Child PsychiatryRSA-CollNCT04559633
Cognitive and Behavioral Therapy in School Refusal
A study testing cognitive and behavioral therapy (CBT) in people with Child Psychiatry and Adolescent, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Child Psychiatry, Adolescent, Anxious School Refusal
- What is being tested?
- cognitive and behavioral therapy (CBT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2020to 8 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anxious School Refusal in Adolescents: Efficiency of a Cognitive and Behavioral Therapy (CBT) Day Hospital Program
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:
- 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.
- Being tested
- cognitive and behavioral therapy (CBT)
- Keywords
- Anxious school refusal, anxiety disorders, CBT, treatment outcome, adolescents
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive and behavioral therapy (CBT)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.
| Study group | Role | What they receive |
|---|---|---|
| Anxious school refusal | Experimental | Adolescents with anxious shool refusal will beneficiate of cognitive and behavioral therapy (CBT) in order to help them to return back to school Receives: Other: cognitive and behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 46 months
Secondary outcomes (8)
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
Measured: 46 months
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
Measured: 46 months
Initial severity of mental disorders and the evolution of these disorders
Mesure thanks to the Clinical Global Impression (CGI) scale.
Measured: 46 months
Anxiety assessment
Mesure thanks to the Anxiety and Phobia Behavioural (ECAP) Scale
Measured: 46 months
Anxiety assessment
Mesure thanks to the scales Revisited Children's Manifest Anxiety scale (RCMAS)
Measured: 46 months
Anxiety assessment
Mesure thanks to the scales Multidimensional Anxiety Scale for Children (MASC)
Measured: 46 months
Global functioning
Mesure thanks to the scale Children's global Assessment (C GAS) Scale
Measured: 46 months
School attendance time month by month
Measured: 46 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start22 Sep 2020
- Primary completion22 May 2023
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child PsychiatryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène DENIS, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559633
- Sponsor's protocol ID
- RECHMPL20_0048
- Acronym
- RSA-Coll
- Status last verified
- May 2024
- First submitted
- 18 Aug 2020
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxious School Refusal in Adolescents: Efficiency of a Cognitive and Behavioral Therapy (CBT) Day Hospital Program
- ClinicalTrials.gov ID
- NCT04559633
- Acronym / sponsor ID
- RSA-Coll / RECHMPL20_0048
- Keywords
- Anxious school refusal, anxiety disorders, CBT, treatment outcome, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anxious school refusal | Experimental | Other: cognitive and behavioral therapy (CBT)Adolescents with anxious shool refusal will beneficiate of cognitive and behavioral therapy (CBT) in order to help them to return back to school |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Anxious school refusal |
Primary outcome
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
8 secondary outcomes
Types of anxiety disorders according to the DSM 5
Time frame: 46 months
Presence of comorbidities
Time frame: 46 months
Initial severity of mental disorders and the evolution of these disorders
Time frame: 46 months
Anxiety assessment
Time frame: 46 months
Anxiety assessment
Time frame: 46 months
Anxiety assessment
Time frame: 46 months
Global functioning
Time frame: 46 months
School attendance time month by month
Time frame: 46 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène DENIS principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive and behavioral therapy (CBT) in people with Child Psychiatry and Adolescent, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School continue reintegration (time frame: 46 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.