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

Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention (t-CETA) for Syrian Refugee Children in Lebanon: Phase II - t-CETA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
LBCTR
Registry ID
LBCTR2019040213
Enrollment
120
Registered
2020-02-17
Start date
2019-05-14
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, anxiety, PTSD, conduct disorder, oppositional defiant disorder Depression Anxiety PTSD Conduct disorder Oppositional defiant disorder

Interventions

1. Telephone-delivered Common Elements Treatment Approach (t-CETA) [EXPERIMENTAL ARM] Cognitive Behavioural Therapy (CBT) based approach delivered over the telephone. Components are available for com
Telephone-delivered Common Elements Treatment Approach (t-CETA). Cognitive Behavioural Therapy (CBT) based approach delivered over the telephone. Components are available for common problems, includin
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
CBT
cognitive behavioral therapy
telephone delivered therapy
Case manager-led care
psychotherapy

Sponsors

Queen Mary University of London
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Age 8-17 years, male or female 2. Live with a parent or other legal guardian 3. Child and/or parent identifies that the child has mental health difficulties and requests services 4. 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] 5. 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 6. Parent/legal guardian gives informed consent and child gives assent to take part

Exclusion criteria

Exclusion criteria: 1. 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) 2. Parent or legal guardian is not able to provide consent 3. Child protection issues (e.g., acute maltreatment) that are judged by clinician to make trial inclusion inappropriate 4. Any inclusion criteria not met

Design outcomes

Primary

MeasureTime frame
Name: Emotional and behavioural problem composite score;Timepoints: 1. Baseline (pre-treatment); 2. Approximately 12 weeks (immediately after treatment has been completed); 3. Approximately 24 weeks (3 months following completion of treatment);Measure: Measures common emotional and behavioural problems in children. Scores from the following questionnaire measures will be aggregated: Child PTSD Symptom Scale (CPSS; child self-report), Center for Epidemiological Studies Depression Scale for Children (CES-DC; child self-report), Screen for Child Anxiety Related Emotional Disorders (SCARED; child self-report), the Strengths and Difficulties Questionnaire (SDQ; parent report) externalising score, and conduct disorder / oppositional defiant disorder items (caregiver report). Arabic versions of all questionnaires are used. Scores on these questionnaires have been divided into deciles based on data from the population from which the study sample is drawn and each decile is converted into a score ranging from 0 (lowest decile) to 9 (highest decile). These decile scores are then summed for the four questionnaire measures, giving a total score ranging from 0 to 36. Higher scores indicate greater problems.;Name: World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): child report;Timepoints: 1. Baseline (pre-treatment); 2. Approximately 12 weeks (immediately after treatment has been completed); 3. Approximately 24 weeks (3 months following completion of treatment);Measure: WHODAS-child orginally adapted for Rwanda and then translated into Arabic for use with Syrian children (child self-report). Measures three domains of functional impairment: getting along with people, life activities (ability to carry out responsibilities at home and school), and participation in society (ability to engage in community, civil and recreational activities). Subscales are averaged to produce a Global Disability score. Scores are expressed as a percentage so

Secondary

MeasureTime frame
Name: Child PTSD Symptom Scale (CPSS);Timepoints: 1. Baseline (pre-treatment); 2. Approximately 12 weeks (immediately after treatment has been completed); 3. Approximately 24 weeks (3 months following completion of treatment);Measure: Child PTSD Symptom Scale, Arabic version, child self-report. Total post-traumatic stress disorder symptom scores range from 0-51 and higher scores indicate a higher level of symptoms.;Name: Center for Epidemiological Studies Depression Scale for Children (CES-DC);Timepoints: 1. Baseline (pre-treatment); 2. Approximately 12 weeks (immediately after treatment has been completed); 3. Approximately 24 weeks (3 months following completion of treatment);Measure: Center for Epidemiological Studies Depression Scale for Children, Arabic 10-item version, child-self-report. Total depression symptom scores range from 0-30 and higher scores indicate a higher level of symptoms.;Name: Screen for Child Anxiety Related Emotional Disorders (SCARED);Timepoints: 1. Baseline (pre-treatment); 2. Approximately 12 weeks (immediately after treatment has been completed); 3. Approximately 24 weeks (3 months following completion of treatment);Measure: Screen for Child Anxiety Related Emotional Disorders, Arabic 18-item version, child-self-report. Total anxiety symptoms scores range from 0-36 and higher scores indicate a higher level of symptoms.;Name: Externalising behaviour problems score;Timepoints: 1. Baseline (pre-treatment); 2. Approximately 12 weeks (immediately after treatment has been completed); 3. Approximately 24 weeks (3 months following completion of treatment);Measure: Score derived from the Strengths and Difficulties Questionnaire (SDQ; parent-report) externalising score (10 items) and items measuring behaviours associated with conduct disorder (CD) and oppositional defiant disorder (ODD) (12 items). Arabic version, caregiver report. The SDQ externalising score ranges from 0-20 and the CD/ODD items range from 0-24. These will be summed to given an

Countries

Lebanon

Contacts

Public ContactTania Bosqui

American University of Beirut

tb33@aub.edu.lb+9611350000 ext:4370

Outcome results

None listed

Source: LBCTR (via WHO ICTRP) · Data processed: Feb 7, 2026