The Bio-psycho-social Effects of a Novel Form of Psychotherapy for Preschool Children Suffering From Anxiety Disorders: a Comparison of Short-term Play Therapy, Dyadic Therapy and Controls
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Symptom change as measured by the CBCL
研究概览
简要总结
The study will comprise of three groups of children (n=40): 1. A group receiving a novel short-term dynamic play therapy. 2. Dyadic therapy 3. Control group who will not receive therapy. All children will be assessed for psychopathology (anxiety, depression and behavioral problems) using standardized instruments such as semi-structured interview and self-reported questionnaires; EEG recordings will be performed from child and parents in order to asses brain synchrony; Cortisol (CT), Dehydroepiandrosterone (DHEA), Oxytocin (OT) and Secretory Immunoglobulin A (SIgA) will be assessed by using saliva sampling; and father-mother-child interactions will be videotaped and analyzed. Narrative descriptions will be obtained from parents, and the interviews recorded for voice analysis. Assessment will be made at baseline and then bi-monthly for six months.
详细描述
Anxiety disorders are the most common disorders across the lifespan and tend to have both an early onset and persistent course throughout life. Since the preschool years mark a sensitive period for the development and exacerbation of anxiety symptoms in children, which often persist throughout childhood and adolescence, there is an urgent need to understand this condition in the most detailed manner and find efficient therapeutic solutions. In this Randomized control study (RCT), the investigators will test the efficacy of two interventions for childhood anxiety disorders: a special emotion-focused therapy and a dyadic parent-child intervention.
DESGIN Recruitment: consecutive admissions to the preschool clinic at the Intradisciplinary Center at Herzliya will be asked to participate in the study.
Baseline Diagnosis:
- Psychiatric diagnosis: will be made by using a combination and integration of the childhood version of the Schedule for Schizophrenia and Affective Disorders (K-SADS-PL) and the Preschool Age Psychiatric Assessment (PAPA). Diagnosis will be made according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) and Diagnostic Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood (DC 0-5). These semi-structured interviews will be conducted by a clinical psychologist with a special expertise in evaluation and treatment in preschool children (YAL). All diagnoses will then be checked with a senior child and adolescent psychiatrist.
- Behavioral profiles: The Child Behavioral Checklist for preschoolers will be administered to parents and will generate behavioral profiles adjusted for gender.
Randomization:
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
- Single (Outcomes Assessor)
盲法说明
outcome assessors: Post graduate students in clinical psychology, lab technicians
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All consecutive admission to the early childhood clinic at the IDC Herzliya
排除标准
- •Parents and children not living in the same household
结局指标
主要结局
Symptom change as measured by the CBCL
时间窗: Every two months for a period of six months
The CBCL measures symptoms of psychopathology in a quantitive manner. Reduction in the number symptoms means a favorable outcome.
Maternal Sensitivity as measured with the CIB (coding interactional behavior)
时间窗: Every two months for a period of six months
This measure is a video of mother-child interactions, a higher score is a more favorable outcome. scores range from a minimum of 0 to a maximum of 5.
次要结局
未报告次要终点
研究者
Yael Apter
Research psychologist
Interdisciplinary Center Herzliya