Clinical High RiskNCT02245607
Compensatory Cognitive Training in Clinical High Risk Latino Youth
A study testing Compensatory Cognitive Training and Recreational Therapy in people with Clinical High Risk and Psychosis, run by University of California, San Diego at 2 sites in 2 countries.
Trial summary
This is a randomized study to compare Compensatory Cognitive Training (CCT) versus Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico. Study hypotheses: Compared to those who receive RT, study participants receiving CCT will show significant improvement in neurocognition… Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Clinical High Risk, Psychosis, Prodromal
- What is being tested?
- Compensatory Cognitive Training and Recreational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2014to 1 Feb 2021
- 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 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meet Clinical High Risk criteria
- Be of Latino descent
- Speak Spanish as their preferred language
Who cannot join
- Concomitant medical or neurological illness
- Brain injury with loss of consciousness > 30 minutes
- Current substance abuse (excluding nicotine)
- IQ < 80
- High suicidal risk
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of California San Diego
La Jolla, California, 92093
About this study
This is a randomized study to compare Compensatory Cognitive Training (CCT) versus Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.
Study hypotheses: Compared to those who receive RT, study participants receiving CCT will show significant improvement in neurocognition, functional capacity, self-rated functioning and clinical measures.
Read the detailed description
This is a 12 week randomized study to compare Compensatory Cognitive Training (CCT) versus Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.
Study participants will be measured 3 times, at baseline, 12 and 24 weeks on all outcome measures. Study hypothesis: Study participants receiving CCT will show significant improvement at 12 and 24 weeks compared to baseline in 1) Neurocognition using the Global Cognitive Index z score derived from the MATRICS neurocognitive domain scores, 2) Functional Capacity as assessed by the UCSD Performance-based Skills Assessment (UPSA/UPSA-Adolescent), 3) Self-Rated Functioning as measured by the Specific Level of Functioning Scale (SLoF) and 4) Clinical symptom ratings as measured by the Scale of Prodromal Symptoms (SOPS) total score when compared to subjects receiving RT training across study time.
- Conditions
- Clinical High Risk, Psychosis, Prodromal, Schizophrenia
- Being tested
- Compensatory Cognitive Training, Recreational Therapy
- Keywords
- Psychotic Disorders, Cognitive Training, Mental Disorders, Schizophrenia and Disorders with Psychotic Features
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Mental Disorders, Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compensatory Cognitive TrainingBehavioural
Recreational TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Compensatory Cognitive Training | Experimental | Compensatory Cognitive Training Receives: Behavioral: Compensatory Cognitive Training |
| Recreational Therapy | Active comparator | Recreational Therapy Receives: Behavioral: Recreational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognition (Global Cognitive Index z score)
The CGI is derived based on Z scores across multiple neurocognitive domains and is a representation of global cognition
Measured: 3 and 6 months post-baseline
Secondary outcomes (1)
Functional capacity (UPSA/UPSA-A)
The UPSA total Functional Capacity score is the total of all subscale scores on the UPSA (Finances, Communication, Transportation, Household)
Measured: 3 and 6 month post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startOct 2014
- Primary completion30 Jun 2020
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical High RiskStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kristin Cadenhead, M.D., University of California, San Diego
- Investigators
- Kristin Cadenhead, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245607
- Sponsor's protocol ID
- MH105247
- Other IDs
- 5R34MH105247-03
- Status last verified
- Feb 2021
- First submitted
- 16 Sep 2014
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compensatory Cognitive Training in Clinical High Risk Latino Youth
- ClinicalTrials.gov ID
- NCT02245607
- Acronym / sponsor ID
- MH105247
- Conditions
- Clinical High Risk, Psychosis, Prodromal, Schizophrenia
- Keywords
- Psychotic Disorders, Cognitive Training, Mental Disorders, Schizophrenia and Disorders with Psychotic Features
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2014
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 19 Sep 2014 (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.
This is a randomized study to compare Compensatory Cognitive Training (CCT) versus Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.
Study hypotheses: Compared to those who receive RT, study participants receiving CCT will show significant improvement in neurocognition, functional capacity, self-rated functioning and clinical measures.
Detailed description
This is a 12 week randomized study to compare Compensatory Cognitive Training (CCT) versus Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.
Study participants will be measured 3 times, at baseline, 12 and 24 weeks on all outcome measures. Study hypothesis: Study participants receiving CCT will show significant improvement at 12 and 24 weeks compared to baseline in 1) Neurocognition using the Global Cognitive Index z score derived from the MATRICS neurocognitive domain scores, 2) Functional Capacity as assessed by the UCSD Performance-based Skills Assessment (UPSA/UPSA-Adolescent), 3) Self-Rated Functioning as measured by the Specific Level of Functioning Scale (SLoF) and 4) Clinical symptom ratings as measured by the Scale of Prodromal Symptoms (SOPS) total score when compared to subjects receiving RT training across study time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compensatory Cognitive Training | Experimental | Behavioral: Compensatory Cognitive TrainingCompensatory Cognitive Training |
| Recreational Therapy | Active comparator | Behavioral: Recreational TherapyRecreational Therapy |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Meet Clinical High Risk criteria
- Be of Latino descent
- Speak Spanish as their preferred language
Key exclusion criteria (5 listed)
- Concomitant medical or neurological illness
- Brain injury with loss of consciousness > 30 minutes
- Current substance abuse (excluding nicotine)
- IQ < 80
- High suicidal risk
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 |
|---|---|---|
| Compensatory Cognitive Training | Behavioural | Compensatory Cognitive Training |
| Recreational Therapy | Behavioural | Recreational Therapy |
Primary outcome
Neurocognition (Global Cognitive Index z score)
Time frame: 3 and 6 months post-baseline
The CGI is derived based on Z scores across multiple neurocognitive domains and is a representation of global cognition
1 secondary outcome
Functional capacity (UPSA/UPSA-A)
Time frame: 3 and 6 month post-baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
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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.
Kristin Cadenhead, MD principal investigator
University of California, San Diego
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compensatory Cognitive Training and Recreational Therapy in people with Clinical High Risk and Psychosis, run by University of California, San Diego at 2 sites in 2 countries.
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 3 inclusion and 5 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 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Mexico. 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?
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?
Neurocognition (Global Cognitive Index z score) (time frame: 3 and 6 months post-baseline). 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 8 Feb 2021.