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A randomized controlled trial of a new intervention in early symptomatic syndromes eliciting neurodevelopmental clinical examinations: PR-ESSENCE
European Child & Adolescent Psychiatry ( IF 6.0 ) Pub Date : 2021-07-03 , DOI: 10.1007/s00787-021-01837-z
Mats Johnson 1 , Carina Gillberg 1 , Ingrid Vinsa 1 , Gunnar Fransson 1 , Lena Samuelsson 1 , Klara Jakobsson 1 , Sven Östlund 1 , Elisabeth Fernell 1 , Christopher Gillberg 1
Affiliation  

The need for effective intervention programs for youth with neurodevelopmental problems (ESSENCE) and challenging behaviour is great. This study examines Problem Resolution in ESSENCE (PR-ESSENCE), a newly developed model in which children and parents develop mutual problem resolution strategies. Ten-week randomized controlled trial of PR-ESSENCE for children and adolescents aged 5–18 years, compared to treatment as usual. Outcomes were assessed at baseline and randomized period endpoint. Primary outcome was the Clinical Global Impression—Improvement scale (CGI-I) rated by blinded assessors. Secondary outcomes were rated by parents—SNAP-IV, Eyberg Child Behavior Inventory (ECBI), Relationship Problems Questionnaire, Family Burden of Illness Module, and children—Beck Youth Inventories (BYI). ClinicalTrials.gov identifier: NCT03780413. The study enrolled 108 participants (active n = 72; controls n = 36, randomized 2:1), of whom 95 completed the randomized period. No clinically significant group differences were found in baseline characteristics. More than half had autism and 80% had ADD or ADHD. Large treatment effects were seen on CGI-I (ITT analysis, Effect Size 1.48). Treatment responders, much/very much improved on CGI-I, were 51.4% in active group and 5.6% of controls. Effect sizes were medium to large in parent ratings on SNAP-IV (ODD and ADHD symptoms), ECBI (behaviour problems), and in BYI child self-ratings of disruptive behaviour. PR-ESSENCE treatment improved global symptoms and functioning (CGI-I), behaviour problems, ADHD and ODD symptoms, and disruptive behaviour. Treatment effects were at least equivalent to those in previous studies of well-established Parent Management Training and Collaborative Problem Solving programs.



中文翻译:

一项针对引发神经发育临床检查的早期症状综合征的新干预措施的随机对照试验:PR-ESSENCE

非常需要针对有神经发育问题 (ESSENCE) 和具有挑战性行为的青少年制定有效的干预计划。本研究考察了 ESSENCE (PR-ESSENCE) 中的问题解决,这是一种新开发的模型,在该模型中,儿童和父母制定相互解决问题的策略。与常规治疗相比,针对 5-18 岁儿童和青少年的 PR-ESSENCE 为期十周的随机对照试验。在基线和随机期终点评估结果。主要结果是由盲法评估员评定的临床总体印象改进量表 (CGI-I)。次要结果由父母——SNAP-IV、Eyberg 儿童行为量表 (ECBI)、关系问题问卷、家庭疾病负担模块和儿童——贝克青少年量表 (BYI) 进行评级。ClinicalTrials.gov 标识符:NCT03780413。n  = 72; 控制n = 36,随机化 2:1),其中 95 人完成了随机化阶段。在基线特征中未发现有临床意义的组间差异。超过一半的人患有自闭症,80% 的人患有 ADD 或 ADHD。在 CGI-I 上观察到大的治疗效果(ITT 分析,效果大小 1.48)。治疗反应者,在 CGI-I 上有很大/非常大的改善,在活性组中为 51.4%,在对照组中为 5.6%。父母对 SNAP-IV(ODD 和 ADHD 症状)、ECBI(行为问题)和 BYI 儿童破坏性行为自我评级的影响大小为中到大。PR-ESSENCE 治疗改善了整体症状和功能 (CGI-I)、行为问题、ADHD 和 ODD 症状以及破坏性行为。治疗效果至少等同于先前对行之有效的家长管理培训和协作解决问题计划的研究。

更新日期:2021-07-04
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