- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04559633
Cognitive and Behavioral Therapy in School Refusal (RSA-Coll)
Anxious School Refusal in Adolescents: Efficiency of a Cognitive and Behavioral Therapy (CBT) Day Hospital Program
Study Overview
Status
Intervention / Treatment
Detailed 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:
- To evaluate the feasibility in implantation of this program
- To describe the characteristics of adolescents
- To assess the initial severity of mental disorders and the evolution of these disorders
- To describe the evolution of patient anxiety
- To describe the evolution of the overall functioning
- To evaluate the efficiency on the return back to school at 6 and 12 month after intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Montpellier, France, 34295
- Montpellier University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Anxious school refusal
Adolescents with anxious shool refusal will beneficiate of cognitive and behavioral therapy (CBT) in order to help them to return back to school
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
School continue reintegration
Time Frame: 46 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Types of anxiety disorders according to the DSM 5
Time Frame: 46 months
|
The questionnaire Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-S KID) is completed with parents and the adolescent
|
46 months
|
|
Presence of comorbidities
Time Frame: 46 months
|
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
|
|
Initial severity of mental disorders and the evolution of these disorders
Time Frame: 46 months
|
Mesure thanks to the Clinical Global Impression (CGI) scale.
|
46 months
|
|
Anxiety assessment
Time Frame: 46 months
|
Mesure thanks to the Anxiety and Phobia Behavioural (ECAP) Scale
|
46 months
|
|
Anxiety assessment
Time Frame: 46 months
|
Mesure thanks to the scales Revisited Children's Manifest Anxiety scale (RCMAS)
|
46 months
|
|
Anxiety assessment
Time Frame: 46 months
|
Mesure thanks to the scales Multidimensional Anxiety Scale for Children (MASC)
|
46 months
|
|
Global functioning
Time Frame: 46 months
|
Mesure thanks to the scale Children's global Assessment (C GAS) Scale
|
46 months
|
|
School attendance time month by month
Time Frame: 46 months
|
46 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hélène DENIS, Montpellier University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RECHMPL20_0048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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