Autism Mental and Behavioural Disorders Developmental disorders - Autism
Conditions
Interventions
Participants are randomly allocated using a cluster randomisation process by participating school. The rationale for this design is due to the group based nature of the therapeutic intervention and to
Sponsors
Leeds and York Partnership NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children: 1. Is aged between 7 and 15 years (based on previous research and extensive PPI recommendations) 2. Attends a mainstream school in years 2-10 3. The child and parent/ guardian have a sufficient understanding of English to be able to provide informed consent and read the LEGO®-based therapy instructions 4. Has an ASD clinical diagnosis from a qualified assessing clinician or team [based on best-practice guidance leading to an ICD-10 (World Health Organization, 1993) or DSM-IV diagnosis (American Psychiatric Association, 2000)] as reported by the child’s parent/ guardian and in the child’s school records (this may include the school’s special educational needs (SEN) register, an individual education plan (IEP), individual health care plan, my support plan (MSPs), education health care plans (EHCPs), individual learning plans (ILP’s) or equivalent) 5. Scores 15 or higher on the Social Communication Questionnaire 6. Has the ability to follow and understand simple instructions (as determined by the associated teacher/ TA or parent/ guardian) Schools: 1. It is a mainstream school located in Leeds, York, or Sheffield 2. It has not used LEGO®-based therapy with the child in the current or preceding school term 3. They have at least one child diagnosed with ASD (in line with child inclusion criteria above)
Exclusion criteria
Exclusion criteria: 1. The school has used LEGO®-based therapy with the child in the current or preceding school term 2. They have physical impairments which would prevent them participating in the activities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Social and emotional competence (including perceived social skills, challenging behaviours and academic confidence) is measured using the Social Skills Improvement System (SSIS) (completed by the teacher) at 16 weeks Updated 04/05/2018: Measured at 20 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Perceived social isolation is measured using Multidimensional Scale of Perceived Social Support (8 items relating to support from friend) (completed by the child) at 16 and 52 weeks 2. Perceived social support from family, friends and significant others is measured using Asher Loneliness Scale (completed by the child) at 16 and 52 weeks 3. Health related quality of life is measured using Child Health Utility 9D scale at 16 and 52 weeks 4. Eligibility is measured using social communication questionnaire (completed by parents) at – The SCQ will be completed by parents as an eligibility check prior to baseline assessment. 5. Social and emotional competence (including perceived social skills, challenging behaviours and academic confidence) is measured using the Social Skills Improvement System (completed by parents) at 16 and 52 weeks 6. The child’s emotional and behavioural difficulties, distress and social impairment is measured using the Strengths and Difficulties Questionnaire (completed by parents) at 16 and 52 weeks 7. Cost effectiveness is measured using a bespoke resource use questionnaire (completed by parents) at 16 and 52 weeks 8. Safety is measured using a bespoke adverse events questionnaire (completed by parents) at 16 weeks 9. Health-related quality of life is measured using the EQ-5DY (3L proxy) (completed by parents) at 16 and 52 weeks 10. Acceptability of the intervention is measured using a bespoke acceptability questionnaire (completed by parents in the intervention arm) at 16 weeks 11. The child’s emotional and behavioural difficulties, distress and social impairment is measured using the Strengths and Difficulties Questionnaire (completed by teachers) at 16 and 52 weeks 12. Cost effectiveness is measured using a bespoke resource use questionnaire (completed by teachers) at 16 and 52 weeks 13. Safety is measured using a bespoke adverse events questionnaire (completed by teachers) at 16 weeks 14. Social and emotional competence (including perce | — |
Countries
England, United Kingdom
Contacts
Public ContactEllen Kingsley
Outcome results
None listed