Multi-Fast: Multi-family Therapy and School Refusal: an Exploratory Study With Adolescents and Their Families

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05432323
Collaborator
(none)
28
1
39
0.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Multi-family therapy

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
28 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multi-family Therapy and School Refusal: an Exploratory Study With Adolescents and Their Families
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Adolescents

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

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale (VAS) [13 to 15 months]

    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)

Secondary Outcome Measures

  1. Goal Attainment Scale (GAS) [13 to 15 months]

    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)

  2. Adolescent Depression Rating Scale (ADRS) [13 to 15 months]

    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)

  3. Family Assessment Device General Functioning (FAD-GF) [13 to 15 months]

    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)

  4. Global Assessment of Functioning Scale (GAF) [13 to 15 months]

    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)

  5. CSQ 8 (Client Satisfaction Questionnaire) [7 to 9 months]

    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

  6. Semi-structured interview [7 to 9 months]

    Semi-structured interview with qualitative phenomenological analysis (patients and parents) At the end of multi-family therapy

  7. Semi-structured interview [19 to 21 months]

    Semi-structured interview with qualitative phenomenological analysis (patients and parents) 12 months after the end of multi-family therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maison de Solenn Maison des Adolescents, Cochin Hospital Paris IDF France 75014

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Marie-Rose MORO, MD, PhD, PU-PH, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
  • Principal Investigator: Aurélie HARF, MD, PhD, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT05432323
Other Study ID Numbers:
  • APHP211594
  • 2021-A01853-38
First Posted:
Jun 27, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2022