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

Primary Purpose

Efficacy of PEGASUS

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

PEGASUS

About this trial

This is an interventional treatment trial for Efficacy of PEGASUS focused on measuring Autism Spectrum Disorder;, Psychoeducation

Eligibility Criteria

9 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Institute of Child Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PEGASUS

Placebo

Arm Description

PEGASUS - a psychoeducational group intervention with parallel parent and child sessions.

Will receive managment as usual from their local educational and NHS services

Outcomes

Primary Outcome Measures

Autism Knowledge Questionnaire

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

Child Behaviour Checklist

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

Vineland-II, Rosenburg Self-Esteem Scale

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

Parenting Stress index

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

Secondary Outcome Measures

Qualitative interview conducted at baseline and termination.

Full Information

NCT ID

NCT01187940

First Posted

August 23, 2010

Last Updated

August 23, 2010

Sponsor

Institute of Child Health

1. Study Identification

Unique Protocol Identification Number

NCT01187940

Brief Title

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

Official Title

Evaluating Psychoeducation for People With Autism Spectrum Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Unknown status

Study Start Date

September 2010 (undefined)

Primary Completion Date

September 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Institute of Child Health

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Efficacy of PEGASUS

Keywords

Autism Spectrum Disorder;, Psychoeducation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PEGASUS

Arm Type

Experimental

Arm Description

PEGASUS - a psychoeducational group intervention with parallel parent and child sessions.

Arm Title

Placebo

Arm Type

No Intervention

Arm Description

Will receive managment as usual from their local educational and NHS services

Intervention Type

Behavioral

Intervention Name(s)

PEGASUS

Intervention Description

PEGASUS - a psychoeducational group intervention with parallel parent and child sessions.

Primary Outcome Measure Information:

Title

Autism Knowledge Questionnaire

Description

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

Time Frame

30 months

Title

Child Behaviour Checklist

Description

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

Time Frame

30 months

Title

Vineland-II, Rosenburg Self-Esteem Scale

Description

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

Time Frame

30 months

Title

Parenting Stress index

Description

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

Time Frame

30 months

Secondary Outcome Measure Information:

Title

Qualitative interview conducted at baseline and termination.

Time Frame

30 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

William Mandy, Dr

w.mandy@ucl.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Mandy, Dr

Organizational Affiliation

Institute of Child Health

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

David Skuse, Professor

Organizational Affiliation

Institute of Child Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Child Health

City

London

ZIP/Postal Code

WC1N 1EH

Country

United Kingdom

Facility Contact:

First Name & Middle Initial & Last Name & Degree

William Mandy, dr

w.mandy@ucl.ac.uk

First Name & Middle Initial & Last Name & Degree

David Skuse, Professor

12. IPD Sharing Statement

Citations:

PubMed Identifier

25132516

Citation

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.

Results Reference

derived

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

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