RSA-Coll: Cognitive and Behavioral Therapy in School Refusal

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04559633
Collaborator
(none)
70
1
1
58
1.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: cognitive and behavioral therapy (CBT)
N/A

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:
  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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Anxious School Refusal in Adolescents: Efficiency of a Cognitive and Behavioral Therapy (CBT) Day Hospital Program
Actual Study Start Date :
Sep 22, 2020
Anticipated Primary Completion Date :
Sep 22, 2023
Anticipated Study Completion Date :
Jul 22, 2025

Arms and Interventions

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

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.

Outcome Measures

Primary Outcome Measures

  1. School continue reintegration [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

Secondary Outcome Measures

  1. Types of anxiety disorders according to the DSM 5 [46 months]

    The questionnaire Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-S KID) is completed with parents and the adolescent

  2. Presence of comorbidities [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

  3. Initial severity of mental disorders and the evolution of these disorders [46 months]

    Mesure thanks to the Clinical Global Impression (CGI) scale.

  4. Anxiety assessment [46 months]

    Mesure thanks to the Anxiety and Phobia Behavioural (ECAP) Scale

  5. Anxiety assessment [46 months]

    Mesure thanks to the scales Revisited Children's Manifest Anxiety scale (RCMAS)

  6. Anxiety assessment [46 months]

    Mesure thanks to the scales Multidimensional Anxiety Scale for Children (MASC)

  7. Global functioning [46 months]

    Mesure thanks to the scale Children's global Assessment (C GAS) Scale

  8. School attendance time month by month [46 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Montpellier University Hospital Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

  • Principal Investigator: Hélène DENIS, Montpellier University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT04559633
Other Study ID Numbers:
  • RECHMPL20_0048
First Posted:
Sep 23, 2020
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier

Study Results

No Results Posted as of Apr 22, 2022