AnxietyNCT03028792
Attention Training for Underserved Youth With Anxiety
A study testing Attention Modification Program in people with Anxiety, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study aims to test the efficacy and feasibility of administering a computerized attention training program targeting clinical levels of anxiety in Latino youth between the ages of 8-17. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Attention Modification Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 15 Jun 2020
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Children and parents of children ages 8 through 17 inclusive at the time of initial evaluation 2. Clinically significant levels of anxiety as measured by self-report 3. Unmedicated or on stable medication treatment for at least 6 weeks prior to study entry, with no planned changes for duration of study participation.
- 4. Child is fluent English or Spanish speaker, given that all of our assessments as well as the language-based treatment protocol have thus far only been validated in English and Spanish.
- 5. Parental Informed Consent and Child Informed Assent. Parents must agree to their child's participation in this protocol. Parents will be asked to fill out self-report questionnaires and participate in assessments that will provide us with more information about their child, however parents are not considered "participants" within this protocol, as all treatment is targeted toward their child.
- 6. Child self-identifies as Latino/Hispanic
Who cannot join
- Excessive or Problematic Substance Use as reported per initial telephone screening, or significant disruptive behavior problems within the past 3 months.
- Indication of clinically significant suicidality, mania, or psychotic disorder.
- Any serious psychiatric, psychosocial, or neurological condition (i.e., ADHD, tourettes, anxiety, severe aggression) requiring immediate treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinicas de Salud del Pueblo healthcare system
El Centro, California, 92243
About this study
This study aims to test the efficacy and feasibility of administering a computerized attention training program targeting clinical levels of anxiety in Latino youth between the ages of 8-17. 52 youth from Imperial County, a rural and predominantly Latino region, will be randomized to receive either 1) a 12-session attention modification program (AMP) or 2) an attention condition program (non-active treatment). Clinical assessment of symptom severity will be conducted before, during, and after treatment. We hypothesize that at the end of treatment, children who receive the active intervention (AMP) will show (1) decreased attention bias to anxiety-related triggers using an independent measure of attention bias to assess change and (b) reduced anxiety severity. We also hypothesize that this study will be feasible, tolerable, acceptable, and safe in this underserved sample of Latino youth. This study is an initial step towards demonstrating the feasibility of implementing a novel computerized attention training program in anxiety in underserved community samples.
Read the detailed description
The main aim of this pilot study is to examine the feasibility, tolerability, and acceptability of a computerized attention training program for children who have clinically elevated anxiety. Youth from a rural Latino community, with significant anxiety symptoms (N = 52) will be randomized to an active attention bias modification program (AMP) for four weeks or to an attention control condition (nonactive) for four weeks. Families will be assessed at baseline, mistreatment, post-treatment and 3 month followup. AMP responders will be determined by reduction on a self-report measure of anxiety and a clinician administered assessment. Community health workers (promotoras) will be trained to administer the program to youth. Data will be gathered to examine the feasibility, tolerability, and acceptability of this type of treatment and this mode of service delivery. It is hypothesized that the AMP will be feasible, tolerable, and acceptable to this underserved community sample of ethnic minority youth.
Study Design: Following ascertainment of study eligibility and completion of baseline assessment, youth will be assigned to four weeks of AMP or ACC (attention control condition). All youngsters and their families will undergo a comprehensive baseline assessment and be reassessed at mistreatment, treatment endpoint (week 4) and 3 month followup.
Screening: Youth will be recruited through various mechanisms.
- Flyers will be posted in primary care clinics in Imperial Valley and Los Angeles County. Clinicas de Salud del Pueblo is a private, non-profit corporation providing primary care services throughout Imperial County. Flyers will be posted in the 10 primary care clinics, located in Imperial County.
- The second method for recruiting subjects will be through physician referral from providers within the primary care systems. Prior to the study start, all pediatricians/providers will receive information about the study, symptoms of child anxiety, and the use of a short screening measure to assist in detecting child anxiety. If a provider at one of the clinics identifies a child with anxiety or a parent reports that child has symptoms consistent with anxiety (fears, worries, nervousness, unexplained somatic complaints, etc.), the provider will have the option to explain the study to the parent and give them the study brochures. Alternatively, providers, if able, can also ask parents to sign a consent to contact form, giving the research team permission to contact them directly to discuss the study.
- Providers may also chose to refer the patient to the study promotora who will assist will explaining the study to the participant, screening, and consenting the participants.
- Flyers will also be posted at Sun Valley Behavioral Medical Center, a private medical clinic that serves the medical and mental health needs of children, adolescents and adults in Imperial County. In this case, parents will be expected to call our research team for more information.
