Metacognitive ADHD Telehealth Intervention for Work-performance Enhancement (Work-MATE)

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05270226
• Other study ID #: Work-MATE
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: February 21, 2020

Study information

• Verified date: February 2022
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Both groups were reassessed at the end of the treatment (second assessment for group A and third assessment for group B). An additional assessment was performed three months after the end of treatment.

The hypotheses are presented in three stages:

Stage 1:

1. A comparison of the characteristics of study groups (A and B) participants as a preliminary stage to their unification as one group (n=46).

Hypothesis 1: Differences will not be found in the demographic and occupational characteristics of participants when assessed using demographic and occupational questionnaires, and the ADHD characteristics using the Brown Attention-Deficit Disorder Scales (BADDS).

2. To examine the change in group B (n = 16) prior to treatment.

Hypothesis 2: Differences will not be found between assessment 1 and assessment 2 before the treatment in the following variables:

2. a. EF abilities- measured by Behavior Rating Inventory of Executive Function-Adult version (BRIEF-A) 2. b. occupational performance at work- evaluated by performance and satisfaction with performance scores as measured with the Canadian Occupational Performance Measure (COPM).

2. c. Quality of life- evaluated by Adult ADHD Quality of Life Questionnaire (AAQoL).

2. d. Organization in time ability- evaluated by Time Organization and Participation Scale (TOPS).

2. e. ADHD characteristics- evaluated by BADDS questionnaire.

Stage 2: Effectiveness of the Treatment

1. Examination of the effectiveness of the treatment process within both study groups (A and B) (n = 46), before and after treatment, and three months after its completion.

Hypothesis 3: Differences will be found in both study groups (research and comparison) before and after treatment, and after a follow-up assessment three months later, regarding:

3. a. EF abilities- measured by BRIEF-A. 3. b. occupational performance at work- evaluated by performance and satisfaction with performance scores as measured with the COPM.

3. c. Quality of life- evaluated by AAQoL. 3. d. Organization in time ability- evaluated by TOPS. 3. e. ADHD characteristics- evaluated by BADDS questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 21, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Participants worked at least 3 months at the same workplace.

2. Participants had formal medical diagnosis of ADHD.

3. 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).

4. Participants had at least one EF deficit according to the BRIEF-A (Roth et al., 2005).

5. Participants not receiving any functional additional treatment during the study period.

6. Participants read and write Hebrew fluently.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE)
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. The Work-MATE is a short, synchronous and hybrid teleintervention program of eleven 1-hour weekly individual sessions. It offers a written standardized protocol, which include uniform structure of each intervention session and pool of therapy aids (for self-tailored matching by occupational therapists).

Locations

Country	Name	City	State
Israel	University of Haifa	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Sara Rosenblum

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Canadian Occupational Performance Measure (COPM) at 3 and 6 months	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.	Measure 1 (baseline; at third intervention meeting), measure 2 (after intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)
Primary	Change from Baseline Behavior Rating Inventory of Executive Function-Adult version (BRIEF-A) at 3 and 6 months	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.	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)
Secondary	Change from Baseline Adult ADHD Quality of Life Questionnaire (AAQoL) at 3 and 6 months	AAQOL measures QoL of adults with ADHD, focusing on four domains: life productivity, psychological health, relationships, and life outlook. The AAQoL consists of 29 items rated on a 5-point scale for frequency of occurrence, which yields a total score and four subscale scores (reflecting the four domains). higher scores indicating better QoL.	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)
Secondary	Change from Baseline Time Organization and Participation Scale (TOPS) at 3 and 6 months	TOPS assesses the perceived ability of the individual to organize daily life tasks on time. Using this questionnaire three domains of organization on time had been evaluated: A, daily task performance at an appropriate pace; B, the individual's success in organizing a whole day or a certain period in a satisfactory manner; C, the frequency of emotional responses following disorganization in time. Because domain D items are used for clinical purposes, they not statistically analyzed in this study. In all domains, lower scores indicate higher risk of difficulties in organization and participation in time in daily tasks. Participants who had a mean final score less than 3.16 were considered to be at risk for difficulties in on-time organization of daily life tasks.	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)
Secondary	Change from Baseline Brown Attention-Deficit Disorder Scales (BADDS) at 3 and 6 months	BADDS measures a range of ADHD symptoms. The items are grouped into five clusters: organizing and activating to work, ssustaining attention and concentration, sustaining energy and effort, Managing Affective Interference, and utilizing working memory and accessing Recall. Clusters T scores greater than 65 is considered clinically significant	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)