Authors
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Queen Mary University of London -More
Category
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Primary study
Registry of Trials»Lebanese Clinical Trials Registry
Year
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2019
INTERVENTION: 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 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 8‐16 weeks. The number and content of sessions will be tailored to each child, thus there will be some variation. 2. Médecins du Monde treatment as usual [ACTIVE COMPARATOR ARM] 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). The number and content of sessions, and the person delivering treatment (case manager, psychotherapist, psychiatrist) vary. Treatment as usual provided by Médecins du Monde. The number and content of sessions will vary depending on the needs of the child. 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 fiel Case manager‐led care; psychotherapy t‐CETA; CBT; cognitive behavioral therapy; telephone delivered therapy 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, sub CONDITION: 2568 2605 2614 2792 2796 Anxiety Conduct disorder Depression Depression, anxiety, PTSD, conduct disorder, oppositional defiant disorder ; Depression ; Anxiety ; PTSD ; Conduct disorder ; Oppositional defiant disorder Oppositional defiant disorder PTSD SECONDARY OUTCOME: 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: 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: Client Monitoring Form (CMF);Timepoints: 1. Baseline (pre‐treatment); 2. Approximately 12 weeks (at final treatment session);Measure: Client Monitoring Form developed for this study to measure mental health problems, substance use, and safety issues during treatment, Arabic version, child self‐report. 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 externalising behaviour problems score ranging from 0‐44 and higher scores indicate a higher level of problems. Name: PSYCHLOPS During Therapy (Kids or Teen);Timepoints: At mid‐point treatment session, approximately 5‐6 weeks after baseline;Measure: Psychological Outcome Profiles (PSYCHLOPS) During Therapy, Kids version (for children aged 8‐12 years), Teen version (for age 13‐16 years). Arabic version, child self‐report. Three subscale scores are used, Problems (range 0‐4 [Kids], 0‐10 [Teen]), Functioning (range 0‐4 [Kids], 0‐5 [Teen]), and Wellbeing (range 0‐4 [Kids], 0‐5 [Teen]). These are summed to give a total score (range 0‐12 [Kids], 0‐20 [Teen]). Scores from the Kids version will be scaled to be equivalent to the Teen version so scores are comparable across both age groups. Higher scores indicate greater problems, impaired functioning, and poorer wellbeing. Name: PSYCHLOPS Post‐Therapy (Kids or Teen);Timepoints: At final treatment session, approximately 8‐12 weeks after baseline;Measure: Psychological Outcome Profiles (PSYCHLOPS) Post‐Therapy, Kids version (for children aged 8‐12 years), Teen version (for age 13‐16 years). Arabic version, child self‐report. Three subscale scores are used, Problems (range 0‐4 [Kids], 0‐10 [Teen]), Functioning (range 0‐4 [Kids], 0‐5 [Teen]), and Wellbeing (range 0‐4 [Kids], 0‐5 [Teen]). These are summed to give a total score (range 0‐12 [Kids], 0‐20 [Teen]). Scores from the Kids version will be scaled to be equivalent to the Teen version so scores are comparable across both age groups. Higher scores indicate greater problems, impaired functioning, and poorer wellbeing. Name: PSYCHLOPS Pre‐Therapy (Kids or Teen);Timepoints: At first treatment session, approximately 1‐2 weeks after baseline;Measure: Psychological Outcome Profiles (PSYCHLOPS) Pre‐Therapy, Kids version (for children aged 8‐12 years), Teen version (for age 13‐16 years). Arabic version, child self‐report. Three subscale scores are used, Problems (range 0‐4 [Kids], 0‐10 [Teen]), Functioning (range 0‐4 [Kids], 0‐5 [Teen]), and Wellbeing (range 0‐4 [Kids], 0‐5 [Teen]). These are summed to give a total score (range 0‐12 [Kids], 0‐20 [Teen]). Scores from the Kids version will be scaled to be equivalent to the Teen version so scores are comparable across both age groups. Higher scores indicate greater problems, impaired functioning, and poorer wellbeing. 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: WHO‐5 Well‐Being Index (WHO‐5);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: WHO‐5 Well‐Being Index, Arabic version, child‐self‐report. Total well‐being scores range from 0‐100 and higher scores indicate higher well‐being. Name: Youth Life Orientation Test (YLOT);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: Youth Life Orientation Test, measuring optimism, Arabic 4‐item version, child self‐report. Total optimism scores range from 0‐12 and higher scores indicate higher optimism. 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 clinic PRIMARY OUTCOME: 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): caregiver 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 (caregiver 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 range from 0‐100, with higher scores indicating greater impairment. 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 range from 0‐100, with higher scores indicating greater impairment.
Epistemonikos ID: 9366bb71ec20d7bba9b180c6a9ab44f5d9269ce7
First added on: Aug 24, 2024