NCT03887312.
| Study name | Phone‐delivered psychological intervention (t‐CETA) for mental health problems in 8‐17 year‐old Syrian refugee children (t‐CETA) |
| Methods |
Study design: RCT Country: Lebanon |
| Participants | Syrian refugee children and adolescents (8‐17 year‐olds) Inclusion criteria: a. aged 8‐17 years, male or female; b. llve with a parent or other legal guardian; c. child and/or parent identifies that the child has mental health difficulties and requests services; d. at high risk of having a mental disorder as indexed by falling in the top 40% of the distribution in any one of the following child‐report questionnaires: (i) Screen for Child Anxiety Related Emotional Disorders (SCARED), (ii) Center for Epidemiological Studies Depression Scale for Children (CES‐DC), (iii) Child PTSD Symptom Scale (CPSS); AND falling in the top 40% of the distribution in the following parent report questionnaire: Strengths and Difficulties Questionnaire (SDQ) total difficulties [criterion 4 is only applicable to children for whom these data are available from participation in the BIOPATH study; criterion 5 takes precedence over criterion 4 where both are available]; e. confirmation of significant level of symptoms and functional impairment on clinical interview (MINI KID) as indicated by (i) meeting full or probable diagnostic criteria for ANY of the following: any category of mood disorder, any category of anxiety disorder, PTSD, conduct disorder, or oppositional defiant disorder; AND (ii) Clinical Global Impression severity (CGI‐s) score of > 3; f. parent/legal guardian gives informed consent and child gives assent to take part. Exclusion criteria: a. problem for which t‐CETA would not be appropriate, including psychiatric disorders for which CETA treatment is not recommended (e.g. bipolar disorder, psychosis), severe distress (e.g. acute suicidal ideation), or problems that would preclude delivery over the telephone (e.g. selective mutism); b. parent or legal guardian is not able to provide consent; c. child protection issues (e.g. acute maltreatment) that are judged by clinician to make trial inclusion inappropriate; d. any inclusion criteria not met. Stated purpose: 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 |
| Interventions |
Intervention: Telephone‐delivered Common Elements Treatment Approach (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. t‐CETA sessions of up to 30 minutes will be delivered 1‐2 times per week for approximately 8‐12 weeks. The number and content of sessions will be tailored to each child, thus there will be some variation. Control: Usual care (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). |
| Outcomes |
Participants'outcomes of interest for this review
Economic outcomes Nil Time points: baseline, post‐intervention (immediately after intervention and 3 months post‐intervention) |
| Starting date | 1 May 2019 Completed (31 January 2020) |
| Contact information | Michael Pluess, m.pluess@qmul.ac.uk |
| Notes |
Source of funding: no clear specification for funding Prospective trial registration number: NCT03887312 |