- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06774378
Efficacy of an Occupational Intervention for Improving Quality of Work Life in Adults Living With ADHD
Efficacy of an Occupational Intervention for Quality of Work Life in ADHD: A Randomized Controlled Trial Protocol
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this study, the research team has developed a psychosocial group intervention specifically aimed at improving quality of life at work for ADHD workers. Work-related themes cover motivation, accommodations, problem solving, cognitive functions (i.e. attention and memory), hyperactivity and impulsivity, interpersonal interactions, and medication management.
The general objective of this project is to evaluate the effectiveness of this new psychosocial intervention aimed at improving the quality of life at work of workers living with ADHD, using a randomized controlled trial design.
More specifically, the project will aim to:
Objective #1: Evaluate the effectiveness of the intervention on the quality of life at work of workers living with ADHD (primary outcome).
Objective #2: Evaluate the effectiveness of the intervention on secondary variables, namely the satisfaction of psychological needs, job satisfaction, well-being at work, self-esteem as a worker, occupational self-efficacy, cognitive functioning, self-compassion and the quality of the relationship with members of the workplace (secondary outcomes).
- Hypothesis #1: There will be a statistically significant improvement in the quality of life at work between the pre- and post-intervention measurements in participants receiving the experimental condition.
- Hypothesis #2: There will be a statistically significant condition*time interaction indicating that the improvement in quality of work life among participants receiving the experimental condition between the pre- and post-intervention measurement times will be greater than that of the control condition.
- Hypotheses #3 to 10: There will be a statistically significant improvement in the secondary outcomes mentioned above between the pre- and post-intervention measurements among participants receiving the experimental condition.
- Hypothesis #11: For participants receiving the experimental condition, there will be no statistically significant difference in quality of work life between the follow-up times, indicating that the gains acquired during the intervention will be maintained at 3, 6, 9, and 12 months.
Our research team collaborates with the PANDA Les Deux-Rives association, which is a non-profit organization specializing in ADHD. The psychosocial intervention was co-designed, which allows the involvement of field stakeholders in all stages of the research. This involvement promotes the creation of a final research output that will meet the needs of the target population and that will be easily implemented in the organizational structures already in place.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H2X 3R9
- Université du Québec à Montréal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years
- French language proficiency
- Score ≤ 4 on Part A of the Adult ADHD Self-Report Scale (ASRS-v1.1)
- Currently employed
- Express desire to improve Quality of Work Life (QoWL)
Exclusion Criteria:
- Currently receiving psychosocial services (e.g., psychotherapy, occupational therapy) specifically targeting QoWL improvement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Minds@Work-ADHD-Quality of Life
|
Minds@Work-ADHD-Quality of Life
|
|
Placebo Comparator: Control
Minimal contact comparison approach
|
Weekly 15-minute scripted phone calls made individually by a member of the research team to offer minimal support, without any active intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality of Work Life as Measured by Quality of Work Life Questionnaire (QWLQ) Total Score
Time Frame: Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
The QWLQ will be used to assess multiple dimensions of work-related quality of life, including work tasks, workplace environment and conditions, self-esteem as a worker, sense of belonging to a workgroup, and relationships with coworkers/supervisors.
The questionnaire consists of 40 items rated on a 4-point Likert scale (1 = completely disagree to 5 = completely agree).
Total scores range 40-200, with higher scores indicating greater perceived quality of work life.
|
Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Psychological Need States at Work Scale (PNSW-S) Score
Time Frame: Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
The PNSW-S assesses satisfaction, frustration, and unfulfillment of basic psychological needs (autonomy, competence, relatedness) in the workplace.
The 37-item questionnaire uses a Likert scale, with higher scores (Min = 37, Max = 259) indicating greater psychological need satisfaction.
The scale measures intrinsic motivation based on self-determination theory.
|
Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
|
Change in Minnesota Satisfaction Questionnaire-Short Form (MSQ-SF) Scores
Time Frame: Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
The MSQ-SF is a 20-item measure assessing three domains: Intrinsic Job Satisfaction (task-related attitudes), Extrinsic Job Satisfaction (working conditions/environment), and General Satisfaction.
Items are rated on a Likert scale, with higher scores indicating greater job satisfaction in each domain (Min = 20, Max = 100) .
|
Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
|
Change in Index of Psychological Well-Being at Work (IPWBW) Score
Time Frame: Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
The IPWBW is a 25-item measure assessing five dimensions of well-being at work: Interpersonal Fit, Thriving, Feeling of Competency, Desire for Involvement, and Perceived Recognition at Work.
Items are rated on a Likert scale, with higher scores indicating greater psychological well-being at work (Min = 0, Max = 100) .
|
Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
|
Change in Individual Self-Esteem as a Worker (ISEW) Scale Score
Time Frame: Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
The ISEW is a 10-item scale measuring individual and social dimensions of worker self-esteem.
Items are rated on a Likert scale, with higher scores indicating greater self-esteem as a worker (Min = 10, Max = 40).
|
Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
|
Change in Occupational Self-Efficacy Scale-Short Version (OSES) Score
Time Frame: Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
The OSES is a 6-item measure assessing workers' sense of self-efficacy based on Bandura's self-efficacy theory.
Items are rated on a Likert scale, with higher scores indicating greater occupational self-efficacy (Min = 6, Max = 36).
|
Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
|
Change in Self-Compassion Scale-Short Form (SCS-S) Score
Time Frame: Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
The SCS-S is a 12-item measure assessing self-kindness, self-judgment, and feelings of loneliness.
Items are rated on a Likert scale, with higher scores indicating greater self-compassion in work settings (Min = 12, Max = 60).
|
Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
|
Change in Cognitive Function at Work Questionnaire (CFWQ) Score
Time Frame: Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
The CFWQ is a 29-item measure assessing subjective cognitive difficulties in six domains: Memory, Language, Executive Function, Speed of Processing, Cognitive Control, and Name Memory.
Items are rated on a Likert scale, with higher scores indicating better cognitive functioning at work (Min = 0, Max = 58).
|
Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
|
Change in Team-Member Exchange (TMX) Survey Score
Time Frame: Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
The TMX is a 9-item survey measuring the quality of professional relationships between adults with ADHD and workplace stakeholders.
Items are rated on a Likert scale, with higher scores indicating better quality of work relationships (Min = 9, Max = 63).
|
Assessed at baseline (pre-intervention), immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Professional Situation Assessment: Job Tenure and Strategy Implementation
Time Frame: Assessed at 3, 6, 9, and 12 months after completing the 8-week intervention
|
A follow-up survey assessing two components: (1) job tenure status and (2) implementation of workplace strategies.
Control group participants complete 2 items and intervention group participants complete 3 items to characterize their professional situation.
Responses will track job retention and use of learned strategies in the workplace.
|
Assessed at 3, 6, 9, and 12 months after completing the 8-week intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0SYA-312580
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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