Adolescent - Emotional ProblemNCT03545685
Intervention of Attenuated Psychosis Syndrome With M-Health Technology
A study testing specific memory and attention realtime training in people with Adolescent - Emotional Problem, run by Florida A&M University at 1 site in China.
Trial summary
The investigators will develop a culturally sensitive smart phone application to enhance neurocognitive function (memory and attention in particular) of participants with attenuated psychosis syndrome (APS). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Adolescent - Emotional Problem
- What is being tested?
- specific memory and attention realtime training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 Jul 2019
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female between 18 and 45 years old.
- Understand and sign an informed consent (or assent for minors) document.
- Must meet the substance use criteria: No DSM IV Alcohol or Drug Dependence in the past 3 months; No use on the day of assessment, clearly not high or hung-over.
- Meet diagnostic criteria for a prodromal syndrome. If under the age of 19 and meets diagnostic criteria for Schizotypal Personality Disorder or meets the diagnostic criteria called the Criteria for Prodromal Syndromes (COPS) which are operationalized as follows:
- Genetic Risk and Deterioration Syndrome (GRDS): First degree relative with psychosis or subject with Schizotypal Personality Disorder and a 30% drop in GAF score compared to one year ago, sustained over the past month, or
- Attenuated Positive Symptoms Syndrome (APSS): Severity rating of moderate (rating of 3), moderately severe (4) or severe but not psychotic (5) on any one of the five SOPS positive symptoms; symptom occurs at above severity level at an average frequency of at least once per week in the past month; symptom must have begun in the past year or currently rates at least one scale point higher than rated 12 months previously, or
- Brief Intermittent Psychotic Syndrome (BIPS): Severity rating of psychotic intensity (6) on any of the 5 SOPS positive symptoms 94; symptom is present at least several minutes per day at a frequency of at least once per month; symptom(s) must have reached a psychotic intensity in the past 3 months; symptom is not seriously disorganizing or dangerous; symptom(s) do not last for more than 1 hour/day at an average frequency of 4 days/week over 1 month.
Who cannot join
- Meet criteria for current or lifetime Axis I psychotic disorder, including affective psychoses and psychosis NOS.
- Impaired intellectual functioning (i.e. IQ<70).
- Past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.
- Traumatic Brain Injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument (signifying a significant brain injury with persistent sequelae).
- The diagnostic prodromal symptoms are clearly caused by an Axis 1 disorder, including substance use disorders, in the judgment of the evaluating clinician. Other non-psychotic disorders will not be exclusionary (e.g. substance abuse disorder, major depression, anxiety disorders, Axis II Disorders), as long as the disorder does not account for the diagnosis of prodromal symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Intervention of Attenuated Psychosis Syndrome With M-Health Technology
The investigators will develop a culturally sensitive smart phone application to enhance neurocognitive function (memory and attention in particular) of participants with attenuated psychosis syndrome (APS).
Read the detailed description
The investigator will conduct a pilot study of 80 APS subjects (age 18-45). Forty subjects will be randomly put in the SMART plus routine care (RC) group and 40 to RC group only. At baseline and 3-month follow-ups, all subjects will complete questionnaires including Mobile App Rating Scale SMART feasibility and engagement. 1:1 in-depth interviews will be conducted at the two time points to cross-validate the findings obtained from the questionnaires. The questionnaires and in-depth interviews for APS subjects for the RC group seek to explore their preference and likelihood to use SMART given the opportunity. Examine Cognitive Function Change. In order to prepare for future large scale randomized clinical trials, the investigator will examine the effectiveness of SMART in improving working memory and attention of APS subjects. At baseline and 3-month follow-ups, all subjects will complete MATRICS Consensus Cognitive Battery (MCCB) subtests measuring working memory (Spatial Span) and attention (Continuous Performance Test-Identical Pairs). A between and within group design allows examining change of outcome variables over time and group differences. Enhance mHealth research capacity of SMHC at individual and organization levels.
