Efficacy of PEGASUSNCT01187940
Evaluating PEGASUS - a Group Intervention for Young People With an Autism Spectrum Disorder
A study testing PEGASUS in people with Efficacy of PEGASUS, run by Institute of Child Health at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Efficacy of PEGASUS
- What is being tested?
- PEGASUS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
William Mandy, Dr contact
United Kingdom1 site
Institute of Child Health
London, WC1N 1EH
William Mandy, dr, w.mandy@ucl.ac.uk
David Skuse, Professor
About this study
Official title: 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.
- Conditions
- Efficacy of PEGASUS
- Being tested
- PEGASUS
- Keywords
- Autism Spectrum Disorder;, Psychoeducation
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEGASUSBehavioural
PEGASUS - a psychoeducational group intervention with parallel parent and child sessions.
| Study group | Role | What they receive |
|---|---|---|
| PEGASUS | Experimental | PEGASUS - a psychoeducational group intervention with parallel parent and child sessions. Receives: Behavioral: PEGASUS |
| Placebo | No intervention | Will receive managment as usual from their local educational and NHS services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Knowledge Questionnaire
All measures taken at baseline, termination of treatment and six months follow-up.
Measured: 30 months
Child Behaviour Checklist
All measures taken at baseline, termination of treatment and six months follow-up.
Measured: 30 months
Vineland-II, Rosenburg Self-Esteem Scale
All measures taken at baseline, termination of treatment and six months follow-up.
Measured: 30 months
Parenting Stress index
All measures taken at baseline, termination of treatment and six months follow-up.
Measured: 30 months
Secondary outcomes (1)
Qualitative interview conducted at baseline and termination.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Efficacy of PEGASUSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Investigators
- William Mandy, Dr, Study director, Institute of Child HealthDavid Skuse, Professor, Principal investigator, Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187940
- Sponsor's protocol ID
- 09BS22
- Status last verified
- Aug 2010
- First submitted
- 23 Aug 2010
- Last updated
- 24 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25132516
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Psychoeducation for People With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT01187940
- Acronym / sponsor ID
- 09BS22
- Conditions
- Efficacy of PEGASUS
- Keywords
- Autism Spectrum Disorder;, Psychoeducation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- First posted
- 24 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEGASUS | Experimental | Behavioral: PEGASUSPEGASUS - a psychoeducational group intervention with parallel parent and child sessions. |
| Placebo | No intervention | –Will receive managment as usual from their local educational and NHS services |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEGASUSPEGASUS - a psychoeducational group intervention with parallel parent and child sessions. | Behavioural | PEGASUS |
Primary outcome
Autism Knowledge Questionnaire
Time frame: 30 months
All measures taken at baseline, termination of treatment and six months follow-up.
Child Behaviour Checklist
Time frame: 30 months
All measures taken at baseline, termination of treatment and six months follow-up.
Vineland-II, Rosenburg Self-Esteem Scale
Time frame: 30 months
All measures taken at baseline, termination of treatment and six months follow-up.
Parenting Stress index
Time frame: 30 months
All measures taken at baseline, termination of treatment and six months follow-up.
1 secondary outcome
Qualitative interview conducted at baseline and termination.
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2010.
- Derived from this study: PubMed 25132516Gordon 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Mandy, Dr contact
William Mandy, Dr study director
Institute of Child Health
David Skuse, Professor principal investigator
Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEGASUS in people with Efficacy of PEGASUS, run by Institute of Child Health at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William Mandy, Dr (w.mandy@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism Knowledge Questionnaire (time frame: 30 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01187940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2010.