Trial Outcomes & Findings for Adapting a Web-Based Professional Development for Mexican School Mental Health Providers Delivering Evidence-Based Intervention for ADHD and ODD (NCT NCT05425966)
NCT ID: NCT05425966
Last Updated: 2024-03-18
Results Overview
Parents will assess ADHD symptoms using the CSI-4. The CSI-4: Parent Checklist contains 18 symptoms for ADHD, Combined type (ADHD:C; 18 items). Each symptom is rated on a 4-point scale (0= never to 3= very often). The average of ADHD:C scores range from zero to four, with higher scores indicating more severe symptoms.
COMPLETED
NA
67 participants
Baseline and post treatment (8 weeks)
2024-03-18
Participant Flow
All participants who enrolled in the study were assigned to the CLS-R-FUERTE active treatment group and were included in the study.
Participant milestones
| Measure |
CLS-R-FUERTE
Active program participation in: a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). via school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
CLS-R-FUERTE: The CLS-R-FUERTE program is a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). It contains the same evidence-based service components to improve youth attention/behavior as the in-person CLS-FUERTE program; specifically, it features school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
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|---|---|
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Overall Study
STARTED
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67
|
|
Overall Study
COMPLETED
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was collected for the youth in the study
Baseline characteristics by cohort
| Measure |
CLS-R-FUERTE
n=67 Participants
Active program participation in: a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). via school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
CLS-R-FUERTE: The CLS-R-FUERTE program is a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). It contains the same evidence-based service components to improve youth attention/behavior as the in-person CLS-FUERTE program; specifically, it features school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
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|---|---|
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Age, Categorical
<=18 years
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23 Participants
n=67 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=67 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=67 Participants
|
|
Age, Continuous
|
8.04 years
n=23 Participants • Age was collected for the youth in the study
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|
Sex: Female, Male
Female
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49 Participants
n=67 Participants
|
|
Sex: Female, Male
Male
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18 Participants
n=67 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
67 Participants
n=67 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=67 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=67 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=67 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=67 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=67 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=67 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=67 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=67 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=67 Participants
|
|
Region of Enrollment
Mexico
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67 participants
n=67 Participants
|
|
ADHD Presentation
Inattentive Profile
|
9 Participants
n=23 Participants • ADHD presentation collected for students in the study
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|
ADHD Presentation
Combined Profile
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14 Participants
n=23 Participants • ADHD presentation collected for students in the study
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ODD Presentation
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10 Participants
n=23 Participants • ODD presentation collected for students in the study
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On medication %
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3 Participants
n=23 Participants • collected for students in the study
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PRIMARY outcome
Timeframe: Baseline and post treatment (8 weeks)Population: The 23 participants who were students were analyzed within this outcome measure
Parents will assess ADHD symptoms using the CSI-4. The CSI-4: Parent Checklist contains 18 symptoms for ADHD, Combined type (ADHD:C; 18 items). Each symptom is rated on a 4-point scale (0= never to 3= very often). The average of ADHD:C scores range from zero to four, with higher scores indicating more severe symptoms.
Outcome measures
| Measure |
CLS-R-FUERTE
n=23 Participants
Active program participation in: a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). via school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
CLS-R-FUERTE: The CLS-R-FUERTE program is a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). It contains the same evidence-based service components to improve youth attention/behavior as the in-person CLS-FUERTE program; specifically, it features school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
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|---|---|
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Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist ADHD Combined Type Symptom Severity Score
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0.82 score on a scale
Standard Deviation 0.52
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PRIMARY outcome
Timeframe: Baseline and post treatment (8 weeks)Population: The 23 participants who were students were the target to be analyzed within this outcome measure data; there was missing teacher-report student outcome for 2 students; thus, the 21 participants who were students and had teacher-report outcome data were analyzed within this outcome measure data
Teachers will assess ADHD symptoms using the CSI-4. The CSI-4: Teacher Checklist contains 18 symptoms for ADHD, Combined type (ADHD:C; 18 items). Each symptom is rated on a 4-point scale (0= never to 3= very often). The average of ADHD:C scores range from zero to four, with higher scores indicating more severe symptoms.
