Autism Spectrum DisorderEarly Phase 1NCT01031511
Effect of Cognitive Behavioural Therapy (CBT) for Children With Autistic Spectrum Disorders
A Early Phase 1 study testing Cognitive Behavioural Therapy and Social Recreational in people with Autism Spectrum Disorder and Anxiety, run by National Healthcare Group, Singapore at 1 site in Singapore.
Trial summary
Cognitive Behavioural Therapy is an effective intervention program for children with High-Functioning Autistic Spectrum Disorder to remediate anxiety issues. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Autism Spectrum Disorder, Anxiety
- What is being tested?
- Cognitive Behavioural Therapy and Social Recreational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2005to Feb 2011
- Phase
- Early Phase 1
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Assessed to have Autistic Spectrum Disorder, Asperger Syndrome, Pervasive Developmental Disorder, Not Otherwise Specified by the DSM-IV criteria, based on clinical interview, Asperger Syndrome Diagnostic Scale (ASDS) or Autism Diagnostic Observation Schedule (ADOS)
- Child have a Verbal Comprehension Index of 80 and Perceptual Reasoning Index of 90 and above
- No change of medication dosage 1 month prior to the commencement of program for the child and through out the duration of the study
- Written parental consent and assent from children above 12 years old
Who cannot join
- Children with Verbal Comprehension Index of 80 and Perceptual Reasoning Index of 90 and below.
- Children who are undergoing other Cognitive Behavioural treatment program concurrently
- Those without parental consent will not be able to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial on the Effect of Cognitive-behavioural Therapy for High-functioning Children With Autistic Spectrum Disorder
Cognitive Behavioural Therapy is an effective intervention program for children with High-Functioning Autistic Spectrum Disorder to remediate anxiety issues.
- Conditions
- Autism Spectrum Disorder, Anxiety
- Being tested
- Cognitive Behavioural Therapy, Social Recreational
- Keywords
- High-Functioning Autistic Spectrum Disorder, Anxiety, Cognitive Behavioural Therapy, Social Recreational, Parent Stress
- Medical subject headings
- Autism Spectrum Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
16 weekly sessions of 1.5 hrs in small groups of 3-4 children conducted by 2 therapists
Social RecreationalOther
16 weekly sessions of 1.5 hrs in small groups of 3-4 children, conducted by 2 therapists
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group - CBT | Experimental | Not described Receives: Behavioral: Cognitive Behavioural Therapy |
| Control Group | No intervention | Not described Receives: Other: Social Recreational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level of child
Measured: Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up
Secondary outcomes (1)
Parent Stress Level
Measured: Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startJun 2005
- Primary completionJan 2010 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Healthcare Group, Singapore
- Sponsor type
- Other government
- Collaborators
- Nanyang Technological University, Autism Resource Centre, Singapore
- Investigators
- Min Sung, Principal investigator, Institute of Mental Health, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031511
- Sponsor's protocol ID
- DSRB Ref Code: A/05/091
- Other IDs
- NMRC/1002/2005, 130/2005
- Status last verified
- Feb 2009
- First submitted
- 11 Dec 2009
- Last updated
- 14 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial on the Effect of Cognitive-behavioural Therapy for High-functioning Children With Autistic Spectrum Disorder
- ClinicalTrials.gov ID
- NCT01031511
- Acronym / sponsor ID
- DSRB Ref Code: A/05/091
- Conditions
- Autism Spectrum Disorder, Anxiety
- Keywords
- High-Functioning Autistic Spectrum Disorder, Anxiety, Cognitive Behavioural Therapy, Social Recreational, Parent Stress
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (actual)
- Lead sponsor
- National Healthcare Group, SingaporeOther government
- Collaborators
- Nanyang Technological University, Autism Resource Centre, Singapore
- Study start
- Jun 2005
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 14 Dec 2009 (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.
Cognitive Behavioural Therapy is an effective intervention program for children with High-Functioning Autistic Spectrum Disorder to remediate anxiety issues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group - CBT | Experimental | Behavioral: Cognitive Behavioural Therapy |
| Control Group | No intervention | Other: Social Recreational |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Assessed to have Autistic Spectrum Disorder, Asperger Syndrome, Pervasive Developmental Disorder, Not Otherwise Specified by the DSM-IV criteria, based on clinical interview, Asperger Syndrome Diagnostic Scale (ASDS) or Autism Diagnostic Observation Schedule (ADOS)
- Child have a Verbal Comprehension Index of 80 and Perceptual Reasoning Index of 90 and above
- No change of medication dosage 1 month prior to the commencement of program for the child and through out the duration of the study
- Written parental consent and assent from children above 12 years old
Key exclusion criteria (3 listed)
- Children with Verbal Comprehension Index of 80 and Perceptual Reasoning Index of 90 and below.
- Children who are undergoing other Cognitive Behavioural treatment program concurrently
- Those without parental consent will not be able to participate
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 |
|---|---|---|
| Cognitive Behavioural Therapy16 weekly sessions of 1.5 hrs in small groups of 3-4 children conducted by 2 therapists | Behavioural | Treatment Group - CBT |
| Social Recreational16 weekly sessions of 1.5 hrs in small groups of 3-4 children, conducted by 2 therapists | Other | Control Group |
Primary outcome
Anxiety level of child
Time frame: Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up
1 secondary outcome
Parent Stress Level
Time frame: Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2009.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
Min Sung principal investigator
Institute of Mental Health, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cognitive Behavioural Therapy and Social Recreational in people with Autism Spectrum Disorder and Anxiety, run by National Healthcare Group, Singapore at 1 site in Singapore.
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 4 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 14 Dec 2009. 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 Singapore. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level of child (time frame: Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2009.