Phone-Delivered Psychological Intervention (t-CETA) for Mental Health Problems in 8-17 Year-Old Syrian Refugee Children

NCT03887312 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-02-18

No results posted yet for this study

Summary

This study evaluates the effectiveness of t-CETA, a version of Common Elements Treatment Approach (CETA) adapted to be delivered over the telephone, in treating common mental health problems in 8-17 year old Syrian refugee children living in Lebanon. Children will be randomly assigned to receive either t-CETA or treatment as usual provided by Médecins du Monde, an NGO providing medical and mental health services to Syrian refugees in Lebanon. If families do not agree to randomisation, they will be offered t-CETA and their data will be used to evaluate implementation and acceptability of the intervention.

Symptoms of common mental health problems, including anxiety, depression, PTSD, and behavioural problems, and psychological well-being, will be measured before treatment, immediately after treatment, and three months after treatment is completed. Groups will be compared to determine if t-CETA is at least as effective as standard treatment provided by Médecins du Monde.

Conditions

Interventions

BEHAVIORAL

t-CETA

Cognitive Behavioural Therapy (CBT) based approach delivered over the telephone. Components are available for common problems, including anxiety, depression, PTSD, conduct problems, substance abuse, and safety issues (including self-harm or suicidal ideation), and a tailored treatment package is produced for each child based on the presenting problem(s) and response to treatment. There are components for use with both child and caregiver.

BEHAVIORAL

Médecins du Monde treatment as usual

Case manager-led care, with referral to a psychotherapist or psychiatrist as necessary. Médecins du Monde's approach is based on a joint collaboration between mental health trained case managers (who undergo extensive training by experts in the field on topics including Psychological First Aid, Child Protection, Gender Based Violence, etc.) and psychotherapists from different schools (providing Eye Movement Desensitization and Reprocessing \[EMDR\] for trauma, Interpersonal Therapy \[IPT\] for depression, Cognitive Behavioural Therapy \[CBT\], motivational counselling, familial or systemic therapy, and integrative approaches). Thus the number and content of sessions, and the person delivering treatment (case manager, psychotherapist, psychiatrist) vary.

Sponsors & Collaborators

  • Médecins du Monde

    collaborator OTHER
  • American University of Beirut Medical Center

    collaborator OTHER
  • Johns Hopkins University

    collaborator OTHER
  • Medical School Hamburg

    collaborator OTHER
  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Michael Pluess, PhD · Queen Mary University of London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Lebanon

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03887312 on ClinicalTrials.gov