NCT05432323

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress96%
Sep 2022Jul 2026

First Submitted

Initial submission to the registry

June 14, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 12, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2024

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

June 14, 2022

Last Update Submit

September 5, 2025

Conditions

Keywords

AdolescenceSchool PhobiaMulti-family therapyAnxiety disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Goal Attainment Scale (GAS)

    13 to 15 months

  • Adolescent Depression Rating Scale (ADRS)

    13 to 15 months

  • Family Assessment Device General Functioning (FAD-GF)

    13 to 15 months

  • Global Assessment of Functioning Scale (GAF)

    13 to 15 months

  • CSQ 8 (Client Satisfaction Questionnaire)

    7 to 9 months

  • +2 more secondary outcomes

Study Arms (2)

Adolescents

Behavioral: Multi-family therapy

Parents

Behavioral: Multi-family therapy

Interventions

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

AdolescentsParents

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Cochin Hospital, Maison de Solenn-Maison des Adolescents, Paris, AP-HP Primary care clinic, Day care clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maison de Solenn Maison des Adolescents, Cochin Hospital

Paris, IDF, 75014, France

Location

MeSH Terms

Conditions

Phobia, SchoolAnxiety Disorders

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Phobic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marie-Rose MORO, MD, PhD, PU-PH

    Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

    STUDY DIRECTOR
  • Aurélie HARF, MD, PhD

    Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2022

First Posted

June 27, 2022

Study Start

September 12, 2022

Primary Completion

March 2, 2024

Study Completion (Estimated)

July 1, 2026

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations