Cognitive and Behavioral Therapy in School Refusal

NCT ID: NCT04559633

Last Updated: 2024-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-22

Study Completion Date

2024-07-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Child Psychiatry Adolescent Anxious School Refusal Cognitive Behavioral Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

cognitive and behavioral therapy (CBT)

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hélène DENIS

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Montpellier University Hospital

Montpellier, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RECHMPL20_0048

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

School Withdrawal in Adolescents
NCT03904784 TERMINATED