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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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 66
Est. completion date July 22, 2025
Est. primary completion date May 22, 2023
Accepts healthy volunteers No
Gender All
Age group 10 Years to 16 Years
Eligibility Inclusion criteria: - Adolescents between 10 and 16 years old registered in French college (6è to 3è), - Anxious school refusal based on Berg's criteria, - Completely dropped out from school (>5 consecutive days of school nonattendance, absenteeism < 12 months), - Anxiety disorder as a principal diagnosis (DSM 5)(MINI -S KID), - Adolescents want to return to school, - Signed consent by parents and adolescents Exclusion criteria: - Intellectual disabilities - Autism spectrum disorder - Learning disabilities that causes emotional trouble and being the primary cause of teenagers dropping out of school. - Conduct disorder (DSM 5) - Ongoing psychotherapeutic care that the parents or the adolescent would not wish to suspend - Participation in other ongoing research - Pregnancy - Patient not benefiting from a social security scheme

Study Design


Intervention

Other:
cognitive and behavioral therapy (CBT)
The CBT program is delivered by a multidisciplinary team with 4 half day hospitalization that includes individual, group CBT and education time (2 hours per day delivered by the teacher). Participants have homework to do in their own time at home. CBT is a manualized program with anxiety psychoeducation, stress management, cognitive restructuration, problem solving techniques, progressive exposure, assertiveness exercises and self-esteem work.

Locations

Country Name City State
France Montpellier University Hospital Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary School continue reintegration The return back to school next year : school continue reintegration (number of hours the adolescent attended school > 80% of the number of hours expected for each patient 46 months
Secondary Types of anxiety disorders according to the DSM 5 The questionnaire Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-S KID) is completed with parents and the adolescent 46 months
Secondary Presence of comorbidities Presence of comorbidities is evaluated by the questionnaire Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-S KID) completed with parents and the adolescent 46 months
Secondary Initial severity of mental disorders and the evolution of these disorders Mesure thanks to the Clinical Global Impression (CGI) scale. 46 months
Secondary Anxiety assessment Mesure thanks to the Anxiety and Phobia Behavioural (ECAP) Scale 46 months
Secondary Anxiety assessment Mesure thanks to the scales Revisited Children's Manifest Anxiety scale (RCMAS) 46 months
Secondary Anxiety assessment Mesure thanks to the scales Multidimensional Anxiety Scale for Children (MASC) 46 months
Secondary Global functioning Mesure thanks to the scale Children's global Assessment (C GAS) Scale 46 months
Secondary School attendance time month by month 46 months
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