22q11.2 Deletion SyndromeNCT01781923
Cognitive Remediation in 22q11DS
A study testing Cognitive remediation program and Small group social skills training in people with 22q11.2 Deletion Syndrome and Velo-Cardio-Facial Syndrome, run by Duke University at 1 site in United States.
Trial summary
The goal of this study is to collect preliminary data on the efficacy of a cognitive remediation program in improving the neurocognitive deficits in children with chromosome 22q11.2 deletion syndrome (22q11DS). Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- 22q11.2 Deletion Syndrome, Velo-Cardio-Facial Syndrome
- What is being tested?
- Cognitive remediation program and Small group social skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2015
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- molecular/cytogenetic confirmation of 22q11DS
Who cannot join
- Intelligence Quotient <60
- diagnosis of psychosis
- pregnancy
- home location does not permit participation in small groups
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health Systems
Durham, North Carolina, 27710
About this study
Official title: A Remediation Program for Children at High-Risk of Schizophrenia: 22q11.2 Deletion Syndrome
The goal of this study is to collect preliminary data on the efficacy of a cognitive remediation program in improving the neurocognitive deficits in children with chromosome 22q11.2 deletion syndrome (22q11DS). This study involves a two part approaching including a computerized cognitive remediation program (CCRP, Posit Science, CA) in combination with a Social Cognitive Training (SCT) program. The computer-based training program has shown encouraging results in improving learning deficits in individuals with schizophrenia and we now seek to adapt them to children with 22q11DS, who have unique needs due to their lower IQ and high risk of psychosis in late adolescence and adulthood. The SCT is a small-group intervention program based on cognitive enhancement therapy, which has been shown to improve social cognition and functionality in adults with schizophrenia. A preliminary study will be performed using this two-pronged approach, to establish the feasibility and gather preliminary data on neurocognition before and after the intervention in these children; these data would enable a larger randomized controlled study to assess the efficacy of this approach.
- Being tested
- Cognitive remediation program, Small group social skills training
- Keywords
- Cognitive remediation, Social Cognition
- Medical subject headings
- DiGeorge Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediation programBehavioural
Also called Posit Science
Subject plays for 30 minutes, 4 times per week, for 12 weeks.
Small group social skills trainingBehavioural
Meet once per week for duration of 40 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Remediation | Experimental | 12 week computer-based cognitive remediation program aimed to improve working memory, processing speed, and verbal learning/memory.
40 week small group social skills training sessions aimed to improve social skills and cognition. Receives: Behavioral: Cognitive remediation program; Behavioral: Small group social skills training |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sustained attention
Sustained attention will be assessed using the Continuous Performance Test.
Measured: Baseline and 12 weeks
Change in executive function.
Measured: Baseline and 12 weeks
Change in verbal memory.
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Social skills
Social skills will be measured using a parental survey called the Social Skills Rating System.
Measured: 40 weeks
Change in brain function and white matter structure.
The study will examine the impact of CCRP upon brain function and white matter structure in children with 22q11DS.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startOct 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 22q11.2 Deletion SyndromeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Harvard University, University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Vandana Shashi, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781923
- Sponsor's protocol ID
- Pro00025985
- Other IDs
- R34MH091314
- Status last verified
- Aug 2015
- First submitted
- 29 Jan 2013
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Remediation Program for Children at High-Risk of Schizophrenia: 22q11.2 Deletion Syndrome
- ClinicalTrials.gov ID
- NCT01781923
- Acronym / sponsor ID
- Pro00025985
- Keywords
- Cognitive remediation, Social Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Harvard University, University of Pittsburgh
- Study start
- Oct 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Feb 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 goal of this study is to collect preliminary data on the efficacy of a cognitive remediation program in improving the neurocognitive deficits in children with chromosome 22q11.2 deletion syndrome (22q11DS). This study involves a two part approaching including a computerized cognitive remediation program (CCRP, Posit Science, CA) in combination with a Social Cognitive Training (SCT) program. The computer-based training program has shown encouraging results in improving learning deficits in individuals with schizophrenia and we now seek to adapt them to children with 22q11DS, who have unique needs due to their lower IQ and high risk of psychosis in late adolescence and adulthood. The SCT is a small-group intervention program based on cognitive enhancement therapy, which has been shown to improve social cognition and functionality in adults with schizophrenia. A preliminary study will be performed using this two-pronged approach, to establish the feasibility and gather preliminary data on neurocognition before and after the intervention in these children; these data would enable a larger randomized controlled study to assess the efficacy of this approach.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation | Experimental | Behavioral: Cognitive remediation program, Behavioral: Small group social skills training12 week computer-based cognitive remediation program aimed to improve working memory, processing speed, and verbal learning/memory. 40 week small group social skills training sessions aimed to improve social skills and cognition. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- molecular/cytogenetic confirmation of 22q11DS
Key exclusion criteria (4 listed)
- Intelligence Quotient <60
- diagnosis of psychosis
- pregnancy
- home location does not permit participation in small groups
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 remediation programAlso: Posit ScienceSubject plays for 30 minutes, 4 times per week, for 12 weeks. | Behavioural | Cognitive Remediation |
| Small group social skills trainingMeet once per week for duration of 40 weeks. | Behavioural | Cognitive Remediation |
Primary outcome
Change in sustained attention
Time frame: Baseline and 12 weeks
Sustained attention will be assessed using the Continuous Performance Test.
Change in executive function.
Time frame: Baseline and 12 weeks
Change in verbal memory.
Time frame: Baseline and 12 weeks
2 secondary outcomes
Social skills
Time frame: 40 weeks
Change in brain function and white matter structure.
Time frame: Baseline and 12 weeks
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 10 Aug 2015.
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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.
Vandana Shashi, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation program and Small group social skills training in people with 22q11.2 Deletion Syndrome and Velo-Cardio-Facial Syndrome, run by Duke University 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 1 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 10 Aug 2015. 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?
Change in sustained attention (time frame: Baseline and 12 weeks). The study lists 3 primary outcomes in all. 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 10 Aug 2015.