- The co-PI on this study, Dr. Denise Chavira has an ongoing school based study being conducted with high school students in Imperial Valley. Given that this study covers a range of ages (8-17), we will also recruit from high schools. As part of the existing consent form (for protocol 14-000663), students are asked to check the box if they are interested in participating in future research studies. We will contact those students who have indicated interest in future studies to discuss the current project.
In all of these methods, the community health worker/promotora/e will contact the parent to conduct an initial screen. Thereafter the promotora and/or research coordinator will arrange an in person meeting with the parent and youth to review the consent with the parent and assent form with the youth and administer the eligibility measures. The initial eligibility assessments will not be conducted until all consent/assent forms have been signed and returned to the research team.
At the end of the eligibility visits, the PIs (Chavira and Chang) will review the questionnaires to determine final eligibility. Those who are eligible will process to the baseline visit where they will receive the AMP or ACC program as well as other measures. We have included a table of these measures as well as the assessment schedule in 10.1 section 1.0.
Attention Modification Program: AMP is a modified version of the dot-probe paradigm similar to the original task used by MacLeod, Mathews, and Tata. Each trial begins with a fixation cross presented in the center of the computer screen for 500 ms. The cross is then replaced by a pair of faces presented in the center of the screen for 500 ms. The face pair disappears and a probe (i.e., the letter "E" or "F") appears immediately in the location of one of the two faces. Participants will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. The letter probe will remain on the screen until the participant responds. Response latencies to identify the probe will be recorded from the onset of the presentation of the letter probe to the button press. A total of 288 training trials will be delivered each session. This paradigm has been modified to facilitate an attention bias away from threatening material. In this case, the probe always replaces the neutral face. Thus, although there will be no specific instruction to direct attention away from the threatening face, on all trials, the position of the neutral face will indicate the position of the probe.
Attention Control Condition: Like AMP, the attention control condition is a dot-probe task that begins with a fixation cross presented in the computer screen for 500ms, is followed by a pair of faces (one neutral, one threatening) for 500ms, and then a trial is completed when the face pair disappears and a probe (letter "E" or "F") appears in the location of one of the two faces. Participants will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. The letter probe will remain on the screen until the participant responds. Response latencies to identify the probe will be recorded from the onset of the presentation of the letter probe to the button press. A total of 288 training trials will be delivered each session. However, in this case, the probe replaces both the neutral and threat face 50% of the time.
Assessment. All parents and children enrolled in the study will complete assessments at baseline, mid-treatment, post-treatment and 3 month followup. Assessments will focus on feasibility outcomes and clinical outcome measures. Further, measures of moderating factors will be included in order to better understand variables (e.g., poverty, attention control, acculturation) that may suggest trends in differential treatment response within the two conditions.
- Conditions
- Anxiety
- Being tested
- Attention Modification Program, Attention Control Condition
- Keywords
- attention training, youth, latino
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Modification ProgramBehavioural
Also called ABM, attention bias modification, attention training
Each trial begins with a fixation cross at the center of the computer screen for 500 ms. The cross is then replaced by a face pair presented in the center of the screen. The face pair disappears and a probe (letter "E" or "F") appears immediately in the location of one of the two previous stimuli. Youth will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. This paradigm has been modified to facilitate an attention bias away from threat material. In this case, the probe always replaces the neutral stimuli. Thus, although there will be no specific instruction to direct attention away from the threat stimuli, on all trials, the position of the neutral stimulus will indicate the position of the probe.
Attention Control ConditionBehavioural
Also called ACC
Each trial begins with a fixation cross presented in the center of the computer screen. The cross is then replaced by a face pair presented in the center of the screen. The face pair disappears and a probe (letter "E" or "F") appears immediately in the location of one of the two previous stimuli. Youth will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. This paradigm is not intended to facilitate an attention bias away from threat material. In this case, the probe randomly replaces the threat or neutral stimulus.
| Study group | Role | What they receive |
|---|---|---|
| Attention Modification Training | Experimental | Attention Modification Program Active computer-based attention training treatment designed to directly but implicitly modify biased attention patterns in anxious patients in service of symptom relief. AMP is a modified version of the dot-probe paradigm similar to the original task used by MacLeod, Mathews, and Tata. This paradigm has been modified to facilitate an attention bias away from threatening material. In this case, the probe always replaces the neutral stimuli. Receives: Behavioral: Attention Modification Program |
| Attention Control Training | Sham comparator | Placebo Comparator: Attention Control Condition Control computer-based attention training task, which is not designed to modify biased attention patterns in anxious patients. ACC is a modified version of the dot-probe paradigm similar to the original task used by MacLeod, Mathews, and Tata. In this case, the probe randomly replaces the neutral stimuli or the threat stimuli. Receives: Behavioral: Attention Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Global Impression-Severity (CGI-S) and Improvement, (CGI-I) Scales, Pre- to Post-Treatment
Participants receiving a post-treatment CGI-I score of 1 (very much improved) or 2 (much improved) on this one-item, 7-point rating will be considered treatment responders.
