NCT04511156

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

July 29, 2020

Last Update Submit

September 27, 2022

Conditions

Keywords

CompetencyTrainingCommunication skillsEmpathy

Outcome Measures

Primary Outcomes (1)

  • Enhancing Assessment of Common Therapeutic Factors; Unabbreviated scale title: "Enhancing Assessment of Common Therapeutic Factors"

    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 Outcomes (2)

  • Foundation Helping Skills Knowledge Test; Unabbreviated scale title: "Foundation Helping Skills Knowledge Test"

    immediately after the foundational helping skills training

  • Counselor Activity Self-Efficacy Scales; Unabbreviated scale title: "Counselor Activity Self-Efficacy Scales"

    immediately after the foundational helping skills training

Study Arms (1)

Foundational Helping Skills

EXPERIMENTAL

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

Interventions

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.

Foundational Helping Skills

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Transcultural Psychosocial Organization Nepal

Kathmandu, Nepal

Location

Socios en Salud Sucursal Peru

Lince, 15046, Peru

Location

HealthRight International Uganda

Kampala, Uganda

Location

Study Officials

  • Alison Schafer, PhD

    World Health Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Raters of competency will watch video-taped role plays and they will be blinded as to whether the role plays were conducted pre- or post-training.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This study is a single group, multi-site, uncontrolled before- and-after trial, which will evaluate the effectiveness of a training intervention to improve foundational helping skills in non-specialists naïve to mental health and psychosocial support. We will compare change in trainees' foundational helping skills competency scores from pre-training (baseline) to post-training, as well as knowledge, attitude, and self-efficacy scores. We will also explore the feasibility, acceptability, and perceived benefit of the Foundational Helping Skills training package for remote and in-person delivery. The study will be conducted in three country settings, Nepal, Perú and Uganda. The study design will be the same in all three country sites.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 13, 2020

Study Start

October 20, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data will be shared after publication of primary results.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Materials will be shared after publication of primary results.
Access Criteria
Contact investigators.

Locations