Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04559633 |
Other study ID # |
RECHMPL20_0048 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 22, 2020 |
Est. completion date |
July 22, 2025 |
Study information
Verified date |
May 2024 |
Source |
University Hospital, Montpellier |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Anxious school refusal (ASR) is a common disorder which concerns more and more adolescents
who are at worse completely absent from school. A specific ambulatory cognitive and
behavioral therapy (CBT) program has been established to gradually reintegrate the child back
into the school environment with a multidisciplinary team. Alongside school reintegration
assessment, the child's overall ability to function and anxiety levels will be measured
before and after the program with additional assessments made after a further 6 and 12 months
have elapsed.
Description:
ASR concerns children and adolescents who feel anxiety about going to school. Some are
totally absent, some just have difficulty remaining in school for the entire day, or go to
school following behavioral problems such as morning tantrums or psychosomatic complaints.
Anxiety disorders are the main diagnostic underlying this behavioral problem, with one or
many anxiety disorders associated (i.e. separation anxiety disorder, panic disorder, social
anxiety disorder, generalized anxiety disorder or specific phobia). ASR causes much distress
to the child, the parents, and the school personnel and interferes with social and
educational development. Children with severe or chronic school refusal appear to have a
long-term risk of adult mental health issues (e.g. anxiety, depression). Studies about ASR
are few, and nonexistent in France. ASR occurs in approximately 1% of all school-aged
children, and 5% of all clinic-referred children, is equally common in both boys and girls
but more frequent in adolescents. Recommendations for anxiety disorder treatment in youth is
psychotherapy. CBT, especially exposure-based, is the intervention that is supported by
numerous, randomized, controlled trials in this area. But concerning ASR, there are few
studies.
A specific ambulatory therapeutic CBT program for totally absent from school adolescents is
established within the children and adolescent psychiatric unit in the University Hospital of
Montpellier, France. The unit has implemented CBT techniques to gradually reintegrate the
child back into the school environment. This program will be implemented in 3 other child and
adolescent psychiatry centers (Marseille, Béziers and Nîmes).
The main objective of this study is to evaluate the efficiency of a CBT program on the return
back to school.
Secondary objectives are:
1. To evaluate the feasibility in implantation of this program
2. To describe the characteristics of adolescents
3. To assess the initial severity of mental disorders and the evolution of these disorders
4. To describe the evolution of patient anxiety
5. To describe the evolution of the overall functioning
6. To evaluate the efficiency on the return back to school at 6 and 12 month after
intervention.