ClinicalTrials.gg
CompletedNCT04559633RSA-CollUpdated Jul 18, 2024

Cognitive and Behavioral Therapy in School Refusal

An interventional study of cognitive and behavioral therapy (CBT) in Child Psychiatry, Adolescent and Anxious School Refusal, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 10 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-07-18.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Not applicable
Ages
10 Years to 16 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

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

Browse trials for

Keywords

  • Anxious school refusal
  • anxiety disorders
  • CBT
  • treatment outcome
  • adolescents
03

In context

Anxiety Disorders

5,065 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.

This study's enrollment of 66 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 226 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • 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)

Interventions

  • Othercognitive 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 46 months

Secondary outcomes

  1. 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

    Time frame: 46 months

  2. 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

    Time frame: 46 months

  3. Initial severity of mental disorders and the evolution of these disorders

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

    Time frame: 46 months

  4. Anxiety assessment

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

    Time frame: 46 months

  5. Anxiety assessment

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

    Time frame: 46 months

  6. Anxiety assessment

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

    Time frame: 46 months

  7. Global functioning

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

    Time frame: 46 months

  8. School attendance time month by month

    Time frame: 46 months

07

Study locations

1 site
  • Montpellier University Hospital
    Montpellier, 34295, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04559633
Responsible party
Sponsor
First posted
Sep 23, 2020
Start date
Sep 22, 2020
Primary completion
May 22, 2023
Completion
Jul 8, 2024
Last update
Jul 18, 2024

Study contacts

Hélène DENIS
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion