Efficacy of PEGASUS Clinical Trial
Official title:
Evaluating Psychoeducation for People With Autism Spectrum Disorder
When a clinician gives an autism spectrum disorder (ASD) diagnosis they hope this will be
helpful to the person receiving it and their family. In reality children with an ASD
describe few benefits to receiving this diagnosis - they often report feeling confused and
stigmatised by it. Parents can also struggle to understand their child's diagnosis and
report needing greater support from professionals in this respect (Midence & O'neill, 1999;
Osborne & Reed, 2008).
Little is known about how to help children and families integrate their ASC 'label' in a
positive way. Whilst there is anecdotal evidence that psychoeducation after diagnosis can
help, there has been no formal evaluation of this approach and no evidence-based programmes
of this type are available. In the current study the investigators aim to test empirically a
psychoeducational programme for children with an ASD ('PEGASUS'), using a randomised
controlled design. The investigators aim to evaluate whether this psychological and
educational intervention impacts positively upon understanding of ASC, self-esteem,
functional adaption, well-being and family functioning.
| Status | Not yet recruiting |
| Enrollment | 40 |
| Est. completion date | |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 9 Years to 14 Years |
| Eligibility |
Inclusion Criteria: 1. Received an ASD diagnosis from Child and Adolescent Psychiatrist, Clinical Psychologist or Paediatrician. 2. Aware of ASD diagnosis. 3. Aged between 9 and 14 years. 4. Able to function in group setting, as evidenced in educational context. 5. Speaks English Exclusion Criteria: 1. No generalised Intellectual Disability as indicated by IQ below 65. 2. Not engaged in additional formal psychosocial intervention during study period. 3. Not taking psychiatric medication at baseline assessment, or taking a stable dose of psychiatric medication expected to remain constant throughout study participation. |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Institute of Child Health | London |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Child Health |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Autism Knowledge Questionnaire | All measures taken at baseline, termination of treatment and six months follow-up. | 30 months | No |
| Primary | Child Behaviour Checklist | All measures taken at baseline, termination of treatment and six months follow-up. | 30 months | No |
| Primary | Vineland-II, Rosenburg Self-Esteem Scale | All measures taken at baseline, termination of treatment and six months follow-up. | 30 months | No |
| Primary | Parenting Stress index | All measures taken at baseline, termination of treatment and six months follow-up. | 30 months | No |
| Secondary | Qualitative interview conducted at baseline and termination. | 30 months | No |