1. Centro de Investigación Biomédica En Red
Development and Initial Validation of a Medication Side-Effect Suicidality Scale for Children and Adolescents
P. Santosh1, I. Flamarique2, D. Purper-Ouakil3, A. Zuddas4, C. Arango5, A. Sutcliffe6, H. Hanna6, U. Schulze7, J. Castro-Fornieles2 and the STOP consortium. 1King’s College London & Centre for Interventional Paediatric Psychopharmacology, South London & Maudsley Hospital, London, United Kingdom; 2Hospital Clinic of Barcelona. CIBERSAM., Department of Child and Adolescent Psychiatry and Psychology, Barcelona, Spain. 3Hôpital Saint Eloi Médecine Psychologique de l’Enfant et de l’Adolescent Montpellier, CHRU Montpellier, Montpellier, France. 4University of Cagliari, Department of Biomedical Sciences, Cagliari, Italy. 5Hospital General Universitario Gregorio Marañón. CIBERSAM, Child and Adolescent Psychiatry Department, Madrid, Spain. 6University College London, Institute of Child Health, London, United Kingdom. 7University of Ulm, Department of Child and Adolescent Psychiatry/Psychotherapy, Ulm, Germany.
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Centro de Investigación Biomédica En Red
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Background: The emergence of suicidality in patients receiving drug treatment is of concern because of the overall burden and the possible link with completed suicide. The lack of uniform requirements for defining, detecting and recording suicidality and the presence of disease related confounders create major problems. It is possible that Medication-Related Suicidality is different from Psychopathology-Related Suicidality and may vary between children and adults.
Development of the STOP suicidality scale
PHASE I
Based on:
Items covered by UKU and other scales that were relevant to suicidality
Expert’s opinion
STOP scales
Item generation
Experts review
PHASE II
Focus groups
Parents, children
and adolescents
Objectives: to develop and validate self-report internet-based questionnaires for suicidal risk in children and adolescents specifically addressed to capture the possible influence of medication side-effects (The STOP scale: Suicidality Treatment Occurring in Pediatrics). The development of the instruments is part of the grant project STOP that responds to a specific call of the FP7 Cooperation Work Programme “HEALTH : Adverse drug reaction research’’.
The FINAL Medication
Side-Effects Suicidality Scale:
-Adolescents’ version
-Children’s version
-Parents’ version
-Clinicians’ version
Experts review
Panel of experts
Scientific Advisory
Board
Methods: The development of the instruments followed the Food and Drug Administration recommendations for Patient-Reported Outcome (PRO) instruments. A first draft was based on potential screening questions from scales such as the the UKU side effect rating scale about side effects that have been specifically associated with suicidality described in the literature, and expert opinion of child and adolescent psychiatrists. The final questionnaires were then administered to a sample of adolescents and children through the HealthTrackerTM(1), a web-based health monitoring system, to obtain data regarding test-retest reliability and internal consistency.
Example: Adolescents’ version
Results: The final STOP Medication Side-Effect Suicidality Scale for adolescents, parents and clinicians has 28 items with 5 response options, assessing side effects that have been specifically associated with suicidality and the scale for children consists of 21 items with simplified questions and 4 response options. The questionnaires were administered using the web-based HealthTrackerTM monitoring system.
94 adolescents and 53 children from Spain, Italy, France, Germany and UK answered the questionnaires online
Psychometric properties:CHILDREN
Psychometric properties:ADOLESCENTS
Cronbach’s
ALPHA
Test-Retest
Pearson’s r
CHILDREN
0.881
0.802
p<0.001
PARENTS
(Children)
0.940
0.698
CLINICIANS
0.817
0.809
Correlation of the instruments
PARENTS
CLINICIAN
CHILDREN
r=0.072
p=.618
r=0.311
p=.027
r=0.346
p=.014
Cronbach’s
ALPHA
Test-Retest
Pearson’s r
ADOLESCENTS
0.963
0.844
p<0.001
PARENTS
(Adolescents)
0.958
0.698
CLINICIANS
0.945
0.857
Correlation of the instruments
PARENTS
CLINICIAN
ADOLESCENT
r=0.448
p=0.000
r=0.715
r=0.591
Conclusions:
The newly developed web-based STOP Medication Side-Effect Suicidality Scales assess the possible relation of suicidality with medication side effects. The instruments for children and adolescents show high internal consistency and test-retest reliability.
The STOP scale will be tested in 3 paediatric observational trials with medication (fluoxetine, risperidone and montelukast) and standardized, which then they could be used in pharmacovigilance and in epidemiological, observational, and registration.
References
Gringras P, Santosh P, Baird G. Development of an Internet-based real-time system for monitoring pharmacological interventions in children with neurodevelopmental and neuropsychiatric disorders. Child Care Health Dev Sep;32(5):