Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention (t-CETA) for Syrian Refugee Children in Lebanon: Phase II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Emotional and behavioural problem composite score
研究概览
简要总结
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.
详细描述
Common Elements Treatment Approach (CETA) is a transdiagnostic treatment approach designed to treat common mental health problems such as anxiety, depression, post-traumatic stress disorder (PTSD), and externalising behaviour problems. It uses a Cognitive Behavioural Therapy (CBT) approach and has been used in both adults and children. There are a number of different components that can be put together to provide a treatment approach that is tailored to each individual. For this study CETA has been adapted to be delivered over the telephone (t-CETA).
The overall study has two specific objectives:
- Development of telephone-delivered CETA (t-CETA) by adapting the scientifically validated face-to face CETA programme (including manual and detailed training material). This was completed during Phase I.
- Scientific evaluation of the effectiveness of t-CETA applying a randomized controlled clinical trial. This will be completed during Phase II and is described in the remainder of this submission.
Study design:
The implementation and efficacy of t-CETA will be tested with a randomized controlled clinical trial. Up to 120 Syrian refugee children will be randomly allocated to either t-CETA or treatment as usual provided by Médecins du Monde in primary healthcare centres in the Beqaa valley. Clinical interviews with children and primary caregivers will be conducted before the intervention to determine suitability for inclusion. Assessments will be carried out before and after the intervention as well as during a 3-month follow-up assessment by independent trained enumerators blind to study condition. If families do not agree to randomisation, they will be offered t-CETA only and their data will be used to carry out additional evaluation of efficacy, implementation and acceptability of the intervention. Implementation and acceptance of the intervention will be further assessed with a qualitative study based on interviews with a subset of involved Syrian refugee children, their caregivers as well as mental health staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants will not be blind to treatment allocation. The team providing treatment and conducting in-session assessments will not be blind to treatment allocation.
One individual will be responsible for processing raw data and hence will not be blind as to treatment allocation.
The team carrying out independent assessments will be blind to treatment allocation.
The investigator team carrying out data analysis will be blind to treatment allocation.
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8-17 years, male or female
- •Live with a parent or other legal guardian
- •Child and/or parent identifies that the child has mental health difficulties and requests services
- •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]
- •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
- •Parent/legal guardian gives informed consent and child gives assent to take part
排除标准
- •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)
- •Parent or legal guardian is not able to provide consent
- •Child protection issues (e.g., acute maltreatment) that are judged by clinician to make trial inclusion inappropriate
- •Any inclusion criteria not met
结局指标
主要结局
Emotional and behavioural problem composite score
时间窗: Approximately 24 weeks (3 months following completion of treatment)
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.
World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): caregiver report
时间窗: Approximately 24 weeks (3 months following completion of treatment)
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.
World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): child report
时间窗: Approximately 24 weeks (3 months following completion of treatment)
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.
次要结局
- Child PTSD Symptom Scale (CPSS)(Approximately 24 weeks (3 months following completion of treatment))
- Youth Life Orientation Test (YLOT)(Approximately 24 weeks (3 months following completion of treatment))
- PSYCHLOPS During Therapy (Kids or Teen)(At mid-point treatment session, approximately 5-6 weeks after baseline)
- Center for Epidemiological Studies Depression Scale for Children (CES-DC)(Approximately 24 weeks (3 months following completion of treatment))
- Externalising behaviour problems score(Approximately 24 weeks (3 months following completion of treatment))
- PSYCHLOPS Pre-Therapy (Kids or Teen)(At first treatment session, approximately 1-2 weeks after baseline)
- Screen for Child Anxiety Related Emotional Disorders (SCARED)(Approximately 24 weeks (3 months following completion of treatment))
- WHO-5 Well-Being Index (WHO-5)(Approximately 24 weeks (3 months following completion of treatment))
- PSYCHLOPS Post-Therapy (Kids or Teen)(At final treatment session, approximately 8-12 weeks after baseline)
- Client Monitoring Form (CMF)(Final treatment session, approximately 8-12 weeks after baseline)
研究者
Michael Pluess
Professor of Developmental Psychology, Head of Psychology Department
Queen Mary University of London