Long-term Outcome of a Transdiagnostic Cognitive-behavioral Psychotherapy Compared With Management as Usual for Youth With Common Mental Health Problems: a 3-year Follow-up of a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- The child's impact of mental health problems reported by the parent on the Strengths and Difficulties Questionnaire Impact Scale.
研究概览
简要总结
This is a three-year follow up of a previously completed randomized clinical trial (RCT) of a transdiagnostic cognitive and behavioral (CBT) program ("Mind My Mind" [MMM]) compared to management as usual (MAU) in youth with emotional and behavioral problems.
The effectiveness trial (Clinical Trials Identifier: NCT03535805) evaluated an intervention for help-seeking youth with emotional and behavioral health problems below the threshold for referral to specialized treatment. The experimental intervention MMM consisted of 9-13 weekly, individual therapy sessions delivered by psychologists in a non-specialist school-based setting. The CBT-methods were organized in modules for anxiety, depression and/or behavioral problems, and the therapy was completed within 17 weeks. The MAU was enhanced by two care-coordination visits to help coordinate the usual care in the four municipalities in Denmark. The trial was conducted in four diverse municipalities in Denmark.
The aim of this study is to determine the long-term effects of the transdiagnostic, modular CBT program ("Mind My Mind" [MMM]) compared to management as usual (MAU).
The three-year follow-up of the RCT of MMM versus MAU is nested in a larger study of help-seeking youth screened for eligibility and stratified into three groups with increasing severity of problems. Youths with an intermediate level of problems were included in the RCT. We screened 573 help-seeking youths, and we included and randomized a total of 396 youths (age 6-16 years, with anxiety, depressive symptoms, and/or behavioral problems) to MMM (n=197) or MAU (n=199).
The study participants comprise the 396 youths and their parents who participated in the RCT. We will use the help-seeking population and the background population in the four municipalities as reference groups.
The follow-up study does not include an intervention. The long-term outcome of MMM versus MAU will be investigated using parent-reported questionnaires administered in average three years after random allocation to intervention. All study participants are followed in the Danish national registries.
详细描述
Background: Behavioral and cognitive-behavioral therapy (CBT) programs targeting a single class of problems are effective, however, these interventions have not been widely implemented, and the population of youth with common mental health problems is markedly undertreated. This knowledge-practice gap calls for pragmatic trials testing the long-term effectiveness of scalable interventions for common mental health problems among youth.
Objective: This is a three-year follow up of a previously completed, randomized clinical trial (RCT) of a transdiagnostic cognitive and behavioral (CBT) program ("Mind My Mind" [MMM]) compared to management as usual (MAU) in youth with emotional and behavioral problems. The RCT (Clinical Trials Identifier: NCT03535805) evaluated a scalable, transdiagnostic intervention for help-seeking youth with emotional and behavioral health problems below the threshold for referral to specialized mental health services.
The specific aim of this follow-up study is to determine the long-term effects of the transdiagnostic and modular CBT program ("Mind My Mind" [MMM]) compared to management as usual (MAU). The secondary aim is to conduct a cost-effectiveness analysis of MMM versus MAU.
Design: This long-term follow-up of the MMM versus MAU is nested in a larger observational study of the population of help-seeking youths who were screened for eligibility. We used a stage-based approach to identify youths with mental health problems requiring an intervention and to stratify the youths into three groups with increasing severity of problems. The youth with an intermediate level of emotional and behavioral problems were included in the RCT. The long-term outcome of the two comparison groups in the RCT will be investigated by administration of research questionnaires to the parents, and the total study population will be described by use of register-based data. The combined use of questionnaires and register-based data will minimize problems of attrition.
Setting: Non-specialist school-based settings in four municipalities in Denmark.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the Mind My Mind RCT (n=396)
- •Written consent by the parent and legal guardian to take part in the 3-year follow-up of the Mind My Mind RCT by answering the web-based questionnaires
排除标准
- •Withdrawal from the follow-up of Mind My Mind RCT (n=63).
结局指标
主要结局
The child's impact of mental health problems reported by the parent on the Strengths and Difficulties Questionnaire Impact Scale.
时间窗: Last month at 3-year follow-up
The parent-reported Strengths and Difficulties Questionnaire (SDQ) Impact Scale is scored from 0 to 10 (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) with higher scores indicating more impact of mental health problems. The minimum relevant difference in impact of mental health problems measured by the SDQ Impact Scale was set at 1.0 corresponding to a change from severe to moderate, or from moderate to little-or-no impact in one of the five domains of child's life (distress, home-life, friendships, classroom learning and leisure activities). The SDQ Impact was previously measured at week 0, 2, 4, 6, 8, 10, 12, 14, 18 and 26 asking about the last six months at baseline and asking about the last month at each follow-up.
次要结局
- Emotional and behavioral problems(Last month at 3-year follow-up)
- School attendance: proportion of school-days within the last 4 weeks, where the child is present (no illegal absence)(Last four weeks at 3-year follow-up)
- Child Health Utility instrument (CHU9D)(The present day at 3-year follow-up)
- The Parental Stress Scale (PSS)(Present time at 3-year follow-up)
研究者
Pia Jeppesen, MD
Associate clinical professor, PhD,
Mental Health Services in the Capital Region, Denmark