A trial of sensory integration therapy versus usual care for sensory processing difficulties in autism spectrum disorder in children

A pragmatic randomised controlled trial of sensory integration therapy versus usual care for sensory processing difficulties in autism spectrum disorder in children: impact on behavioural difficulties, adaptive skills and socialisation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14716440

Enrollment

216

Registered

2016-11-08

Start date

2017-04-01

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder in children aged 4-11 years with sensory processing difficulties. Mental and Behavioural Disorders Autism spectrum disorder

Interventions

Following screening, consent and collection of baseline data, participants will be randomly allocated to usual care or SIT in a 1:1 ratio. Online randomisation will utilise random permuted blocks stra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 14/01/2019: 1. Children aged between 4 and 11 years with ASD/related disorder 2. In mainstream primary education until the primary outcome timepoint 3. Definite/probable SP difficulties 4. Carer consent/child assent Previous inclusion criteria: 1. Children aged between 4 and 11 years with ASD/related disorder 2. In mainstream primary education for the duration of the trial 3. Definite/probable SP difficulties 4. Carer consent/child assent

Exclusion criteria

Exclusion criteria: 1. Current/previous SIT 2. Current Applied Behaviour Analysis therapy

Design outcomes

Primary

Measure	Time frame
Irritability/agitation is measured using the Aberrant Behaviour Checklist (ABC) at baseline, 6 and 12 months.	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 14/01/2019: 1. Other problem behaviour is measured using Aberrant Behaviour Checklist (ABC) subscales at baseline, 6 and 12 months 2. Adaptive behaviours, socialisation and functional change are measured using Vineland Adaptive Behavior Scales (VABS-II) at baseline, 6 and 12 months 3. Carer stress is measured using the Autism Parenting Stress Index (APSI) at baseline, 6 and 12 months 4. Quality of life is measured using the EQ5D and CarerQoL questionnaires at baseline, 6 and 12 months Previous secondary outcome measures: 1. Other problem behaviour is measured using Aberrant Behaviour Checklist (ABC) subscales at baseline, 6 and 12 months 2. Adaptive behaviours and socialisation are measured using Vineland Adaptive Behavior Scales (VABS-II) at baseline, 6 and 12 months 3. Functional change is assessed using the Pediatric Evaluation of Disability Inventory - computer adaptive test (PEDI-CAT) at baseline, 6 and 12 months 4. Carer stress is measured using the Autism Parenting Stress Index (APSI) at baseline, 6 and 12 months 5. Quality of life is measured using the EQ5D and CarerQoL questionnaires at baseline, 6 and 12 months	—

Measure

Time frame

Current secondary outcome measures as of 14/01/2019: 1. Other problem behaviour is measured using Aberrant Behaviour Checklist (ABC) subscales at baseline, 6 and 12 months 2. Adaptive behaviours, socialisation and functional change are measured using Vineland Adaptive Behavior Scales (VABS-II) at baseline, 6 and 12 months 3. Carer stress is measured using the Autism Parenting Stress Index (APSI) at baseline, 6 and 12 months 4. Quality of life is measured using the EQ5D and CarerQoL questionnaires at baseline, 6 and 12 months Previous secondary outcome measures: 1. Other problem behaviour is measured using Aberrant Behaviour Checklist (ABC) subscales at baseline, 6 and 12 months 2. Adaptive behaviours and socialisation are measured using Vineland Adaptive Behavior Scales (VABS-II) at baseline, 6 and 12 months 3. Functional change is assessed using the Pediatric Evaluation of Disability Inventory - computer adaptive test (PEDI-CAT) at baseline, 6 and 12 months 4. Carer stress is measured using the Autism Parenting Stress Index (APSI) at baseline, 6 and 12 months 5. Quality of life is measured using the EQ5D and CarerQoL questionnaires at baseline, 6 and 12 months

—

Countries

United Kingdom, Wales

Contacts

Public ContactElizabeth Randell

randelle@cardiff.ac.uk+44 2920 687608

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026