Measured: through study completion, average of 4 weeks
Secondary outcomes (4)
Change in Attention Network Task Pre- to Post-Treatment
In this version of the cognitive flanker, participants must indicate whether the central target arrow in a set of 5 arrows is pointing to the left or the right. In congruent trials, all 5 arrows point in the same direction (e.g., →→→→→) while in the incongruent trials, the middle arrow points in the opposite direction as the flanking arrows (e.g., →→←→→). Participants are asked to press the left mouse button if the arrow points to the left and right button if it points to the right.
Measured: through study completion, average of 4 weeks
Change in Visual search task Pre to Post-Treatment
we will include a visual search task as an independent task of attention bias designed to measure spatial attention allocation (Rink, Becker, Kellerman \& Roth, 2003). Participants are asked to detect a target stimulus that is embedded in a matrix of distracting stimuli (e.g., a target stimulus, an angry face, might be embedded in a matrix of neutral distractor faces). Attention biases are inferred from faster response times to detect a threatening stimulus in a matrix of neutral stimuli relative to response time to detect neutral stimuli in neutral matrices.
Measured: through study completion, average of 4 weeks
Change in Pediatric Anxiety Rating Scale Pre to Post-treatment
The 50-item PARS is a clinician measure that integrates youth and parent report of the severity of anxiety symptoms, as well as related functional impairment. PARS yields a continuous total score of 0-35.
Measured: through study completion, average of 4 weeks
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Pre- to Post-Treatment
The SCARED is a 41-item measure of anxiety symptoms with youth and parent-reported versions, with scores of > 25 indicating significant anxiety (total range 0-82).
Measured: through study completion, average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start1 Sep 2017
- Primary completion12 Apr 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanna Chang, PhD, University of California, Los Angeles
- Investigators
- Susanna Chang, PhD, Principal investigator, UCLA Department of PsychiatryDenise Chavira, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028792
- Sponsor's protocol ID
- IRB#15-000334
- Status last verified
- Jul 2022
- First submitted
- 13 Jan 2017
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The proposed research will include data from approximately 52 subjects who are participating in a RCT examining the effectiveness of promotora delivered ABM vs. and active control condition for rural Latino youth with anxiety. The final dataset will include self-reported demographic, clinical symptom, functional impairment, and mental health service use data from questionnaires and interviews with the participants. The dataset will be stripped of identifiers prior to release for sharing. We will make the data and available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. This data will be a part of the NIMH data sharing repository - National Database for Clinical Trials Related to Mental Illness, and made available after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Training for Underserved Youth With Anxiety
- ClinicalTrials.gov ID
- NCT03028792
- Acronym / sponsor ID
- IRB#15-000334
- Conditions
- Anxiety
- Keywords
- attention training, youth, latino
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 12 Apr 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 23 Jan 2017 (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 study aims to test the efficacy and feasibility of administering a computerized attention training program targeting clinical levels of anxiety in Latino youth between the ages of 8-17. 52 youth from Imperial County, a rural and predominantly Latino region, will be randomized to receive either 1) a 12-session attention modification program (AMP) or 2) an attention condition program (non-active treatment). Clinical assessment of symptom severity will be conducted before, during, and after treatment. We hypothesize that at the end of treatment, children who receive the active intervention (AMP) will show (1) decreased attention bias to anxiety-related triggers using an independent measure of attention bias to assess change and (b) reduced anxiety severity. We also hypothesize that this study will be feasible, tolerable, acceptable, and safe in this underserved sample of Latino youth. This study is an initial step towards demonstrating the feasibility of implementing a novel computerized attention training program in anxiety in underserved community samples.
Detailed description
The main aim of this pilot study is to examine the feasibility, tolerability, and acceptability of a computerized attention training program for children who have clinically elevated anxiety. Youth from a rural Latino community, with significant anxiety symptoms (N = 52) will be randomized to an active attention bias modification program (AMP) for four weeks or to an attention control condition (nonactive) for four weeks. Families will be assessed at baseline, mistreatment, post-treatment and 3 month followup. AMP responders will be determined by reduction on a self-report measure of anxiety and a clinician administered assessment. Community health workers (promotoras) will be trained to administer the program to youth. Data will be gathered to examine the feasibility, tolerability, and acceptability of this type of treatment and this mode of service delivery. It is hypothesized that the AMP will be feasible, tolerable, and acceptable to this underserved community sample of ethnic minority youth.
