Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Initial survey created ad hoc |
Both sociodemographic variables (sex, age, patient's level of studies, parents' level of studies) and clinical variables (current pharmacological treatment - active ingredient and dose) will be collected. |
Baseline |
|
| Primary |
Behavior Rating Inventory of Executive Function - 2 (BRIEF-2) |
A 63-item questionnaire that assesses patient's executive functions (completed by parents). Higher scores in each domain indicate a worse outcome. Spanish norms in T scores (Mean = 50; standard deviation = 10). |
Baseline |
|
| Primary |
Behavior Rating Inventory of Executive Function - 2 (BRIEF-2) |
A 63-item questionnaire that assesses patient's executive functions (completed by parents). Higher scores in each domain indicate a worse outcome. Spanish norms in T scores (Mean = 50; standard deviation = 10). |
6 months |
|
| Primary |
Spanish version of the California Verbal Learning Test for children (TAVECI) |
Assessment of verbal memory in children 3 to 16 years old by the maximum number of remembered elements. |
Baseline |
|
| Primary |
Spanish version of the California Verbal Learning Test (TAVEC) |
Assessment of verbal memory for adolescents 16 to 18 years old by the maximum number of remembered elements. |
Baseline |
|
| Primary |
Spanish version of the California Verbal Learning Test for children (TAVECI) |
Assessment of verbal memory in children 3 to 16 years old by the maximum number of remembered elements. |
6 months |
|
| Primary |
Spanish version of the California Verbal Learning Test (TAVEC) |
Assessment of verbal memory for adolescents 16 to 18 years old by the maximum number of remembered elements. |
6 months |
|
| Primary |
Conners Continuous Auditory Test of Attention (CATA) |
It measures auditory sustained attention. Omissions and commissions are measured for 5 different dimensions: inattentiveness, impulsivity, sustained attention, auditory laterality and auditory mobility. |
Baseline |
|
| Primary |
Conners Continuous Auditory Test of Attention (CATA) |
It measures auditory sustained attention. Omissions and commissions are measured for 5 different dimensions: inattentiveness, impulsivity, sustained attention, auditory laterality and auditory mobility. |
4 weeks |
|
| Primary |
Conners Continuous Auditory Test of Attention (CATA) |
It measures auditory sustained attention. Omissions and commissions are measured for 5 different dimensions: inattentiveness, impulsivity, sustained attention, auditory laterality and auditory mobility. |
6 months |
|
| Primary |
Test of Nonverbal Intelligence, Fourth Edition (TONI-4) form A |
It assesses intellectual functioning free of cultural influences by the total number of items achieved. |
Baseline |
|
| Primary |
Test of Nonverbal Intelligence, Fourth Edition (TONI-4) form B |
It assesses intellectual functioning free of cultural influences by the total number of items achieved. |
6 months |
|
| Primary |
Digit span subtests from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV): Forward, Backward and Sequencing subtests |
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements. |
Baseline |
|
| Primary |
Digit span subtests from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV): Forward, Backward and Sequencing subtests |
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements. |
4 weeks |
|
| Primary |
Digit span subtests from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV): Forward, Backward and Sequencing subtests |
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements. |
6 months |
|
| Primary |
Vocabulary subtest from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) |
It measures semantic memory by the total number of items achieved. |
Baseline |
|
| Primary |
Vocabulary subtest from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) |
It measures semantic memory by the total number of items achieved. |
6 months |
|
| Primary |
Symbol Digit Modalities Test (SDMT) |
It assesses processing speed by the total number of items achieved. |
Baseline |
|
| Primary |
Symbol Digit Modalities Test (SDMT) |
It assesses processing speed by the total number of items achieved. |
4 weeks |
|
| Primary |
Symbol Digit Modalities Test (SDMT) |
It assesses processing speed by the total number of items achieved. |
6 months |
|
| Primary |
The Rey-Osterrieth Complex Figure (ROCF) test |
It measures viso-constructive organisational ability and immediate and delayed visual recall. One point is awarded for each component that is properly reproduced. |
Baseline |
|
| Primary |
The Rey-Osterrieth Complex Figure (ROCF) test |
It measures viso-constructive organisational ability and immediate and delayed visual recall. One point is awarded for each component that is properly reproduced. |
6 months |
|
| Primary |
Fluency Verbal Test (TFV) |
It assesses linguistic-executive functions such as phonological fluency and semantic fluency. One point is awarded for each word that is correctly produced. |
Baseline |
|
| Primary |
Fluency Verbal Test (TFV) |
It assesses linguistic-executive functions such as phonological fluency and semantic fluency. One point is awarded for each word that is correctly produced. |
6 months |
|
| Primary |
Behavioral Assessment System for Children - 3 (BASC-3) |
It measures patients' emotional and behavioural problems, both in its version by the patient's legal guardians and self-reported by the patient. It is an 139-item report, rated on a 4-point frequency Likert scale. High scores indicate problematic levels of functioning. Spanish norms in T scores (Mean = 50; standard deviation = 10). |
Baseline |
|
| Primary |
Behavioral Assessment System for Children - 3 (BASC-3) |
