- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04511156
Ensuring Quality in Psychological Support-Foundational Helping Skills (EQUIP-FHS)
September 27, 2022 updated by: Brandon A Kohrt, MD, PhD, George Washington University
A Training Package for the World Health Organization Foundational Helping Skills in Mental Health and Psychosocial Support Services: Study Protocol for A Mixed-Methods Evaluation
There is lack of feasible and effective curricula that can rapidly be taught on basic mental health and psychosocial helping skills.
Through the World Health Organization Ensuring Quality in Psychological Support initiative, a curriculum has been developed focusing on common factors in mental health and psychosocial support, such as verbal and nonverbal communication skills, empathy, rapport building, and promoting hope and expectancy of change.
To minimize training burden and maximize effectiveness, this has been designed as a competency-based training wherein target competencies are evaluated throughout the training so that it can tailored to trainees preexisting skills, rather than using a one-size-fits-all approach to the training.
The training duration and content is modular and flexible, with approximately 16 hours of modules content.
The investigator's goal is to conduct a mixed-methods evaluation of the foundational helping skills program.
In three countries, Nepal, Peru, and Uganda, two trainers (total n=6 across countries) and 36 service providers (total n=108 across countries) without prior training in mental health and psychosocial support skills will receive the training.
Their competency in foundational helping skills will be evaluated prior to training using an objective structured clinical examination approach with standardized role plays using trained raters and actor (i.e., standardized clients).
Role play ratings will be made using the ENhancing Assessment of Common Therapeutic factors.
In addition, trainees knowledge and perceived self-efficacy in foundational helping skills will be evaluated pre- and post-training.
Trainers and trainees will also participate in qualitative interviews regarding feasibility, acceptability, and perceived benefit of the foundational helping skills program.
A mixed methods evaluation of the foundational helping skills curriculum will help to inform further revision of the materials on the Ensuring Quality in Psychological Support platform.
Determination of the change in skills, knowledge, and self-efficacy will identify effective components of the platform and areas for further refinement.
Ultimately, an effective training program in foundational helping skills will contribute to improved health, psychological, and social services around the world.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The World Health Organization Ensuring Quality in Psychological Support program is currently developing a Universal Foundational Helping Skills Training package.
This training package will be freely available for use by all health professionals and other service providers seeking to develop basic skills in mental health and psychosocial support.
These foundational helping skills are based upon common factors in the mental health and psychological services, which have been widely researched and identified as essential and universal prerequisites for the effective delivery of any psychosocial or psychological components in health interventions.
These are also foundational skills are also part of the competencies for non-specialists to deliver psychological interventions in global mental health.
Competent use of these skills by providers improves outcomes for people accessing all fields of health services--ranging from surgery to pain clinics--support greater treatment adherence.
A foundational helping skills training curriculum is needed to promote competency in the provision of warm and trusting relationships between health care providers and people accessing health services.
Other foundational helping skills include rapport building, the demonstration of empathy, using culturally or age-appropriate terminology and concepts for distress, and ensuring communication of hope.
This training guidance will fill the gap many training programs for providers who are not mental health specialists, and the training guidance will be feasible for implementation in low-resource settings.
The training will be aligned with the World Health Organization competency framework for the health sector that is under development, which stipulates foundational helping skills as essential for all health cadres.
The World Health Organization Universal Foundational Helping Skills Training package has the potential to improve competency for basic mental health and psychosocial support services delivered by any health cadres.
This training package, alongside other quality improvement activities, will lead to more effective delivery of quality care for clients and will be one step closer to achieving the global communities' and World Health Organization's goal of universal health care.
The goal of this study is to conduct a mixed-methods evaluation of the Foundational Helping Skills curriculum by observing outcomes for trainees in the program who not have prior mental health and psychosocial support skills training.
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All trainees participating in the training must be over 18 years old,
- have no prior experience in mental health and psychosocial support care or delivery.
- Trainees need to have fluency in the language in which the trainings will be conducted: Nepali in Nepal, Spanish in Peru, and English in Uganda.
- In sites where the training will be delivered remotely, access to online service and device with video and audio capabilities will be expected.
Exclusion Criteria:
- Trainees will not be able to participate in the training if they are under 18 years old,
- have experience in mental health and psychosocial support care of delivery or
- have completed education in a mental health related field or similar training or delivery (e.g., completed psychology degree).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Foundational Helping Skills
The Foundational Helping Skills training will be intervention to be evaluated in this study.
The Foundational Helping Skills is a flexible curriculum, with an approximate 3-day (20 hour) duration to be modified based on context and personnel.
The Foundational Helping Skills is a human-centered design competency-based training in foundational helping skills.
The training curriculum has been developed in a modular format, with each module relating to specific foundational helping skills (e.g., non-verbal communication, confidentiality, etc).
The training curriculum can be found.
The general training outline includes two days of foundational helping skill modules, brief role-play competency assessments at the end of each foundational helping skills training day to inform trainers which competencies need remediation, and a half-day of training that involves a remediation of the specific foundational helping skills that have been identified via the brief role-play assessments.
|
Each site will implement three waves of Foundational Helping Skills training.
Each training will include 12 trainees each, with a minimum of 2 trainers per training.
Each site will include pre and post research days, where they will collect primary and secondary outcomes with support from research staff (trained raters, actors, and qualitative researcher).
Each site will qualitatively assess the training after the first wave to identify any areas for modification, and after the second and third waves to develop recommendations for future implementation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Enhancing Assessment of Common Therapeutic Factors; Unabbreviated scale title: "Enhancing Assessment of Common Therapeutic Factors"
Time Frame: immediately after the foundational helping skills training
|
15-item objective structured clinical examination using a role play, minimum value = 15, maximum value = 60, higher score means greater competency
|
immediately after the foundational helping skills training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foundation Helping Skills Knowledge Test; Unabbreviated scale title: "Foundation Helping Skills Knowledge Test"
Time Frame: immediately after the foundational helping skills training
|
Multiple choice test for each of the common factors competencies; minimum value=0, maximum value = 30, scores are reported of percentages of total, minimum = 0%, maximum = 100%, higher scores mean more knowledge of foundational helping skills
|
immediately after the foundational helping skills training
|
Counselor Activity Self-Efficacy Scales; Unabbreviated scale title: "Counselor Activity Self-Efficacy Scales"
Time Frame: immediately after the foundational helping skills training
|
15-item self-efficacy scale for counseling skills; minimum value = 0, maximum value = 135, higher scores mean more perceived self-efficacy in counselor skills
|
immediately after the foundational helping skills training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alison Schafer, PhD, World Health Organization
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 20, 2020
Primary Completion (ACTUAL)
January 31, 2021
Study Completion (ACTUAL)
January 31, 2021
Study Registration Dates
First Submitted
July 29, 2020
First Submitted That Met QC Criteria
August 11, 2020
First Posted (ACTUAL)
August 13, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 28, 2022
Last Update Submitted That Met QC Criteria
September 27, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EQUIP-FHS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data will be shared after publication of primary results.
IPD Sharing Time Frame
Materials will be shared after publication of primary results.
IPD Sharing Access Criteria
Contact investigators.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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