Autism Spectrum DisorderSEBASTIEN JRNCT02010086
Schema, Emotion and Behavior-Based Therapy for School Children
A study testing Individual Cognitive Behavioral Therapy and Standard Community Treatment in people with Autism Spectrum Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The study is a randomized controlled trial to examine the efficacy of individual cognitive behavioral therapy (CBT) relative to a standard community treatment, in youngsters with autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Individual Cognitive Behavioral Therapy and Standard Community Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jun 2016
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets research criteria for a diagnosis of autism, based on child scores on the ADI-R and ADOS tests.
- If taking medication, have maintained a stable dose for 1 month prior to baseline assessment.
- Between the ages of 6-9 years.
- The child's teacher consents to participate in the study to play a modest role in helping implement the intervention and facilitate the school observation assessment.
Who cannot join
- IQ less than 85.
- The child starts taking new medication(s) or current medication dose changes either (a) less than 1 month prior to the diagnostic evaluation, or (b) during the study period.
- The child is participating in an intensive early intervention program for autism such as applied behavior analysis or floortime.
- For any reason the child or parents appear unable to participate in the treatment program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Behavioral Therapy for Core Autism Symptoms in School-Age Children
The study is a randomized controlled trial to examine the efficacy of individual cognitive behavioral therapy (CBT) relative to a standard community treatment, in youngsters with autism spectrum disorder (ASD). The individual CBT program has been tailored over the last five years to the clinical needs of high-functioning youth with ASD.
Read the detailed description
Autism spectrum disorder (ASD) is among the most common childhood developmental disorders. A key goal in the field is the discovery of methods that reduce core autism symptoms. Core autism symptoms include social-cognitive impairments, pragmatic language deficits, and repetitive and rigid behaviors. The core symptoms tend to be stable and resistant to intervention. Most treatments involve group-based social skills training (SST), with limited effects. No treatment for core autism symptoms in school-aged children with ASD meets American Psychological Association guidelines for possible efficacy. Cognitive behavioral therapy (CBT) offers a novel approach for addressing core autism symptoms in higher functioning school-age youngsters. Initial results suggest that individual CBT may also be promising for reducing core autism symptoms (Wood et al., 2009b; Drahota, Wood et al., 2011). The treatment is based on a contemporary model of memory retrieval competition, employing strategies for enhancing the retention of adaptive conceptual and behavioral responses and the suppression of idiosyncratic beliefs and behaviors in daily social contexts, emphasizing the use of deep semantic processing to enhance memory retrieval. We are proposing a randomized controlled trial to examine the efficacy of individual CBT relative to a standard community treatment for youngsters with ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Individual Cognitive Behavioral Therapy, Standard Community Treatment
- Keywords
- Intervention, Autism, Treatment sensitivity, School aged, Cognitive behavioral therapy, Social Skills Intervention
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Cognitive Behavioral TherapyBehavioural
Therapists will work with families for 32 weekly sessions, each lasting 90 minutes, implementing the CBT manual for children with ASD (Wood et al., 2007).
Standard Community TreatmentBehavioural
In this condition, the child meets with a therapist for 32 weekly sessions, each 90 minutes. Therapists use an established manual to provide a standard community therapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Individual Cognitive Behavioral Therapy | Experimental | Not described Receives: Behavioral: Individual Cognitive Behavioral Therapy |
| Standard Community Treatment | Active comparator | Not described Receives: Behavioral: Standard Community Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Playground Observation of Peer Engagement scale
An independent evaluator-rated school playground observational measure of joint engagement, which is a valid measure of core autism symptoms with established treatment sensitivity
Measured: Post-Treatment (week 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startDec 2011
- Primary completionNov 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey J. Wood, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010086
- Sponsor's protocol ID
- 12000556
- Other IDs
- Autism Speaks 7552
- Acronym
- SEBASTIEN JR
- Status last verified
- Sep 2018
- First submitted
- 9 Dec 2013
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Wood JJ, Kuhfeld M, Sturm A, Cai L, Wood KS, Cornejo Guevara MV, Galan CA, Johnson AR, Cho AC, Weisz JR. Personalized autism symptom assessment with the Youth Top Problems Scale: Observational and parent-report formats for clinical trials applications. Psychol Assess. 2022 Jan;34(1):43-57. doi: 10.1037/pas0001065. Epub 2021 Aug 30.
PubMed 34460285Wood JJ, Sze Wood K, Chuen Cho A, Rosenau KA, Cornejo Guevara M, Galan C, Bazzano A, Zeldin AS, Hellemann G. Modular cognitive behavioral therapy for autism-related symptoms in children: A randomized controlled trial. J Consult Clin Psychol. 2021 Feb;89(2):110-125. doi: 10.1037/ccp0000621.
