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临床试验/NCT05270226
NCT05270226已完成不适用

Developing and Evaluating a Metacognitive ADHD Telehealth Intervention for Work-performance Enhancement (Work-MATE) Amongst Adults With ADHD

Sara Rosenblum1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Change from Baseline Behavior Rating Inventory of Executive Function-Adult version (BRIEF-A) at 3 and 6 months

研究概览

简要总结

Adults with Attention-deficit hyperactivity disorder (ADHD) experience poor occupational performance at work compare to adults without ADHD, manifested at tendencies toward unemployment, job instability, work accidents, and sickness absences. This poor occupational performance at work may be partly caused by difficulties at executive functions (EF) abilities, and at the ability to set and attain goal directed work-activities at a satisfactory manner. Therefore, improvement at those abilities may followed by occupational performance at work enhancement of adults with ADHD. Such improvement may enhance adults with ADHD quality of life.

Despite the wide-ranging implications of poor occupational performance at work of adults with ADHD, treatments which focus at this component improvement among adults with ADHD are lack.

The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE) is an innovative program that aim to improve occupational performance at work of adults with ADHD, by enhancing their EF abilities, self-awareness, and personal strategy use.

This program was established based on existing fundamental models and approach, (1) The World Health Organization's international classification of functioning, disability and health (ICF) (WHO, 2001), (2) Person-Environment-Occupation-Performance model (Baum, Christiansen, & Bass-Haugen, 2015) (3) The Dynamic Interactional Model of cognition (DIM; Toglia, 2018) and the Multicontex approach (Toglia, 2018) which based on the it, and (4) Telehealth as service-delivering model.

The Work-MATE aim to promote self-awareness and self-generation of personal strategies and increase efficiency strategy use across meaningful purposeful everyday work activities (i.e., goal directed work-activities). It is a short, synchronous and hybrid teleintervention program of eleven 1-hour weekly individual sessions, focused directly on occupational performance at work enhancement of adults with ADHD.

详细描述

Research Aim:

To develop and evaluate effectiveness of Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE), of adults with ADHD.

Hypotheses:

The study sample (n=46) includes adults with ADHD, after confirmation of inclusion and exclusion criteria and symptoms consistency of ADHD. Participants enrolled randomly into two groups:

  1. Group A (n=31)- received treatment immediately after the first assessment.
  2. Group B (n =16)- was reassessed 10-11 weeks after the first assessment (the length of the treatment process), and then received treatment.

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
Double (Participant, Care Provider)

盲法说明

Participants were randomly assigned to Intervention Group A or B. Randomization sequence was created using permuted block design manually, with a 1:2 allocation, using block size of 6. The result of the randomization was blinded for participants and occupational therapists (OTs) who preformatted the intervention processes.

Participants had not contact with other participants during all study phases. To address potential bias, all study assessments completed online, without involvement of the OTs who preformatted the intervention processes. The OTs and the participants were not exposed to baseline assessment scores or post-intervention scores of any study measure.

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants worked at least 3 months at the same workplace.
  • Participants had formal medical diagnosis of ADHD.
  • Symptoms consistent with ADHD were confirmed either by the Adult ADHD Self-Report Scale (ASRS) version 1.1 (Kessler et al., 2005) final score or by medium-to-high probability of ADHD according to the BADDS (Brown, 2012).
  • Participants had at least one EF deficit according to the BRIEF-A (Roth et al., 2005).
  • Participants not receiving any functional additional treatment during the study period.
  • Participants read and write Hebrew fluently.

排除标准

  • People who self-reported comorbid mental health disorders, motor or neurological disabilities, chronic diseases, or significant injuries.

结局指标

主要结局

Change from Baseline Behavior Rating Inventory of Executive Function-Adult version (BRIEF-A) at 3 and 6 months

时间窗: Measure 1 (baseline; 1 week before the beginning of the intervention), measure 2 (after the intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)

BRIEF-A measure EF abilities following the intervention. The score includes a global executive composite (GEC) index that represents the overall EF score, composed of a behavioral regulation index (BRI) score and a metacognition index (MI) score with nine nonoverlapping score scales. Scores of 65 or more for each index or scale indicate a clinical deficit.

Change from Baseline Canadian Occupational Performance Measure (COPM) at 3 and 6 months

时间窗: Measure 1 (baseline; at third intervention meeting), measure 2 (after intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)

COPM used to evaluate self-perception of occupational performance at work. During semi-structured interview at the third session of intervention, the participant was asked to identify two meaningful activities for which he perceived the greatest performance problems during work, or activities that influence his occupational performance at work. Those two activities were set up as the two intervention goals. Participants rated each activity for performance from 1 (not able to do at all) to 10 (able to do extremely well) and similarly for satisfaction with performance. Significant improvement was considered as a change of at least two points between measures.

次要结局

  • Change from Baseline Time Organization and Participation Scale (TOPS) at 3 and 6 months(Measure 1 (baseline; 1 week before the beginning of the intervention), measure 2 (after the intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline))
  • Change from Baseline Adult ADHD Quality of Life Questionnaire (AAQoL) at 3 and 6 months(Measure 1 (baseline; 1 week before the beginning of the intervention), measure 2 (after the intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline))
  • Change from Baseline Brown Attention-Deficit Disorder Scales (BADDS) at 3 and 6 months(Measure 1 (baseline; 1 week before the beginning of the intervention), measure 2 (after the intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline))

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sara Rosenblum

Professor in the Department of Occupational Therapy, Faculty of Social Welfare

University of Haifa

研究点 (1)

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