ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

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]

Behaviour

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Immediately following end of intervention.

Primary outcome [2]

Change in physiological sensory reactivity measured using electroencephalogram and heart rate variability during a sensory (auditory) oddball paradigm.

Timepoint [2]

Immediately following end of intervention

Primary outcome [3]

Change in clinical sensory reactivity measured using the Sensory Experiences Questionnaire (parent report).

Timepoint [3]

Immediately following end of intervention

Secondary outcome [1]

Change in parent stress and caregiving effort measured using the Parenting Stress Index - Brief Form (parent report).

Timepoint [1]

Immediately following end of intervention.

Secondary outcome [2]

Change in child adaptive behaviour measured using the Strengths and Difficulties Questionnaire (parent report).

Timepoint [2]

Immediately following end of intervention.

Secondary outcome [3]

Change in child anxiety using the Spence Child Anxiety Scale (parent report).

Timepoint [3]

Immediately following end of intervention.

Secondary outcome [4]

Change in caregiving effort measured utilising the Parent Effort Scale (parent report).

Timepoint [4]

Immediately following end of intervention.

Secondary outcome [5]

Primary Outcome: Change in clinical secondary reactivity as measured by the SP3D, a clinician administered sensory evaluation tool.

Timepoint [5]

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

Sex

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

30/04/2018

Actual

Date of last participant enrolment

Anticipated

22/04/2019

Actual

Date of last data collection

Anticipated

19/07/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2308 - Callaghan

Recruitment postcode(s) [2]

2300 - Newcastle

Recruitment postcode(s) [3]

2299 - Lambton

Recruitment postcode(s) [4]

2290 - Charlestown

Recruitment postcode(s) [5]

2280 - Belmont

Recruitment postcode(s) [6]

2315 - Nelson Bay

Recruitment postcode(s) [7]

2325 - Cessnock

Recruitment postcode(s) [8]

2318 - Williamtown

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Hunter Medical Research Institute

Address [1]

Lot 1 Kookaburra Cct
New Lambton Heights NSW 2305

Country [1]

Australia

Primary sponsor type

University

Name

University of Newcastle

Address

University Drive
Callaghan NSW 2308

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

University Drive
Callaghan NSW 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/02/2018

Approval date [1]

Ethics approval number [1]

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

A/Prof Alison Lane

Address

School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 2 4921 5004

Fax

+61 2 4921 7053

alison.lane@newcastle.edu.au

Contact person for public queries

Name

Alison Lane

Address

School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 2 4921 5004

Fax

+61 2 4921 7053

alison.lane@newcastle.edu.au

Contact person for scientific queries

Name

Alison Lane

Address

School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 2 4921 5004

Fax

+61 2 4921 7053

alison.lane@newcastle.edu.au

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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Documents added automatically

No additional documents have been identified.

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