It measures patients' emotional and behavioural problems, both in its version by the patient's legal guardians and self-reported by the patient. It is an 139-item report, rated on a 4-point frequency Likert scale. High scores indicate problematic levels of functioning. Spanish norms in T scores (Mean = 50; standard deviation = 10). |
6 months |
|
| Primary |
Brief Pain Inventory (BPI) |
This 10-item questionnaire includes questions (from 0 to 10 referring to the last 7 days) covering two dimensions: pain intensity (worst and mildest pain in the week, average pain, and current pain), and pain interference (with general activity, mood, walking, school, sleep, as well as enjoyment of life). Higher scores on a Likert scale from 0-10 indicate more pain. |
Baseline |
|
| Primary |
Brief Pain Inventory (BPI) |
This 10-item questionnaire includes questions (from 0 to 10 referring to the last 7 days) covering two dimensions: pain intensity (worst and mildest pain in the week, average pain, and current pain), and pain interference (with general activity, mood, walking, school, sleep, as well as enjoyment of life). Higher scores on a Likert scale from 0-10 indicate more pain. |
2 weeks |
|
| Primary |
Brief Pain Inventory (BPI) |
This 10-item questionnaire includes questions (from 0 to 10 referring to the last 7 days) covering two dimensions: pain intensity (worst and mildest pain in the week, average pain, and current pain), and pain interference (with general activity, mood, walking, school, sleep, as well as enjoyment of life). Higher scores on a Likert scale from 0-10 indicate more pain. |
4 weeks |
|
| Primary |
Brief Pain Inventory (BPI) |
This 10-item questionnaire includes questions (from 0 to 10 referring to the last 7 days) covering two dimensions: pain intensity (worst and mildest pain in the week, average pain, and current pain), and pain interference (with general activity, mood, walking, school, sleep, as well as enjoyment of life). Higher scores on a Likert scale from 0-10 indicate more pain. |
6 months |
|
| Primary |
Adolescent Insomnia Questionnaire (AIQ) |
It is a 13-item questionnaire whose original version is in English. In the present study, this questionnaire will be adapted and validated into Spanish. Higher scores on a Likert scale from 0-4 indicate more insomnia. |
Baseline |
|
| Primary |
Adolescent Insomnia Questionnaire (AIQ) |
It is a 13-item questionnaire whose original version is in English. In the present study, this questionnaire will be adapted and validated into Spanish. Higher scores on a Likert scale from 0-4 indicate more insomnia. |
2 weeks |
|
| Primary |
Adolescent Insomnia Questionnaire (AIQ) |
It is a 13-item questionnaire whose original version is in English. In the present study, this questionnaire will be adapted and validated into Spanish. Higher scores on a Likert scale from 0-4 indicate more insomnia. |
4 weeks |
|
| Primary |
Adolescent Insomnia Questionnaire (AIQ) |
It is a 13-item questionnaire whose original version is in English. In the present study, this questionnaire will be adapted and validated into Spanish. Higher scores on a Likert scale from 0-4 indicate more insomnia. |
6 months |
|
| Primary |
Pediatric Sleep Disturbances Short Form (PROMIS) |
A 4-item questionnaire that assesses problems with sleep reconciliation and sleep maintenance in the last 7 days. Higher scores on a Likert scale from 1-5 indicate worse sleep. |
Baseline |
|
| Primary |
Pediatric Sleep Disturbances Short Form (PROMIS) |
A 4-item questionnaire that assesses problems with sleep reconciliation and sleep maintenance in the last 7 days. Higher scores on a Likert scale from 1-5 indicate worse sleep. |
2 weeks |
|
| Primary |
Pediatric Sleep Disturbances Short Form (PROMIS) |
A 4-item questionnaire that assesses problems with sleep reconciliation and sleep maintenance in the last 7 days. Higher scores on a Likert scale from 1-5 indicate worse sleep. |
4 weeks |
|
| Primary |
Pediatric Sleep Disturbances Short Form (PROMIS) |
A 4-item questionnaire that assesses problems with sleep reconciliation and sleep maintenance in the last 7 days. Higher scores on a Likert scale from 1-5 indicate worse sleep. |
6 months |
|
| Primary |
Simplified Medication Adherence Questionnaire (SMAQ) |
A 6-item self-report that measures adherence to medication. For items 1-4 yes or no answers are required. Item 5 requires a multiple choice answer in terms of frequency (5 different options are provided). Item 6 requires a number input. The final score is a dichotomous variable: non-adherent versus adherent patient. |
Baseline |
|
| Primary |
Simplified Medication Adherence Questionnaire (SMAQ) |
A 6-item self-report that measures adherence to medication. For items 1-4 yes or no answers are required. Item 5 requires a multiple choice answer in terms of frequency (5 different options are provided). Item 6 requires a number input. The final score is a dichotomous variable: non-adherent versus adherent patient. |
2 weeks |
|
| Primary |
Simplified Medication Adherence Questionnaire (SMAQ) |
A 6-item self-report that measures adherence to medication. For items 1-4 yes or no answers are required. Item 5 requires a multiple choice answer in terms of frequency (5 different options are provided). Item 6 requires a number input. The final score is a dichotomous variable: non-adherent versus adherent patient. |
4 weeks |
|
| Primary |
Simplified Medication Adherence Questionnaire (SMAQ) |
A 6-item self-report that measures adherence to medication. For items 1-4 yes or no answers are required. Item 5 requires a multiple choice answer in terms of frequency (5 different options are provided). Item 6 requires a number input. The final score is a dichotomous variable: non-adherent versus adherent patient. |
6 months |
|
