Evaluating PEGASUS - a Group Intervention for Young People With an Autism Spectrum Disorder
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| ClinicalTrials.gov Identifier: NCT01187940 |
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Recruitment Status : Unknown
Verified August 2010 by Institute of Child Health.
Recruitment status was: Not yet recruiting
First Posted : August 24, 2010
Last Update Posted : August 24, 2010
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Efficacy of PEGASUS | Behavioral: PEGASUS | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluating Psychoeducation for People With Autism Spectrum Disorder |
| Study Start Date : | September 2010 |
| Estimated Primary Completion Date : | September 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: PEGASUS
PEGASUS - a psychoeducational group intervention with parallel parent and child sessions.
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Behavioral: PEGASUS
PEGASUS - a psychoeducational group intervention with parallel parent and child sessions. |
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No Intervention: Placebo
Will receive managment as usual from their local educational and NHS services
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- Autism Knowledge Questionnaire [ Time Frame: 30 months ]All measures taken at baseline, termination of treatment and six months follow-up.
- Child Behaviour Checklist [ Time Frame: 30 months ]All measures taken at baseline, termination of treatment and six months follow-up.
- Vineland-II, Rosenburg Self-Esteem Scale [ Time Frame: 30 months ]All measures taken at baseline, termination of treatment and six months follow-up.
- Parenting Stress index [ Time Frame: 30 months ]All measures taken at baseline, termination of treatment and six months follow-up.
- Qualitative interview conducted at baseline and termination. [ Time Frame: 30 months ]
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| Ages Eligible for Study: | 9 Years to 14 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Received an ASD diagnosis from Child and Adolescent Psychiatrist, Clinical Psychologist or Paediatrician.
- Aware of ASD diagnosis.
- Aged between 9 and 14 years.
- Able to function in group setting, as evidenced in educational context.
- Speaks English
Exclusion Criteria:
- No generalised Intellectual Disability as indicated by IQ below 65.
- Not engaged in additional formal psychosocial intervention during study period.
- Not taking psychiatric medication at baseline assessment, or taking a stable dose of psychiatric medication expected to remain constant throughout study participation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187940
| Contact: William Mandy, Dr | w.mandy@ucl.ac.uk |
| United Kingdom | |
| Institute of Child Health | Not yet recruiting |
| London, United Kingdom, WC1N 1EH | |
| Contact: William Mandy, dr w.mandy@ucl.ac.uk | |
| Principal Investigator: David Skuse, Professor | |
| Study Director: | William Mandy, Dr | Institute of Child Health | |
| Principal Investigator: | David Skuse, Professor | Institute of Child Health |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Research Governance Co-ordinator, Institute of Child Health |
| ClinicalTrials.gov Identifier: | NCT01187940 History of Changes |
| Other Study ID Numbers: |
09BS22 |
| First Posted: | August 24, 2010 Key Record Dates |
| Last Update Posted: | August 24, 2010 |
| Last Verified: | August 2010 |
Keywords provided by Institute of Child Health:
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Autism Spectrum Disorder; Psychoeducation |
Additional relevant MeSH terms:
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Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |