Depression Clinical Trial
— t-CETAOfficial title:
Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention (t-CETA) for Syrian Refugee Children in Lebanon: Phase II
Verified date | February 2020 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | January 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 17 Years |
Eligibility |
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: 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 |
Country | Name | City | State |
---|---|---|---|
Lebanon | Medecins du Monde | Beirut |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London | American University of Beirut Medical Center, Johns Hopkins University, Médecins du Monde, Medical School Hamburg |
Lebanon,
Bolton P, Lee C, Haroz EE, Murray L, Dorsey S, Robinson C, Ugueto AM, Bass J. A transdiagnostic community-based mental health treatment for comorbid disorders: development and outcomes of a randomized controlled trial among Burmese refugees in Thailand. PLoS Med. 2014 Nov 11;11(11):e1001757. doi: 10.1371/journal.pmed.1001757. eCollection 2014 Nov. — View Citation
Murray LK, Dorsey S, Haroz E, Lee C, Alsiary MM, Haydary A, Weiss WM, Bolton P. A Common Elements Treatment Approach for Adult Mental Health Problems in Low- and Middle-Income Countries. Cogn Behav Pract. 2014 May;21(2):111-123. — View Citation
Murray LK, Hall BJ, Dorsey S, Ugueto AM, Puffer ES, Sim A, Ismael A, Bass J, Akiba C, Lucid L, Harrison J, Erikson A, Bolton PA. An evaluation of a common elements treatment approach for youth in Somali refugee camps. Glob Ment Health (Camb). 2018 Apr 25;5:e16. doi: 10.1017/gmh.2018.7. eCollection 2018. — View Citation
Weiss WM, Murray LK, Zangana GA, Mahmooth Z, Kaysen D, Dorsey S, Lindgren K, Gross A, Murray SM, Bass JK, Bolton P. Community-based mental health treatments for survivors of torture and militant attacks in Southern Iraq: a randomized control trial. BMC Psychiatry. 2015 Oct 14;15:249. doi: 10.1186/s12888-015-0622-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Emotional and behavioural problem composite score | 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. | Baseline (pre-treatment) | |
Primary | Emotional and behavioural problem composite score | 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. | Approximately 12 weeks (immediately after treatment has been completed) | |
Primary | Emotional and behavioural problem composite score | 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. | Approximately 24 weeks (3 months following completion of treatment) | |
Primary | World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): child report | 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. | Baseline (pre-treatment) | |
Primary | World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): child report | 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. | Approximately 12 weeks (immediately after treatment has been completed) | |
Primary | World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): child report | 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. | Approximately 24 weeks (3 months following completion of treatment) | |
Primary | World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): caregiver report | 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. | Baseline (pre-treatment) | |
Primary | World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): caregiver report | 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. | Approximately 12 weeks (immediately after treatment has been completed) | |
Primary | World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): caregiver report | 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. | Approximately 24 weeks (3 months following completion of treatment) | |
Secondary | Child PTSD Symptom Scale (CPSS) | 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. | Baseline (pre-treatment) | |
Secondary | Child PTSD Symptom Scale (CPSS) | 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. | Approximately 12 weeks (immediately after treatment has been completed) | |
Secondary | Child PTSD Symptom Scale (CPSS) | 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. | Approximately 24 weeks (3 months following completion of treatment) | |
Secondary | Center for Epidemiological Studies Depression Scale for Children (CES-DC) | 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. | Baseline (pre-treatment) | |
Secondary | Center for Epidemiological Studies Depression Scale for Children (CES-DC) | 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. | Approximately 12 weeks (immediately after treatment has been completed) | |
Secondary | Center for Epidemiological Studies Depression Scale for Children (CES-DC) | 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. | Approximately 24 weeks (3 months following completion of treatment) | |
Secondary | Screen for Child Anxiety Related Emotional Disorders (SCARED) | 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. | Baseline (pre-treatment) | |
Secondary | Screen for Child Anxiety Related Emotional Disorders (SCARED) | 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. | Approximately 12 weeks (immediately after treatment has been completed) | |
Secondary | Screen for Child Anxiety Related Emotional Disorders (SCARED) | 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. | Approximately 24 weeks (3 months following completion of treatment) | |
Secondary | Externalising behaviour problems score | 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. | Baseline (pre-treatment) | |
Secondary | Externalising behaviour problems score | 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. | Approximately 12 weeks (immediately after treatment has been completed) | |
Secondary | Externalising behaviour problems score | 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. | Approximately 24 weeks (3 months following completion of treatment) | |
Secondary | WHO-5 Well-Being Index (WHO-5) | 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. | Baseline (pre-treatment) | |
Secondary | WHO-5 Well-Being Index (WHO-5) | 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. | Approximately 12 weeks (immediately after treatment has been completed) | |
Secondary | WHO-5 Well-Being Index (WHO-5) | 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. | Approximately 24 weeks (3 months following completion of treatment) | |
Secondary | Youth Life Orientation Test (YLOT) | 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. |
Baseline (pre-treatment) | |
Secondary | Youth Life Orientation Test (YLOT) | 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. |
Approximately 12 weeks (immediately after treatment has been completed) | |
Secondary | Youth Life Orientation Test (YLOT) | 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. |
Approximately 24 weeks (3 months following completion of treatment) | |
Secondary | PSYCHLOPS Pre-Therapy (Kids or Teen) | 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. | At first treatment session, approximately 1-2 weeks after baseline | |
Secondary | PSYCHLOPS During Therapy (Kids or Teen) | 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. | At mid-point treatment session, approximately 5-6 weeks after baseline | |
Secondary | PSYCHLOPS Post-Therapy (Kids or Teen) | 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. | At final treatment session, approximately 8-12 weeks after baseline | |
Secondary | Client Monitoring Form (CMF) | Client Monitoring Form developed for this study to measure mental health problems, substance use, and safety issues during treatment, Arabic version, child self-report. | Baseline (pre-treatment) | |
Secondary | Client Monitoring Form (CMF) | Client Monitoring Form developed for this study to measure mental health problems, substance use, and safety issues during treatment, Arabic version, child self-report. | Final treatment session, approximately 8-12 weeks after baseline |
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