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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Institute of Child Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT01187940
First received: August 23, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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 Intervention
Efficacy of PEGASUS
 Behavioral: PEGASUS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating Psychoeducation for People With Autism Spectrum Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute of Child Health:

Primary Outcome Measures:
  • Autism Knowledge Questionnaire [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    All measures taken at baseline, termination of treatment and six months follow-up.

  • Child Behaviour Checklist [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    All measures taken at baseline, termination of treatment and six months follow-up.

  • Vineland-II, Rosenburg Self-Esteem Scale [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    All measures taken at baseline, termination of treatment and six months follow-up.

  • Parenting Stress index [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    All measures taken at baseline, termination of treatment and six months follow-up.


Secondary Outcome Measures:
  • Qualitative interview conducted at baseline and termination. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   9 Years to 14 Years   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187940

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

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 
Study First Received: August 23, 2010
Last Updated: August 23, 2010
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on September 23, 2016