An evaluation of LEGO-based therapy in school for children with autism

INTERVENTION: 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 control for contamination within schools. Randomisation occurs after eligibility has been established, consent has been obtained and baseline measures collected from teachers/teaching assistants. Intervention arm: Participants receive LEGO‐based therapy. LEGO®‐based therapy is a social skills based therapy that is specifically designed to make social interactions interesting to a child with autism. Children allocated to the intervention attend a weekly LEGO®‐based therapy group for 12 weeks. The primary follow‐up point is 16 weeks after baseline measures are collected. The secondary follow‐up point is 52 weeks after baseline measures are collected. Control arm: Participants receive support as usual from their GPs, mental health and education professionals. Children allocated to the comparator arm will continue receiving support as usual for 12 weeks. The primary follow‐up point is 16 weeks after baseline measures are collected. The secondary follow‐up point is 52 weeks after baseline measures are collected. The Social Skills Improvement System (SSIS) is completed on behalf of each child (in both groups) by teachers and change in these scores will be the main consideration of this research. The Asher loneliness scale, and a number of quality of life questionnaires are also completed. For each child and changes in these are also be examined. All these measures are completed as soon as the child agrees to take part in the research, 16 weeks after this point and again in the next school year. This is done to see if LEGO‐based therapy makes any difference compared to usual care and whether any differences last into the next school year. A small number of interviews with participants about the acceptability of the intervention are completed. CONDITION: Specialty: Mental Health, Primary sub‐specialty: Developmental disorders ‐ Autism; UKCRC code/ Disease: Mental Health/ Disorders of psychological development ; Mental and Behavioural Disorders ; Developmental disorders ‐ Autism PRIMARY OUTCOME: 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 OUTCOME: 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 perceived social skills, challenging behaviours and academic confidence) is measured using Social Skills Improvement System (SSIS) (completed by the teacher) at 52 weeks 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