Randomized Controlled Trial of PR-ESSENCE - an Intervention Model for Young People With Explosive and Challenging Behavior
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 主要终点
- CGI-S/CGI-I change
研究概览
简要总结
The method "Collaborative and Proactive Solutions" (CPS) was developed by Dr. Ross Greene, Harvard University, to understand and help kids with social, emotional, and behavioral challenges. The underlying theory is that challenging behavior is caused by lagging cognitive skills, commonly in the domains of flexibility/adaptability, frustration tolerance, and problem-solving. Thus, challenging behavior can be seen as a form of developmental delay, and the most effective way for adults to help the children and to facilitate interaction with them is to understand the lagging skills behind the behavior and to change their own mindset accordingly.
ADHD and autism belong in a group of overlapping neurodevelopmental conditions now often referred to under the umbrella term of ESSENCE (Early Symptomatic Syndromes Eliciting Neurodevelopmental Clinical Examinations). A common impairing problem in both autism and ADHD - and in several of the other disorders in the group of ESSENCE (including Tourette syndrome and other tic disorders) - is the marked inability to control temper, coupled with oppositional-defiant behaviors.
The CPS-method has been evaluated by Ross Greene et al. in United States studies for families, in schools, and in institutions for young people with serious behavior problems. Our research group published the first Swedish study with the method in 2012, a small open pilot study. Based on experiences in clinical work after that study our group reached the conclusion that, in order for the intervention to be useful for families with severely impairing ESSENCE, the CPS model needed to be modified. After a number of research meetings and seminars, we therefore designed a new model, based on our CPS-experience, that we now refer to as PR-ESSENCE (Problem Resolution in ESSENCE).
The present study is a randomized controlled trial for approximately 130 children and adolescents aged 5-18 years, with neuropsychiatric disorders (for instance Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Autism Spectrum Disorder (ASD), Tourette syndrome, learning difficulties), children who have been assessed at our Child Neuropsychiatry Clinic (CNC), and from the Habilitation Services, Child Psychiatry Units or schools in the Göteborg region.
详细描述
The "Collaborative Problem Solving" model was developed by Greene for the treatment of youth with oppositional behavior, and is now called Collaborative & Proactive Solutions (CPS). The aim of CPS is to help caregivers and children practice and learn problem solving strategies in collaboration. The theoretical base of the model is that problematic behavior is mainly caused by lagging skills, especially regarding frustration tolerance, flexibility and problem solving ability. The CPS model engages both the child and the parents in training, and may therefore have potential to give long-term improvement of lagging skills in handling problematic situations and to change the mindset towards strategies of mutual problem solving.
The CPS model was evaluated in a United States trial comparing CPS to Barkley's Parent Management Training program (PMT) in 47 children aged 4-12 years with ODD and affective dysregulation. Outcomes were similar between the two methods in most measures post-treatment and at 4 months follow-up. A recent larger randomized controlled US trial enrolled 134 children with ODD, aged 7 - 14 years, who were randomized to three groups (CPS, PMT or Waitlist Control). Both treatment groups had equivalent results in treatment response and remission of diagnostic status (50% were much to very much improved and no longer met diagnostic criteria), and both were superior to the WLC condition.
The first Swedish study of CPS, published by our research team 2012, was a small open pilot trial of 3 months CPS for 17 families and children aged 7-13 years, with ADHD, ODD and explosive behavior, showed promising results. At post-treatment 53% of the children were much or very much improved on global symptom and function ratings (Clinical Global Impression-Improvement; CGI-I rating 1-2), and after another 6 months when the children with severe residual ADHD symptoms also had received stimulant medication, 81% reached CGI-I levels of 1-2.
Thus previous research has suggested that CPS is an effective treatment for ODD in youth, but effectiveness in samples of children with various neurodevelopmental disorders has not yet been documented. Oppositional and explosive behavior is a major problem among youth with neurodevelopmental disorders and the demand for treatment strategies is great.
Experiences from treatment of children with complex neurodevelopmental disorders - ESSENCE (mainly including autism) have led the therapists in our team to make ESSENCE-adapted modifications to the CPS model, particularly regarding communication, structure, predictability, and focusing on the child's interests to facilitate interaction. We therefore designed a new model, based on our CPS-experience, that we now refer to as PR-ESSENCE (Problem Resolution in ESSENCE). During the early phases of this study, Dr. Greene gave advice and supervision to our treatment team, and the whole PR-ESSENCE model would not have been developed without this input.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded assessors
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents aged 5 to18 years with neuropsychiatric diagnoses and serious challenging behaviors/explosive reactions.
- •Intellectual function in the normal range, according to WISC-test, adaptive function and clinical judgment.
- •Participants treated with psychoactive medication (e.g. for ADHD) can be included if the medication has been unchanged during at least one month prior to baseline, and is unchanged during the treatment period.
排除标准
- •Bipolar disorder, psychosis, or other unstable psychiatric or medical condition that according to the investigators opinion makes study participation unsuitable.
- •Substance Use.
研究组 & 干预措施
PR-ESSENCE treatment
The treatment group receives PR-ESSENCE for 10 weeks. Outcome measures are collected pre- and post-treatment, and after 6 months and one year.
干预措施: PR-ESSENCE treatment (Behavioral)
Control (TAU)
The control group receives 10 weeks of "treatment as usual (TAU)" (that is the standard psychoeducation, support and treatment given to all youth after neuropsychiatric assessment at our clinic), followed by 10 weeks of PR-ESSENCE. Outcome measures were collected pre- and post-treatment, and after 6 months and one year.
干预措施: Control (TAU) (Behavioral)
结局指标
主要结局
CGI-S/CGI-I change
时间窗: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
Clinical Global Impression - Severity and Improvement (by blinded assessor). Range 1-7 points, lower is better. A global assessment of severity and change in behavior problems and everyday function.
次要结局
- Beck's Youth Inventory change(Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment)
- FBIM change(Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment)
- Problem solving scale change(Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment)
- SNAP-IV change(Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment)
- ECBI change(Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment)
- RPQ change(Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment)
- ODD Scale change(Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment)
研究者
Mats Johnson
MD PhD
Göteborg University