Cognitive and Behavioral Therapy in School Refusal

Adolescent Clinical Trial

— RSA-Coll  

Official title:

Anxious School Refusal in Adolescents: Efficiency of a Cognitive and Behavioral Therapy (CBT) Day Hospital Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04559633
• Other study ID #: RECHMPL20_0048
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2020
• Est. completion date: July 22, 2025

Study information

• Verified date: April 2022
• Source: University Hospital, Montpellier
• Contact: Hélène DENIS, PhD
• Phone: 467339688
• Email: h-denis[@]chu-montpellier.fr
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 70
• Est. completion date: July 22, 2025
• Est. primary completion date: September 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

Related Conditions & MeSH terms

• Adolescent
• Anxious School Refusal
• Child Psychiatry
• Cognitive Behavioral Therapy

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