PubMed 33705167
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Core Autism Symptoms in School-Age Children
- ClinicalTrials.gov ID
- NCT02010086
- Acronym / sponsor ID
- SEBASTIEN JR / 12000556
- Conditions
- Autism Spectrum Disorder
- Keywords
- Intervention, Autism, Treatment sensitivity, School aged, Cognitive behavioral therapy, Social Skills Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Dec 2013 (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.
The study is a randomized controlled trial to examine the efficacy of individual cognitive behavioral therapy (CBT) relative to a standard community treatment, in youngsters with autism spectrum disorder (ASD). The individual CBT program has been tailored over the last five years to the clinical needs of high-functioning youth with ASD.
Detailed description
Autism spectrum disorder (ASD) is among the most common childhood developmental disorders. A key goal in the field is the discovery of methods that reduce core autism symptoms. Core autism symptoms include social-cognitive impairments, pragmatic language deficits, and repetitive and rigid behaviors. The core symptoms tend to be stable and resistant to intervention. Most treatments involve group-based social skills training (SST), with limited effects. No treatment for core autism symptoms in school-aged children with ASD meets American Psychological Association guidelines for possible efficacy. Cognitive behavioral therapy (CBT) offers a novel approach for addressing core autism symptoms in higher functioning school-age youngsters. Initial results suggest that individual CBT may also be promising for reducing core autism symptoms (Wood et al., 2009b; Drahota, Wood et al., 2011). The treatment is based on a contemporary model of memory retrieval competition, employing strategies for enhancing the retention of adaptive conceptual and behavioral responses and the suppression of idiosyncratic beliefs and behaviors in daily social contexts, emphasizing the use of deep semantic processing to enhance memory retrieval. We are proposing a randomized controlled trial to examine the efficacy of individual CBT relative to a standard community treatment for youngsters with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Cognitive Behavioral Therapy | Experimental | Behavioral: Individual Cognitive Behavioral Therapy |
| Standard Community Treatment | Active comparator | Behavioral: Standard Community Treatment |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Meets research criteria for a diagnosis of autism, based on child scores on the ADI-R and ADOS tests.
- If taking medication, have maintained a stable dose for 1 month prior to baseline assessment.
- Between the ages of 6-9 years.
- The child's teacher consents to participate in the study to play a modest role in helping implement the intervention and facilitate the school observation assessment.
Key exclusion criteria (4 listed)
- IQ less than 85.
- The child starts taking new medication(s) or current medication dose changes either (a) less than 1 month prior to the diagnostic evaluation, or (b) during the study period.
- The child is participating in an intensive early intervention program for autism such as applied behavior analysis or floortime.
- For any reason the child or parents appear unable to participate in the treatment program.
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 |
|---|---|---|
| Individual Cognitive Behavioral TherapyTherapists will work with families for 32 weekly sessions, each lasting 90 minutes, implementing the CBT manual for children with ASD (Wood et al., 2007). | Behavioural | Individual Cognitive Behavioral Therapy |
| Standard Community TreatmentIn this condition, the child meets with a therapist for 32 weekly sessions, each 90 minutes. Therapists use an established manual to provide a standard community therapy treatment. | Behavioural | Standard Community Treatment |
Primary outcome
Playground Observation of Peer Engagement scale
Time frame: Post-Treatment (week 32)
An independent evaluator-rated school playground observational measure of joint engagement, which is a valid measure of core autism symptoms with established treatment sensitivity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Derived from this study: PubMed 34460285Wood JJ, Kuhfeld M, Sturm A, Cai L, Wood KS, Cornejo Guevara MV, Galan CA, Johnson AR, Cho AC, Weisz JR. Personalized autism symptom assessment with the Youth Top Problems Scale: Observational and parent-report formats for clinical trials applications. Psychol Assess. 2022 Jan;34(1):43-57. doi: 10.1037/pas0001065. Epub 2021 Aug 30.
- Derived from this study: PubMed 33705167Wood JJ, Sze Wood K, Chuen Cho A, Rosenau KA, Cornejo Guevara M, Galan C, Bazzano A, Zeldin AS, Hellemann G. Modular cognitive behavioral therapy for autism-related symptoms in children: A randomized controlled trial. J Consult Clin Psychol. 2021 Feb;89(2):110-125. doi: 10.1037/ccp0000621.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Cognitive Behavioral Therapy and Standard Community Treatment in people with Autism Spectrum Disorder, run by University of California, Los Angeles at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 7 Sep 2018. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Playground Observation of Peer Engagement scale (time frame: Post-Treatment (week 32)). 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 NCT02010086, which also lists 2 linked publications.
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 7 Sep 2018.