ADHD, Oppositional Defiant Disorder
Conditions
Brief summary
Neurodevelopmental disorders of inattention and disruptive behavior, such as Attention-Deficit/ Hyperactivity Disorder (ADHD) and Oppositional Defiant Disorder (ODD), are among the most common youth mental health conditions across cultures. An efficacious and feasible solution to improving affected youth's ADHD/ODD is training existing school clinicians to deliver evidence-based intervention with fidelity. Despite initial promising results of training school clinicians to treat ADHD/ODD in settings suffering from high unmet need, such as Mexico, scalability is limited by a lack of researchers with capacity to train, monitor, and evaluate school clinicians in such efforts on a large scale. Thus, there is a need to develop more feasible interventions and training programs for school clinicians, as well as create a system with capacity for scalable training and evaluation, to combat the widespread impact ofADHD/ODD worldwide. Converting interventions and school clinician professional development programs for fully-remote delivery allows for more flexibility, accessibility, affordability, scalability, and promise for ongoing consultation than in-person options. Supporting scalable training for school clinicians could address a significant public health concern in Mexico, as only 14% of Mexican youth with mental health disorders receive treatment and less than half of those treated receive more than minimally adequate care. The study team is uniquely suited for this effort, given that they developed the only known school-homeADHD/ODD evidence-based intervention in Latin America-and-have developed a web-based training for U.S. school clinicians with promising preliminary results. The study team's prior studies and high levels of unmet need make Mexico an ideal location for this proposal; however, lessons learned could be used to expand scalable school clinician training for evidence-based intervention in other settings and/or for other disorders. Thus, this study focuses on conducting an open-trial of the fully-remote program and make iterative changes. It is predicted that: H1) school clinicians trained remotely will be satisfied and show improved evidence-based practice skills; H2)families and teachers participating remotely will be satisfied and youth will show improved ADHD/ODD; H3) observation/feedback from a 3-school open-trial will guide iterative changes to the remote program.
Interventions
BEHAVIORALCLS-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.
Sponsors
National Institute of Mental Health (NIMH)
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Students meeting the following criteria are eligible: * at least six inattention symptoms and/or six hyperactive/impulsive symptoms endorsed by parent or teacher as occurring often or very often, * at least one area of impairment rated as concerning by both parent and teacher, and * a parent and teacher agreeing to participate. * Students taking medication are eligible as long as regimens were stable. * Parents and teachers and school clinicians of participating are eligible to participate.
Exclusion criteria
All Participants: Anyone who does not speak and read Spanish will be excluded, given that all informed consent, measurement, and activity procedures will be conducted in Spanish. Child Participants * Children taking medication will be eligible for screening after the child has been on a stable medication regimen for at least one month (to minimize chance that treatment effects are due to medication and not the proposed program). * Presence of conditions that are incompatible with this study's treatment. * severe visual or hearing impairment, * severe language delay, * psychosis, * Child does not read or speak Spanish (inability to complete assessment measures or participate in group treatments). * Child is in an all-day special education classroom. Children in these classrooms are frequently receiving intensive behavior modification programs and assistance such that the teacher consultation component would be expected to require modification for use in these settings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist ADHD Combined Type Symptom Severity Score | Baseline and post treatment (8 weeks) | 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. |
| Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist ADHD Combined Type Symptom Severity Score | Baseline and post treatment (8 weeks) | 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. |
| Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score | Baseline and post treatment (8 weeks) | 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. |
| Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score | Baseline and post treatment (8 weeks) | 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. |
| Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score | Baseline and post treatment (8 weeks) | 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. |
| Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score | Baseline and post treatment (8 weeks) | 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. |
Countries
United States
Participant flow
Pre-assignment details
All participants who enrolled in the study were assigned to the CLS-R-FUERTE active treatment group and were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 67 |
| Total | 67 |
Baseline characteristics
| Characteristic | CLS-R-FUERTE |
|---|---|
| ADHD Presentation Combined Profile | 14 Participants |
| ADHD Presentation Inattentive Profile | 9 Participants |
| Age, Categorical <=18 years | 23 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants |
| Age, Continuous | 8.04 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 67 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| ODD Presentation | 10 Participants |
| On medication % | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 67 Participants |
| Region of Enrollment Mexico | 67 participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 67 |
| other Total, other adverse events | 0 / 67 |
| serious Total, serious adverse events | 0 / 67 |
Outcome results
Primary
Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score
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.
Time frame: Baseline and post treatment (8 weeks)
Population: The 23 participants who were students were analyzed within this outcome measure data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLS-R-FUERTE | Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score | 1.82 score on a scale | Standard Deviation 1.15 |
Primary
Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLS-R-FUERTE | Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score | 2.25 score on a scale | Standard Deviation 1.23 |
Primary
Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist ADHD Combined Type Symptom Severity Score
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.
Time frame: Baseline and post treatment (8 weeks)
Population: The 23 participants who were students were analyzed within this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLS-R-FUERTE | Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist ADHD Combined Type Symptom Severity Score | 0.82 score on a scale | Standard Deviation 0.52 |
Primary
Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score
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.
Time frame: Baseline and post treatment (8 weeks)
Population: The 23 participants who were students were analyzed within this outcome measure data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLS-R-FUERTE | 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
Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist ADHD Combined Type Symptom Severity Score
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLS-R-FUERTE | 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
Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLS-R-FUERTE | 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 |