Clinical trial NCT05270226: Metacognitive ADHD Telehealth Intervention for Work-performance Enhancement (Work-MATE)
Official title: Developing and Evaluating a Metacognitive ADHD Telehealth Intervention for Work-performance Enhancement (Work-MATE) Amongst Adults With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: Work Performance
Occupational Performance
Executive Functions
Quality of Life
Organization in Time
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Canadian Occupational Performance Measure (COPM) at 3 and 6 months
timeFrame: Measure 1 (baseline; at third intervention meeting), measure 2 (after intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)
measure: Change from Baseline Behavior Rating Inventory of Executive Function-Adult version (BRIEF-A) at 3 and 6 months
timeFrame: 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:
measure: Change from Baseline Adult ADHD Quality of Life Questionnaire (AAQoL) at 3 and 6 months
timeFrame: 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)
measure: Change from Baseline Time Organization and Participation Scale (TOPS) at 3 and 6 months
timeFrame: 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)
measure: Change from Baseline Brown Attention-Deficit Disorder Scales (BADDS) at 3 and 6 months
timeFrame: 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)
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: University of Haifa
Study officials:
affiliation: University of Haifa
name: Sara Rosenblum, Prof.
role: STUDY_DIRECTOR
References: