Evaluating PEGASUS - a Group Intervention for Young People With an Autism Spectrum Disorder

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: PEGASUS; PEGASUS - a psychoeducational group intervention with parallel parent and child sessions.	Behavioral: PEGASUS; PEGASUS - a psychoeducational group intervention with parallel parent and child sessions.
No Intervention: Placebo; Will receive managment as usual from their local educational and NHS services

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Autism Knowledge Questionnaire [ Time Frame: 30 months ]
   All measures taken at baseline, termination of treatment and six months follow-up.
2. Child Behaviour Checklist [ Time Frame: 30 months ]
   All measures taken at baseline, termination of treatment and six months follow-up.
3. Vineland-II, Rosenburg Self-Esteem Scale [ Time Frame: 30 months ]
   All measures taken at baseline, termination of treatment and six months follow-up.
4. Parenting Stress index [ Time Frame: 30 months ]
   All measures taken at baseline, termination of treatment and six months follow-up.

Secondary Outcome Measures :

1. Qualitative interview conducted at baseline and termination. [ Time Frame: 30 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	9 Years to 14 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: William Mandy, Dr		w.mandy@ucl.ac.uk

Locations

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

Sponsors and Collaborators

Institute of Child Health

Investigators

Study Director:	William Mandy, Dr	Institute of Child Health
Principal Investigator:	David Skuse, Professor	Institute of Child Health

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gordon K, Murin M, Baykaner O, Roughan L, Livermore-Hardy V, Skuse D, Mandy W. A randomised controlled trial of PEGASUS, a psychoeducational programme for young people with high-functioning autism spectrum disorder. J Child Psychol Psychiatry. 2015 Apr;56(4):468-76. doi: 10.1111/jcpp.12304. Epub 2014 Aug 1.

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
Last Update Posted:	August 24, 2010
Last Verified:	August 2010

Keywords provided by Institute of Child Health:

Autism Spectrum Disorder; Psychoeducation

Additional relevant MeSH terms:

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders