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

Sponsor
Institute of Child Health (Other)
Overall Status
Unknown status
CT.gov ID
NCT01187940
Collaborator
(none)
40
1
2

Study Details

Study Description

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
  • Behavioral: PEGASUS
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 1, 2010
Anticipated Primary Completion Date :
Sep 1, 2012

Arms and Interventions

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

Primary Outcome Measures

  1. Autism Knowledge Questionnaire [30 months]

    All measures taken at baseline, termination of treatment and six months follow-up.

  2. Child Behaviour Checklist [30 months]

    All measures taken at baseline, termination of treatment and six months follow-up.

  3. Vineland-II, Rosenburg Self-Esteem Scale [30 months]

    All measures taken at baseline, termination of treatment and six months follow-up.

  4. Parenting Stress index [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. [30 months]

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 Institute of Child Health London United Kingdom WC1N 1EH

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01187940
Other Study ID Numbers:
  • 09BS22
First Posted:
Aug 24, 2010
Last Update Posted:
Aug 24, 2010
Last Verified:
Aug 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2010