Autism spectrum disorder Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Autism diagnosis provided by a detailed clinical history (all of which are obtained as part of routine NHS care). 2. Nonverbal or minimally verbal (lacking communicative speech, or speaking fewer than 100 single words and no phrase speech). 3. Clinical judgement of motor impairment. 4. Receptive language surpasses expressive language. 5. Ages 3 to 15 years old. 6. English is the primary language spoken in the home (as Point OutWords is not yet translated).
Exclusion criteria
Exclusion criteria: 1. Diagnosed with vision or hearing impairment (which would affect interaction with an iPad). 2. Caregiver does not speak English. 3. Diagnosed with severe impairment of motor function (e.g. cerebral palsy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Child measures: 1. Fine Motor skills, Receptive Language and Expressive Language will be assessed using the Mullen Scales of Early Learning pre-intervention, post-intervention, and at a three-month follow-up. 2. Change in autistic behaviours will be measured using the Brief Observation of Social Communication Change (BOSCC) pre-intervention, post-intervention, and at a three-month follow-up. 3. The social interaction between parent and child is measured using the Dyadic Communication Measure for Autism (DCMA) pre-intervention, post-intervention, and at a three-month follow-up (the BOSCC and the DCMA are scored from the same twelve-minute recording of parent-child play). 4. Receptive language will be assessed using the British Picture Vocabulary Scale (BPVS-3) pre-intervention, post-intervention, and at a three-month follow-up. Parent checklists : 5. Social communicative competence will be measured by Social Responsiveness Scale (SRS-2) pre-intervention, post-intervention, and at a three-month follow-up. Assessing feasibility and acceptability: 1. Internal data from the iPad app such as usage time and number of distinct sessions are used to assess fidelity to the intervention regime and are collected during the intervention period. 2. The feasibility and experience of using the app in the context of the daily family life will be explored by asking parents to keep a diary during the intervention period and by holding focus groups after the end of the intervention period. 3. The usability of the app will be explored using two “Think Aloud” sessions conducted during the first and last intervention session where the caregiver will be asked to speak aloud their attitudes towards the app in real time. 4. Acceptability of the intervention to clinicians will be explored through individual interviews | — |
Secondary
| Measure | Time frame |
|---|---|
| Child measures: The Neuromotor integrity of the speech system will be assessed using the Verbal Motor Production Assessment for Children (VMPAC) pre-intervention, post-intervention, and at a 3-month follow-up. The iPad will record the child’s real-time finger movements when they are using Point OutWords for the duration of the intervention period. Changes in manual motor skills will be measured in the following parameters: 1. Visumotor targeting error is measured as the Euclidean (straight-line) distance between the initial point of contact with the screen and the nearest extent of the target puzzle piece. 2. Motor efficiency is measured as variance of linear speed in the direction of motion and angular speed (the rate of change in direction of motion over time). 3. Accuracy in movement will be measured as a ratio of the actual drag path to the shortest possible path length. Parent measures: 1. Stress related to the relationship between parent and child will be measured using the Parenting Stress Index (PSI-4) pre-intervention, post-intervention, and at a three-month follow-up. 2. Communication, daily living skills, socialisation, motor skills, and maladaptive behaviour will be measured using the Vineland Adaptive Behaviour Scales (VABS-2), a parent interview pre-intervention, post-intervention, and at a three-month follow-up. 3. Satisfaction with family life will be measured using the Family Quality of Life Scale (FQoL) pre-intervention, post-intervention, and at a three-month follow-up. 4. Change in autistic behaviour will be measured using the Autism Impact Measure (AIM) pre-intervention, post-intervention, and at a three-month follow-up. | — |
Countries
England, United Kingdom