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

August 23, 2010 updated by: Institute of Child Health

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 1EH
        • Institute of Child Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 14 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autism Knowledge Questionnaire
Time Frame: 30 months
All measures taken at baseline, termination of treatment and six months follow-up.
30 months
Child Behaviour Checklist
Time Frame: 30 months
All measures taken at baseline, termination of treatment and six months follow-up.
30 months
Vineland-II, Rosenburg Self-Esteem Scale
Time Frame: 30 months
All measures taken at baseline, termination of treatment and six months follow-up.
30 months
Parenting Stress index
Time Frame: 30 months
All measures taken at baseline, termination of treatment and six months follow-up.
30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Qualitative interview conducted at baseline and termination.
Time Frame: 30 months
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Child Health

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ANTICIPATED)

September 1, 2012

Study Registration Dates

First Submitted

August 23, 2010

First Submitted That Met QC Criteria

August 23, 2010

First Posted (ESTIMATE)

August 24, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 24, 2010

Last Update Submitted That Met QC Criteria

August 23, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09BS22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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