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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05432323
Other study ID # APHP211594
Secondary ID 2021-A01853-38
Status Recruiting
Phase
First received
Last updated
Start date September 12, 2022
Est. completion date June 2026

Study information

Verified date March 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Aurélie HARF, MD, PhD
Phone 0033158413440
Email aurelie.harf@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine whether multi-family therapy is effective in the treatment of school refusal with anxiety in adolescence.


Description:

Anxious school refusal in adolescence is a major public health problem. The involvement of families is essential and multi-family therapy has shown its effectiveness for many mental disorders. This study aims to explore the benefit of multi-family therapy in the care of anxious school refusal in adolescence. The method will be qualitative with phenomenological analysis of semi-structured interviews with adolescents and their parents and quantitative with a SCED design to assess the evolution of the level of anxiety of adolescents and parents, as well as personalized objectives. The objective is therefore to improve the care of adolescents with anxious school refusal.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date June 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: - Families with an adolescent - Aged 12 to 18 - Totally out of school for more than 2 consecutive weeks and less than 18 months - Follow-up at the Maison de Solenn-Maison des Adolescents (Cochin Hospital AP-HP) for a school refusal - Having agreed to participate in a multi-family therapy - Domiciliation in Ile de France - Agreement of the parents and the adolescent to participate in the study: Collection of the non-opposition of non-emancipated minors and their legal representatives Exclusion Criteria: - any family situation that makes it impossible to bring parents and children together in family therapy - patient under curatorship or tutorship - patient with AME (french State Medical Aid)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Multi-family therapy
8 sessions of Multi-family therapy of 3 hours each during 24 weeks

Locations

Country Name City State
France Maison de Solenn Maison des Adolescents, Cochin Hospital Paris IDF

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale (VAS) Visual Analogue Scale for anxiety (adolescents and parents) / 0 = no anxiety at all, 10 = maximum anxiety imaginable / Weekly measurement between inclusion and the end of the Single Case Experimental Design (SCED) follow-up (13 to 15 months) 13 to 15 months
Secondary Goal Attainment Scale (GAS) School attendance (adolescent) / 3-terminal GAS are 5-level GAS, i.e. with a possible rating ranging from -2 to +2. Level -2 corresponds to the initial state at the time of inclusion. Levels -2, 0 and +2 are precisely described, level -1 corresponds to a rating between -2 and 0 and level +1 to a rating between 0 and +2 / Weekly measurements, parents and adolescent, once a week from inclusion to the end of the SCED follow-up (13 to 15 months) 13 to 15 months
Secondary Adolescent Depression Rating Scale (ADRS) Depression (adolescent) / 10 questions / Monthly measurements, adolescent and referring psychiatrist once a month from inclusion to the end of the SCED follow-up (13 to 15 months) 13 to 15 months
Secondary Family Assessment Device General Functioning (FAD-GF) Family functioning / 12 questions, minimum = 12, maximum = 48 / Monthly measurements, parents and adolescent, once a month from inclusion to the end of the SCED follow-up (13 to 15 months) 13 to 15 months
Secondary Global Assessment of Functioning Scale (GAF) Global Functioning of the adolescent / From 0 = inadequate information, to 100 = higher level of functioning in a wide variety of activities - V-axis of the DSM 5 / Monthly measurements, referring psychiatrist, once a month from inclusion to the end of the SCED follow-up (13 to15 months) 13 to 15 months
Secondary CSQ 8 (Client Satisfaction Questionnaire) Satisfaction of the patients and the parents with multi-family therapy / 8 questions, minimum score = 8, maximum = 32 / At the end of the multifamily therapy, parents and teenager 7 to 9 months
Secondary Semi-structured interview Semi-structured interview with qualitative phenomenological analysis (patients and parents) At the end of multi-family therapy 7 to 9 months
Secondary Semi-structured interview Semi-structured interview with qualitative phenomenological analysis (patients and parents) 12 months after the end of multi-family therapy 19 to 21 months
See also
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