Individuals with ASD and their families frequently attribute the significant functional difficulties experienced to sensory symptoms. Sensory symptoms are reflected in behaviours such as hyper-reactivity (e.g. extreme distress in response to an unexpected sound), hypo-reactivity (e.g. failure to respond to a painful stimulus) and unusual sensory interests (e.g. excessive smelling of objects). Sensory symptoms are so common in ASD that they now form one subset of the diagnostic criteria for ASD. Therapies to remediate sensory symptoms are in high demand. In fact, occupational therapy, which is the lead profession providing sensory-directed therapies, is the second most frequently utilised therapy by families of children with ASD. The few controlled studies that examine the efficacy of sensory-directed therapies, however, report inconclusive results. A critical issue limiting previous research in this area is that sensory symptoms have been broadly defined and imprecisely characterised.

Our group has developed a method of classifying children with ASD into clinically meaningful subtypes based on their parent-reported sensory symptoms. We observe that children with ASD can be classified into sensory subtypes that vary on the dimensions of sensory reactivity (regulating the intensity of a response to a given stimulus) and multisensory integration (MSI; simultaneous processing of concurrent sensory modalities). Each sensory subtype has been found to display a distinct pattern of behaviour thus providing a novel basis on which to customize treatments. The primary objective of our study is to assess the relative effectiveness of a sensory regulatory intervention - Alert Program for Self-Regulation (AP) - for children with ASD and their caregivers. The hypothesis for the study is that for all participants, engagement in the AP will result in: 1) achievement of caregiver defined goals in self-regulation, 2) reduced physiological sensory reactivity (EEG & ANS cardiac), 3) reduced clinical sensory reactivity, 3) reduced parent stress and caregiving effort and 4) improved adaptive behaviour and anxiety following participation in the AP. We further hypothesise that participants with a sensory subtype indicating more difficulties with sensory reactivity will demonstrate significantly greater improvements on all measures than matched ASD participants whose sensory subtype indicates difficulties in MSI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81998 0
A/Prof Alison Lane
Address 81998 0
School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308
Country 81998 0
Australia
Phone 81998 0
+61 2 4921 5004
Fax 81998 0
+61 2 4921 7053
Email 81998 0
alison.lane@newcastle.edu.au
Contact person for public queries
Name 81999 0
A/Prof Alison Lane
Address 81999 0
School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308
Country 81999 0
Australia
Phone 81999 0
+61 2 4921 5004
Fax 81999 0
+61 2 4921 7053
Email 81999 0
alison.lane@newcastle.edu.au
Contact person for scientific queries
Name 82000 0
A/Prof Alison Lane
Address 82000 0
School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308
Country 82000 0
Australia
Phone 82000 0
+61 2 4921 5004
Fax 82000 0
+61 2 4921 7053
Email 82000 0
alison.lane@newcastle.edu.au

No data has been provided for results reporting
Summary results
Not applicable