Study Design: Following ascertainment of study eligibility and completion of baseline assessment, youth will be assigned to four weeks of AMP or ACC (attention control condition). All youngsters and their families will undergo a comprehensive baseline assessment and be reassessed at mistreatment, treatment endpoint (week 4) and 3 month followup.
Screening: Youth will be recruited through various mechanisms.
- Flyers will be posted in primary care clinics in Imperial Valley and Los Angeles County. Clinicas de Salud del Pueblo is a private, non-profit corporation providing primary care services throughout Imperial County. Flyers will be posted in the 10 primary care clinics, located in Imperial County.
- The second method for recruiting subjects will be through physician referral from providers within the primary care systems. Prior to the study start, all pediatricians/providers will receive information about the study, symptoms of child anxiety, and the use of a short screening measure to assist in detecting child anxiety. If a provider at one of the clinics identifies a child with anxiety or a parent reports that child has symptoms consistent with anxiety (fears, worries, nervousness, unexplained somatic complaints, etc.), the provider will have the option to explain the study to the parent and give them the study brochures. Alternatively, providers, if able, can also ask parents to sign a consent to contact form, giving the research team permission to contact them directly to discuss the study.
- Providers may also chose to refer the patient to the study promotora who will assist will explaining the study to the participant, screening, and consenting the participants.
- Flyers will also be posted at Sun Valley Behavioral Medical Center, a private medical clinic that serves the medical and mental health needs of children, adolescents and adults in Imperial County. In this case, parents will be expected to call our research team for more information.
- The co-PI on this study, Dr. Denise Chavira has an ongoing school based study being conducted with high school students in Imperial Valley. Given that this study covers a range of ages (8-17), we will also recruit from high schools. As part of the existing consent form (for protocol 14-000663), students are asked to check the box if they are interested in participating in future research studies. We will contact those students who have indicated interest in future studies to discuss the current project.
In all of these methods, the community health worker/promotora/e will contact the parent to conduct an initial screen. Thereafter the promotora and/or research coordinator will arrange an in person meeting with the parent and youth to review the consent with the parent and assent form with the youth and administer the eligibility measures. The initial eligibility assessments will not be conducted until all consent/assent forms have been signed and returned to the research team.
At the end of the eligibility visits, the PIs (Chavira and Chang) will review the questionnaires to determine final eligibility. Those who are eligible will process to the baseline visit where they will receive the AMP or ACC program as well as other measures. We have included a table of these measures as well as the assessment schedule in 10.1 section 1.0.
Attention Modification Program: AMP is a modified version of the dot-probe paradigm similar to the original task used by MacLeod, Mathews, and Tata. Each trial begins with a fixation cross presented in the center of the computer screen for 500 ms. The cross is then replaced by a pair of faces presented in the center of the screen for 500 ms. The face pair disappears and a probe (i.e., the letter "E" or "F") appears immediately in the location of one of the two faces. Participants will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. The letter probe will remain on the screen until the participant responds. Response latencies to identify the probe will be recorded from the onset of the presentation of the letter probe to the button press. A total of 288 training trials will be delivered each session. This paradigm has been modified to facilitate an attention bias away from threatening material. In this case, the probe always replaces the neutral face. Thus, although there will be no specific instruction to direct attention away from the threatening face, on all trials, the position of the neutral face will indicate the position of the probe.
Attention Control Condition: Like AMP, the attention control condition is a dot-probe task that begins with a fixation cross presented in the computer screen for 500ms, is followed by a pair of faces (one neutral, one threatening) for 500ms, and then a trial is completed when the face pair disappears and a probe (letter "E" or "F") appears in the location of one of the two faces. Participants will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. The letter probe will remain on the screen until the participant responds. Response latencies to identify the probe will be recorded from the onset of the presentation of the letter probe to the button press. A total of 288 training trials will be delivered each session. However, in this case, the probe replaces both the neutral and threat face 50% of the time.
