The goal of this study is to develop a low burden, reliable and efficient screening tool for suicidal ideation and suicide risk in children and adolescents specifically addressed to capture the possible influence of medication side effects or…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Psychiatrische aandoeningen waarvoor een anti-psychoticum of anti-depressiva wordt voorgeschreven
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The goal of this study is to develop a reliable and efficient screening tool
for suicidal ideation and suicide risk in children and adolescents specifically
addressed to capture the possible influence of medication side effects or
mechanism of action. The rating scale will have one form for children and
adolescents, one form to be addressed to their parents and another form to be
completed by the clinician.
Secondary outcome
More specifically, the objectives are:
1. To design a rating scale for assessing suicidality in children and
adolescents including developing different versions for children, parents, and
clinicians
2. To translate the rating scales into all the languages of the countries
collaborating in the study and to carry out a first evaluation of the
psychometric properties of the resulting scales.
Background summary
There is insufficient data available safety of using many medications in
children and adolescents who may have illness that itself predispose them to
suicidality. There is also insufficient data available about the time-course
about medication related suicidality and what happens to it over the long-term.
Further, there is insufficient data available about the long-term safety,
especially about medication related suicidality, especially since there is
evidence to suggest that paediatric populations may represent a vulnerable
group, compared to adults.
Study objective
The goal of this study is to develop a low burden, reliable and efficient
screening tool for suicidal ideation and suicide risk in children and
adolescents specifically addressed to capture the possible influence of
medication side effects or mechanism of action.
Study design
Questionnaire Validation
Study burden and risks
The compilation of new questionnaires should not result in additional risks to
the patient. Indeed an assessment of suicidality (i.e. asking the child if
he/she had now or in the past, ideas or behaviors related to suicide, the
circumstances and severity of damage) is always carried out in all patients
when performing clinical evaluation that leads to the diagnosis.
A direct benefit to the participants may result in a more accurate assessment
of suicidal symptoms, if any, that may be useful for better planning of
treatment.
Indirect benefits will be to help create a scale that will be used in different
types of psychopharmacological studies, allowing the collection of better data
about drug-related suicidality in children.
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
Children and adolescents between the ages of 8 and 18 years old, and their parents or main carer.
Children and adolescents newly treated with an antidepressant or cognitive behavior therapy for depression or antipsychotic medication for any indication (this inclusion criteria is for clinical population only).
All parents and patients have provided informed consent/assent in accordance with ethical regulations.
Exclusion criteria
If the main carer does not have a reasonable level of Dutch, they will be excluded from the study. This is because a reasonable level of Dutch is required to complete the baseline information.
Children who are deemed by the clinician to be too vulnerable to participate (for clinical population only).
The child/adolescent will be excluded if the main carer is not available to participate in the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44194.091.13 |