Outcome measures
| Measure |
CLS-R-FUERTE
n=21 Participants
Active program participation in: a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). via school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
CLS-R-FUERTE: The CLS-R-FUERTE program is a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). It contains the same evidence-based service components to improve youth attention/behavior as the in-person CLS-FUERTE program; specifically, it features school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
|
|---|---|
|
Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist ADHD Combined Type Symptom Severity Score
|
0.68 score on a scale
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: Baseline and post treatment (8 weeks)Population: The 23 participants who were students were analyzed within this outcome measure data
Parents will assess ODD symptoms using the CSI-4. The CSI-4: Parent Checklist contains 9 symptoms of ODD. Each symptom is rated on a 4-point scale (0= never to 3= very often). The average ODD scores range from zero to four, with higher scores indicating more severe symptoms.
Outcome measures
| Measure |
CLS-R-FUERTE
n=23 Participants
Active program participation in: a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). via school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
CLS-R-FUERTE: The CLS-R-FUERTE program is a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). It contains the same evidence-based service components to improve youth attention/behavior as the in-person CLS-FUERTE program; specifically, it features school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
|
|---|---|
|
Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score
|
0.54 score on a scale
Standard Deviation 0.62
|
PRIMARY outcome
Timeframe: Baseline and post treatment (8 weeks)Population: The 23 participants who were students were the target to be analyzed within this outcome measure data; there was missing teacher-report student outcome for 4 students; thus, the 19 participants who were students and had teacher-report outcome data were analyzed within this outcome measure data
Teachers will assess ODD symptoms using the CSI-4. The CSI-4: Teacher Checklist contains 9 symptoms of ODD. Each symptom is rated on a 4-point scale (0= never to 3= very often). The average ODD scores range from zero to four, with higher scores indicating more severe symptoms.
Outcome measures
| Measure |
CLS-R-FUERTE
n=19 Participants
Active program participation in: a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). via school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
CLS-R-FUERTE: The CLS-R-FUERTE program is a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). It contains the same evidence-based service components to improve youth attention/behavior as the in-person CLS-FUERTE program; specifically, it features school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
|
|---|---|
|
Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score
|
0.43 score on a scale
Standard Deviation 0.55
|
PRIMARY outcome
Timeframe: Baseline and post treatment (8 weeks)Population: The 23 participants who were students were analyzed within this outcome measure data
Parents will assess impairment using the IRS. The IRS Teacher Questionnaire contains 8 items of functional impairment (i.e., academic and peer relations). Each item is rated on a 7-point scale (1= no problem; does not need treatment/services to 7= extreme impairment; definitely needs treatment/services). The average of all IRS scores range from one to seven, with higher scores indicating more severe impairment.
Outcome measures
| Measure |
CLS-R-FUERTE
n=23 Participants
Active program participation in: a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). via school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
CLS-R-FUERTE: The CLS-R-FUERTE program is a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). It contains the same evidence-based service components to improve youth attention/behavior as the in-person CLS-FUERTE program; specifically, it features school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
|
|---|---|
|
Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score
|
1.82 score on a scale
Standard Deviation 1.15
|
PRIMARY outcome
Timeframe: Baseline and post treatment (8 weeks)Population: The 23 participants who were students were the target to be analyzed within this outcome measure data; there was missing teacher-report student outcome for 2 students; thus, the 21 participants who were students and had teacher-report outcome data were analyzed within this outcome measure data
Teachers will assess impairment using the IRS. The IRS Teacher Questionnaire contains 8 items of functional impairment (i.e., academic and peer relations). Each item is rated on a 7-point scale (1= no problem; does not need treatment/services to 7= extreme impairment; definitely needs treatment/services). The average of all IRS scores range from one to seven, with higher scores indicating more severe impairment.
Outcome measures
| Measure |
CLS-R-FUERTE
n=21 Participants
Active program participation in: a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). via school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
CLS-R-FUERTE: The CLS-R-FUERTE program is a remote school clinician training and comprehensive psychosocial intervention designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). It contains the same evidence-based service components to improve youth attention/behavior as the in-person CLS-FUERTE program; specifically, it features school clinician training by a clinical research team to lead parent skill groups, child skill groups, and teacher consultation in a behavioral classroom management system.
|
|---|---|
|
Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score
|
2.25 score on a scale
Standard Deviation 1.23
|
Adverse Events
CLS-R-FUERTE
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lauren Haack, PhD
University of California San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place