Assessment. All parents and children enrolled in the study will complete assessments at baseline, mid-treatment, post-treatment and 3 month followup. Assessments will focus on feasibility outcomes and clinical outcome measures. Further, measures of moderating factors will be included in order to better understand variables (e.g., poverty, attention control, acculturation) that may suggest trends in differential treatment response within the two conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Modification Training | Experimental | Behavioral: Attention Modification ProgramAttention Modification Program Active computer-based attention training treatment designed to directly but implicitly modify biased attention patterns in anxious patients in service of symptom relief. AMP is a modified version of the dot-probe paradigm similar to the original task used by MacLeod, Mathews, and Tata. This paradigm has been modified to facilitate an attention bias away from threatening material. In this case, the probe always replaces the neutral stimuli. |
| Attention Control Training | Sham comparator | Behavioral: Attention Control ConditionPlacebo Comparator: Attention Control Condition Control computer-based attention training task, which is not designed to modify biased attention patterns in anxious patients. ACC is a modified version of the dot-probe paradigm similar to the original task used by MacLeod, Mathews, and Tata. In this case, the probe randomly replaces the neutral stimuli or the threat stimuli. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1. Children and parents of children ages 8 through 17 inclusive at the time of initial evaluation 2. Clinically significant levels of anxiety as measured by self-report 3. Unmedicated or on stable medication treatment for at least 6 weeks prior to study entry, with no planned changes for duration of study participation.
- 4. Child is fluent English or Spanish speaker, given that all of our assessments as well as the language-based treatment protocol have thus far only been validated in English and Spanish.
- 5. Parental Informed Consent and Child Informed Assent. Parents must agree to their child's participation in this protocol. Parents will be asked to fill out self-report questionnaires and participate in assessments that will provide us with more information about their child, however parents are not considered "participants" within this protocol, as all treatment is targeted toward their child.
- 6. Child self-identifies as Latino/Hispanic
Key exclusion criteria (3 listed)
- Excessive or Problematic Substance Use as reported per initial telephone screening, or significant disruptive behavior problems within the past 3 months.
- Indication of clinically significant suicidality, mania, or psychotic disorder.
- Any serious psychiatric, psychosocial, or neurological condition (i.e., ADHD, tourettes, anxiety, severe aggression) requiring immediate treatment.
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 |
|---|---|---|
| Attention Modification ProgramAlso: ABM, attention bias modification, attention trainingEach trial begins with a fixation cross at the center of the computer screen for 500 ms. The cross is then replaced by a face pair presented in the center of the screen. The face pair disappears and a probe (letter "E" or "F") appears immediately in the location of one of the two previous stimuli. Youth will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. This paradigm has been modified to facilitate an attention bias away from threat material. In this case, the probe always replaces the neutral stimuli. Thus, although there will be no specific instruction to direct attention away from the threat stimuli, on all trials, the position of the neutral stimulus will indicate the position of the probe. | Behavioural | Attention Modification Training |
| Attention Control ConditionAlso: ACCEach trial begins with a fixation cross presented in the center of the computer screen. The cross is then replaced by a face pair presented in the center of the screen. The face pair disappears and a probe (letter "E" or "F") appears immediately in the location of one of the two previous stimuli. Youth will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. This paradigm is not intended to facilitate an attention bias away from threat material. In this case, the probe randomly replaces the threat or neutral stimulus. | Behavioural | Attention Control Training |
Primary outcome
Change in Clinical Global Impression-Severity (CGI-S) and Improvement, (CGI-I) Scales, Pre- to Post-Treatment
Time frame: through study completion, average of 4 weeks
Participants receiving a post-treatment CGI-I score of 1 (very much improved) or 2 (much improved) on this one-item, 7-point rating will be considered treatment responders.
4 secondary outcomes
Change in Attention Network Task Pre- to Post-Treatment
Time frame: through study completion, average of 4 weeks
Change in Visual search task Pre to Post-Treatment
Time frame: through study completion, average of 4 weeks
Change in Pediatric Anxiety Rating Scale Pre to Post-treatment
Time frame: through study completion, average of 4 weeks
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Pre- to Post-Treatment
Time frame: through study completion, average of 4 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 26 Jul 2022.
- Individual participant dataSharing planned: Yes. The proposed research will include data from approximately 52 subjects who are participating in a RCT examining the effectiveness of promotora delivered ABM vs. and active control condition for rural Latino youth with anxiety. The final dataset will include self-reported demographic, clinical symptom, functional impairment, and mental health service use data from questionnaires and interviews with the participants. The dataset will be stripped of identifiers prior to release for sharing. We will make the data and available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. This data will be a part of the NIMH data sharing repository - National Database for Clinical Trials Related to Mental Illness, and made available after study completion.
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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.
Susanna Chang, PhD principal investigator
UCLA Department of Psychiatry
Denise Chavira, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Modification Program in people with Anxiety, 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 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: finished, as of the sponsor's last update on 26 Jul 2022. 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. Some participants in this study may receive a placebo. 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 Clinical Global Impression-Severity (CGI-S) and Improvement, (CGI-I) Scales, Pre- to Post-Treatment (time frame: through study completion, average of 4 weeks). 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 26 Jul 2022.