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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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.

Study Locations

  • Nepal
      • Kathmandu, Nepal
        • Transcultural Psychosocial Organization Nepal
  • Peru
      • Lince, Peru, 15046
        • Socios En Salud Sucursal Peru
  • Uganda
      • Kampala, Uganda
        • HealthRight International Uganda

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Foundational Helping Skills
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
George Washington University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
World Health Organization
Transcultural Psychosocial Organization Nepal
Socios En Salud Sucursal, Peru
HealthRight International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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