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

NCT05270226 | Completed

• 1 other identifier: Work-MATE
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ADHD

Keywords

Work Performance; Occupational Performance; Executive Functions; Quality of Life; Organization in Time

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• 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 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 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)

Study Arms (2)

Group A

EXPERIMENTAL

After being randomly allocated, group A participants had first evaluation (out of 3, pre-intervention) and immidiatlly recived Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE).

Behavioral: The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE)

Group B

EXPERIMENTAL

After being randomly allocated, group B participants had first evaluation (out of 4), then waiting-phase of 10-11 weeks, and after second evaluation (pre-intervention) start Work-MATE intervention process.

Behavioral: The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE)

Interventions

The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE) BEHAVIORAL

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).

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sara Rosenblum: lead

Study Sites (1)

University of Haifa

Haifa, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Sara Rosenblum, Prof.

  University of Haifa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in the Department of Occupational Therapy, Faculty of Social Welfare

Model Details: The study was designed as a randomized controlled and crossover trial to evaluate the evaluate the effect of the Work-MATE program on occupational performance at work of adults with ADHD. The first Intervention Group (A) received the Work-MATE intervention. After a crossover switching trial, the second Intervention Group (B) received the Work-MATE intervention in order. All evaluations were online, in similar environmental conditions. The Ethics Committee of the University of Haifa approved the study.

Study Record Dates

• First Submitted: February 12, 2022
• First Posted: March 8, 2022
• Study Start: June 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: February 21, 2020
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

IL (1)