Trial Outcomes & Findings for Remote School-Home Program to Improve Youth Attention and Behavior in Mexican Students (NCT NCT05496140)
NCT ID: NCT05496140
Last Updated: 2025-01-15
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
163 participants
Primary outcome timeframe
Baseline and post treatment (8 weeks)
Results posted on
2025-01-15
Participant Flow
Unit of analysis: Schools
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.
|
Care-As-Usual
Continued participation in school care-as-usual
|
|---|---|---|
|
Overall Study
STARTED
|
79 4
|
84 4
|
|
Overall Study
COMPLETED
|
79 4
|
84 4
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Remote School-Home Program to Improve Youth Attention and Behavior in Mexican Students
Baseline characteristics by cohort
| Measure |
CLS-R-FUERTE -Students
n=27 Participants
Students 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.
|
CLS-R-FUERTE -Parents
n=27 Participants
Parents 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.
|
CLS-R-FUERTE -Teachers
n=18 Participants
Teachers 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.
|
CLS-R-FUERTE -School Clinicians
n=7 Participants
School clinicians 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.
|
Care-As-Usual - Students
n=30 Participants
Students continued participation in school care-as-usual
|
Care-As-Usual - Parents
n=30 Participants
Parents continued participation in school care-as-usual
|
Care-As-Usual - Teachers
n=19 Participants
Teachers continued participation in school care-as-usual
|
Care-As-Usual - School Clinicians
n=5 Participants
School clinicians continued participation in school care-as-usual
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
27 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
57 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
106 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
116 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
47 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
163 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
Mexico
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
163 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline and post treatment (8 weeks)Population: The analysis solely focuses on the children cohort of the population, as the intervention is directed at children. Data were not analyzed for the adult population or any other cohort. As such, the Overall Number of Participants Analyzed represents only the children cohort.
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 - Students
n=4 school
Students 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.
|
Care-As-Usual - Students
n=4 school
Students continued participation in school care-as-usual
|
|---|---|---|
|
Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist ADHD Combined Type Symptom Severity Score
Baseline
|
1.73 score on a scale
Standard Deviation 0.63
|
1.90 score on a scale
Standard Deviation 0.60
|
|
Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist ADHD Combined Type Symptom Severity Score
Post treatment
|
0.96 score on a scale
Standard Deviation 0.51
|
1.43 score on a scale
Standard Deviation 0.60
|
PRIMARY outcome
Timeframe: Baseline and post treatment (8 weeks)Population: The analysis solely focuses on the children cohort of the population, as the intervention is directed at children. Data were not analyzed for the adult population or any other cohort. As such, the Overall Number of Participants Analyzed represents only the children cohort.
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 - Students
n=4 school
Students 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.
|
Care-As-Usual - Students
n=4 school
Students continued participation in school care-as-usual
|
|---|---|---|
|
Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist ADHD Combined Type Symptom Severity Score
Baseline
|
1.91 score on a scale
Standard Deviation 0.63
|
1.81 score on a scale
Standard Deviation 0.59
|
|
Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist ADHD Combined Type Symptom Severity Score
Post treatment
|
1.20 score on a scale
Standard Deviation 0.74
|
1.69 score on a scale
Standard Deviation 0.60
|
PRIMARY outcome
Timeframe: Baseline and post treatment (8 weeks)Population: The analysis solely focuses on the children cohort of the population, as the intervention is directed at children. Data were not analyzed for the adult population or any other cohort. As such, the Overall Number of Participants Analyzed represents only the children cohort.
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 - Students
n=4 school
Students 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.
|
Care-As-Usual - Students
n=4 school
Students continued participation in school care-as-usual
|
|---|---|---|
|
Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score
Baseline
|
0.99 score on a scale
Standard Deviation 0.63
|
1.31 score on a scale
Standard Deviation 0.68
|
|
Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score
Post Treatment
|
0.67 score on a scale
Standard Deviation 0.47
|
1.10 score on a scale
Standard Deviation 0.53
|
PRIMARY outcome
Timeframe: Baseline and post treatment (8 weeks)Population: The analysis solely focuses on the children cohort of the population, as the intervention is directed at children. Data were not analyzed for the adult population or any other cohort. As such, the Overall Number of Participants Analyzed represents only the children cohort.
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 - Students
n=4 school
Students 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.
|
Care-As-Usual - Students
n=4 school
Students continued participation in school care-as-usual
|
|---|---|---|
|
Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score
Baseline
|
1.19 score on a scale
Standard Deviation 0.69
|
1.20 score on a scale
Standard Deviation 0.90
|
|
Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score
Post Treatment
|
0.88 score on a scale
Standard Deviation 0.77
|
0.89 score on a scale
Standard Deviation 0.86
|
PRIMARY outcome
Timeframe: Baseline and post treatment (8 weeks)Population: The analysis solely focuses on the children cohort of the population, as the intervention is directed at children. Data were not analyzed for the adult population or any other cohort. As such, the Overall Number of Participants Analyzed represents only the children cohort.
Parents will assess impairment using the IRS. The IRS Parent 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 - Students
n=4 school
Students 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.
|
Care-As-Usual - Students
n=4 school
Students continued participation in school care-as-usual
|
|---|---|---|
|
Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score
Baseline
|
4.03 score on a scale
Standard Deviation 1.59
|
4.03 score on a scale
Standard Deviation 1.33
|
|
Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score
Post treatment
|
1.72 score on a scale
Standard Deviation 0.80
|
2.36 score on a scale
Standard Deviation 0.98
|
PRIMARY outcome
Timeframe: Baseline and post treatment (8 weeks)Population: The analysis solely focuses on the children cohort of the population, as the intervention is directed at children. Data were not analyzed for the adult population or any other cohort. As such, the Overall Number of Participants Analyzed represents only the children cohort.
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 - Students
n=4 school
Students 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.
|
Care-As-Usual - Students
n=4 school
Students continued participation in school care-as-usual
|
|---|---|---|
|
Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score
Baseline
|
5.01 score on a scale
Standard Deviation 1.22
|
5.18 score on a scale
Standard Deviation 1.08
|
|
Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score
Post treatment
|
2.90 score on a scale
Standard Deviation 1.51
|
3.59 score on a scale
Standard Deviation 1.46
|
Adverse Events
CLS-R-FUERTE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Care-As-Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place