Emotion Detectives - Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children: A Randomized Controlled Trial in the Portuguese Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Changes of children's anxiety and depression
研究概览
简要总结
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) is a transdiagnostic and emotion-focused cognitive-behavioral group intervention for children aged 6-12 years old with emotion disorders (i.e., anxious and/or mood disorders) and their parents.
UP-C consists of 15 weekly group sessions and unifies cognitive-behavioral, contextual (e.g., mindfulness) and parental training techniques, for parents and children, aimed at reducing the intensity and frequency of strong and aversive emotional experiences in children and their clinical symptomatology.
The present study aims to assess the feasibility, acceptability and efficacy of the UP-C in the Portuguese population in reducing children's anxiety/depression symptoms. It also aims to investigate which mechanisms explain the therapeutic change.
Participants will be recruited at child mental health services and schools from Central Portugal and also through online dissemination of the study.
A randomized controlled trial (RCT) will be conducted in a sample of children aged 6-13 years old with emotional disorders and their parents in order to answer the critical question of whether the UP-C is more efficacious in reducing children's symptomatology than a psychoeducational group intervention (active control group).
Once the eligibility criteria are met (assessed by the project researchers) parents and children will be randomly assigned to one of two study conditions:
- experimental group (i.e., children and parents who benefit from the UP-C program).
- control group (i.e., children who benefit from a psychoeducational intervention program, named "ABC of Emotions").
Parents and children from both groups will complete several psychometrically robust and developmentally appropriate measures at baseline (T0), mid-treatment (only at week 7 of the UP-C; T1), post treatment (T2) and at 3 months follow-up (T3).
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 (Investigator)
盲法说明
Single-blind - the investigator is unaware of the intervention assignment
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-13
- •Primary diagnosis of an anxiety and/or depression disorder
- •Speaking, reading and understanding Portuguese
排除标准
- •Diagnosis of a psychotic disorder, bipolar disorder or intellectual disability;
- •Severe current suicidal/homicidal ideation;
- •The child is not on a stable dose of a psychotropic or other type of medication for at least 1 month prior to T0 assessment.
结局指标
主要结局
Changes of children's anxiety and depression
时间窗: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Changes of children's severity of psychopathology and improvement
时间窗: Baseline, Póst treatment (15 weeks)
Measured with an adaptation of Clinical Global Impression (CGI). The CGI is composed by a severity of illness scale and a scale evaluating changes from the initiation of treatment. Higher scores are indicative of higher severity of psychopathology and lower improvement from the initiation of treatment.
次要结局
- Changes of child anxiety life interference(Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months)
- Changes of children's behavioral avoidance(Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months)
- Changes of children's negative emotionality(Baseline, Póst-treatment (15 weeks))
- Changes of children's anxiety sensitivity(Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months)
- Changes of children's mindfulness skills(Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months)
- Changes of children's psychological flexibility(Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months)
- Changes of children's tolerance of negative emotions(Baseline, Mid-treatment (7 weeks), Póst treatment (15 weeks), Follow-up 3 months)
- Changes of children's emotional expression and emotion awareness(Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months)
- Changes of parent's anxiety and depression(Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks))
- Changes of parental anxiety, parental overprotection and parental support of children's coping behaviors(Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months)
- Changes of parental neuroticism(Baseline, Póst-treatment (15 weeks))
- Changes of parental criticism(Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months)
- Changes of children's negative affect(Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months)
- Changes of children's negative cognitive error(Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months)
- Changes of shaping of negative emotions(Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months)
- Changes of mindfulness in parenting(Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months)
- Changes of parental inconsistency and permissiveness(Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months)
研究者
Brigida Caiado
Dra. , PhD student
University of Coimbra