- Conditions
- Adolescent - Emotional Problem
- Being tested
- specific memory and attention realtime training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific memory and attention realtime trainingOther
The investigator will conduct a pilot study of 80 APS subjects (age 18-45). The investigator will examine SMART feasibility and user engagement using a randomized control trial research design. Using a simple random method, 40 APS subjects will be randomly assigned to the experimental group to receive add-on SMART intervention for 3 months and 40 APS subjects will just get naturalistic treatment with no SMART intervention. At baseline and 3-month follow-up, subjects will complete questionnaires on app use habits and attitudes towards SMART feasibility and engagement. In-depth interviews will be conducted at both time points to cross-validate the findings obtained from the questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| SMART | Experimental | The subjects in SMART training group will receive add-on SMART intervention for 3 months. Subjects will play cognitive games for 1 hour per day, five days per week. SMART will track game time, resource use, and text messaging information on a daily basis, which allows researchers/clinicians to monitor subjects' daily SMART activities. Daily end-of-day RedPocket incentives will be delivered to subjects' designated account based on their resource use and game time. Top 5 APS subjects who play the game for the most time in a week will be rewarded Receives: Other: specific memory and attention realtime training |
| Control group | Other | Participants in this group will serve as control group Receives: Other: specific memory and attention realtime training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory and attention scores
Memory and attention score will be assessed at 3 month followup
Measured: 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Aug 2017
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent - Emotional ProblemStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545685
- Sponsor's protocol ID
- 005680
- Status last verified
- Jul 2019
- First submitted
- 4 May 2018
- Last updated
- 2 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Intervention of Attenuated Psychosis Syndrome With M-Health Technology
- ClinicalTrials.gov ID
- NCT03545685
- Acronym / sponsor ID
- 005680
- Conditions
- Adolescent - Emotional Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Florida A&M UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 4 Jun 2018 (actual)
- 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 investigators will develop a culturally sensitive smart phone application to enhance neurocognitive function (memory and attention in particular) of participants with attenuated psychosis syndrome (APS).
Detailed description
The investigator will conduct a pilot study of 80 APS subjects (age 18-45). Forty subjects will be randomly put in the SMART plus routine care (RC) group and 40 to RC group only. At baseline and 3-month follow-ups, all subjects will complete questionnaires including Mobile App Rating Scale SMART feasibility and engagement. 1:1 in-depth interviews will be conducted at the two time points to cross-validate the findings obtained from the questionnaires. The questionnaires and in-depth interviews for APS subjects for the RC group seek to explore their preference and likelihood to use SMART given the opportunity. Examine Cognitive Function Change. In order to prepare for future large scale randomized clinical trials, the investigator will examine the effectiveness of SMART in improving working memory and attention of APS subjects. At baseline and 3-month follow-ups, all subjects will complete MATRICS Consensus Cognitive Battery (MCCB) subtests measuring working memory (Spatial Span) and attention (Continuous Performance Test-Identical Pairs). A between and within group design allows examining change of outcome variables over time and group differences. Enhance mHealth research capacity of SMHC at individual and organization levels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART | Experimental | Other: specific memory and attention realtime trainingThe subjects in SMART training group will receive add-on SMART intervention for 3 months. Subjects will play cognitive games for 1 hour per day, five days per week. SMART will track game time, resource use, and text messaging information on a daily basis, which allows researchers/clinicians to monitor subjects' daily SMART activities. Daily end-of-day RedPocket incentives will be delivered to subjects' designated account based on their resource use and game time. Top 5 APS subjects who play the game for the most time in a week will be rewarded |
| Control group | Other | Other: specific memory and attention realtime trainingParticipants in this group will serve as control group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female between 18 and 45 years old.
- Understand and sign an informed consent (or assent for minors) document.
- Must meet the substance use criteria: No DSM IV Alcohol or Drug Dependence in the past 3 months; No use on the day of assessment, clearly not high or hung-over.
- Meet diagnostic criteria for a prodromal syndrome. If under the age of 19 and meets diagnostic criteria for Schizotypal Personality Disorder or meets the diagnostic criteria called the Criteria for Prodromal Syndromes (COPS) which are operationalized as follows:
Key exclusion criteria (5 listed)
- Meet criteria for current or lifetime Axis I psychotic disorder, including affective psychoses and psychosis NOS.
- Impaired intellectual functioning (i.e. IQ<70).
- Past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.
- Traumatic Brain Injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument (signifying a significant brain injury with persistent sequelae).
- The diagnostic prodromal symptoms are clearly caused by an Axis 1 disorder, including substance use disorders, in the judgment of the evaluating clinician. Other non-psychotic disorders will not be exclusionary (e.g. substance abuse disorder, major depression, anxiety disorders, Axis II Disorders), as long as the disorder does not account for the diagnosis of prodromal symptoms.
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 |
|---|---|---|
| specific memory and attention realtime trainingThe investigator will conduct a pilot study of 80 APS subjects (age 18-45). The investigator will examine SMART feasibility and user engagement using a randomized control trial research design. Using a simple random method, 40 APS subjects will be randomly assigned to the experimental group to receive add-on SMART intervention for 3 months and 40 APS subjects will just get naturalistic treatment with no SMART intervention. At baseline and 3-month follow-up, subjects will complete questionnaires on app use habits and attitudes towards SMART feasibility and engagement. In-depth interviews will be conducted at both time points to cross-validate the findings obtained from the questionnaires. | Other | Control group, SMART |
Primary outcome
Memory and attention scores
Time frame: 3rd month
Memory and attention score will be assessed at 3 month followup
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 2 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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 specific memory and attention realtime training in people with Adolescent - Emotional Problem, run by Florida A&M University at 1 site in China.
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 7 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: finished, as of the sponsor's last update on 2 Aug 2019. 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 China. 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?
Memory and attention scores (time frame: 3rd month). 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 2 Aug 2019.