NCT04559633

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 22, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2024

Completed
Last Updated

July 18, 2024

Status Verified

May 1, 2024

Enrollment Period

2.7 years

First QC Date

August 18, 2020

Last Update Submit

July 17, 2024

Conditions

Keywords

Anxious school refusalanxiety disordersCBTtreatment outcomeadolescents

Outcome Measures

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

    46 months

Secondary Outcomes (8)

  • Types of anxiety disorders according to the DSM 5

    46 months

  • Presence of comorbidities

    46 months

  • Initial severity of mental disorders and the evolution of these disorders

    46 months

  • Anxiety assessment

    46 months

  • Anxiety assessment

    46 months

  • +3 more secondary outcomes

Study Arms (1)

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

Other: cognitive and behavioral therapy (CBT)

Interventions

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.

Anxious school refusal

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hélène DENIS

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2020

First Posted

September 23, 2020

Study Start

September 22, 2020

Primary Completion

May 22, 2023

Study Completion

July 8, 2024

Last Updated

July 18, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations