Ensuring Quality in Psychological Support

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

896 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-20

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this project is to test tools that will be part of a platform for training and supervision of mental health and psychosocial support helpers, including providers without specialized training in mental health. This platform, entitled Ensuring Quality in Psychological Support, is an online resource being developed to include: materials for evaluating core and specific competencies, training on core competencies, implementation guidance to conduct competency-based training. The Ensuring Quality in Psychological Support platform is designed to aid trainers and supervisors working with providers being trained to deliver World Health Organization and non-World Health Organization low-intensity psychological interventions. The research will address two study objectives: Objective 1. Determine feasibility, acceptability, and perceived utility of the Ensuring Quality in Psychological Support platform; Objective 2. Evaluate the reliability, validity, and sensitivity to change of Ensuring Quality in Psychological Support competency assessment tools. To maximize generalizability of findings, Ensuring Quality in Psychological Support will be evaluated in seven countries: Ethiopia, Kenya, Lebanon, Peru, Uganda, Zambia and Jordan. The sites are varied by types of psychological intervention, beneficiaries, experience of trainers, and background of trainees. In each site, trainers will train non-specialist providers on a low-intensity psychological intervention.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ensuring Quality in Psychological Support-Foundational Helping Skills

NCT04511156

Psychological Distress

COMPLETED NA

Examining Whether Project Support Works

NCT06963554

Parent-Child Relations Parenting Self Efficacy Child Mental Health

RECRUITING NA

Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda

NCT05863572

Psychosis

RECRUITING NA

Psychosocial Training for Pediatric Health Care Providers

NCT00070876

Mental Disorders Diagnosed in Childhood

COMPLETED NA

Improving Caregivers' Ability to Manage Life Stress

NCT05539352

Suicidal Ideation

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There is increasing evidence that non-specialist or minimally trained mental health providers can effectively provide support and deliver psychosocial support and low-intensity psychological interventions for common mental disorders and substance use disorders in low resource settings. Psychological treatments delivered by non-specialists in low-resource settings have effectiveness comparable to high-income country studies of specialist interventions.

Low intensity interventions refer to interventions that do not rely on specialists and are modified, brief evidence-based therapies including guide self-help and e-mental health. The World Health Organization identifies such interventions as being: brief, basic, non-specialist-delivered versions of existing evidence-based psychological treatments (e.g., basic versions of cognitive-behavioral therapy, interpersonal therapy); and may include self-help materials (e.g., self-help books, audiovisual materials, and online or app-based self-help interventions); individual or group programs, and designed to be age-appropriate (i.e., delivered differently for children and adults). Moreover, low intensity interventions are particularly well suited to communities affected by adversity, as they use fewer resources which make them more scalable.

Psychosocial refers to interventions that are designed to address the psychological effects of conflict \[or adversity\], including the effects on behavior, emotion, thoughts, memory and functioning, and social effects, including changes in relationships, social support and economic status. The term psychosocial emphasizes, the close connection between psychological aspects of experience and wider social aspects of experience, inclusive of human capacity, social ecology, and culture and values. For the purpose of this study, low intensity psychological and psychosocial interventions were selected using the criteria above, and ensuring the interventions are freely accessible to the public.

To assure success of such interventions outside the context of resource-intensive research trials, it is crucial to develop training and supervision programs that produce competent providers of psychological and psychosocial support interventions. A necessary element to achieve this goal is development of standardized tools and procedures to assess the competency of those trained to deliver them; while ensuring competency assessment results are easily understandable to trainers and supervisors so that they can remediate areas of low competency.

In the context of psychological and psychosocial interventions, competency refers the extent to which a therapist \[including non-specialists\] has the knowledge and skill required to deliver a treatment to the standard needed for it to achieve its expected effects. Competency is typically assessed through structured role-plays in which trained standardized \[mock\] clients elicit trainee's ability to perform the key skills of an intervention. Role-plays such as this are commonly used in health professional training and evaluation in the form of observed structured clinical evaluations with simulated patients. The Ensuring Quality in Psychological Support initiative was developed out of need to have easily implementable competency evaluation tools and remediation training materials that can be used with specialists and non-specialists in diverse global settings. To supplement the platform, Ensuring Quality in Psychological Support will also include various implementation, trainer and training resources and guidance.

The need for these competency assessment tools and training materials was identified in May 2018, during a Theory of Change Workshop conducted by the World Health Organization Ensuring Quality in Psychological Support team with frontline psychological service practitioners, clinicians, non-governmental organization training and supervision staff, and researchers. The four key elements of the platform will be (a) competency tools for evaluation of non-specific (core competencies or common factors) and specific practice elements (or treatment specific factors); (b) role-play vignettes for conducting competency evaluations; (c) instructional materials on how to conduct competency evaluations (training standardized clients, establishing inter-rater reliability when conducting competency evaluations, using rating tools, interpreting results); and (d) instructional materials on how to integrate competency evaluations into trainings and supervision (giving feedback to participants, modifying training programs, feedback to trainers and supervisors) including core competency training and remediation materials.

Study Goals and Objectives:

The goal of the study is to inform development of the Ensuring Quality in Psychological Support platform and its tools, ensuring feasibility, acceptability, utility, reliability, and validity to support the provision of quality psychological support.

Study Objectives

1. Determine the feasibility, acceptability, and perceived utility, of the Ensuring Quality in Psychological Support platform to facilitate assessment of competency and employ competency assessment results and remediation training materials to support training and supervision of non-specialists on low-intensity psychological interventions.
2. Evaluate the reliability, validity, and sensitivity to change of Ensuring Quality in Psychological Support competency assessment tools based on inter-rater reliability of the tools within and between sites, ability to detect changes in competency over the course of training and supervision, and association with trainer ratings, as well as service delivery metrics and client outcomes across different psychological interventions and implementation sites.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychological Distress Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is a non-randomized controlled trial comparing training and supervision as usual with training and supervision using a competency-based approach.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Trainees and their patients will not be told which arm the trainee was in. Outcome assessors will also be blinded to arm.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Training and Supervision as Usual

Non-specialists are trained in a psychological intervention under standard conditions. No feedback from competency-based evaluations is provided to modify the training or supervision curriculum.

Group Type ACTIVE_COMPARATOR

Standard Training and Supervision

Intervention Type BEHAVIORAL

Trainees are trained using a manual for non-specialist-delivered psychological interventions.

Competency-based Training and Supervision

Non-specialists are trained and supervised in a competency-based approach in which trainers and/or supervisors are provided with the competency scores of trainees in order to modify the training and supervision content and approach as needed.

Group Type EXPERIMENTAL

Ensuring Quality in Psychological Support

Intervention Type BEHAVIORAL

Trainees are evaluated with the Enhancing Assessment of Common Therapeutic factors structured role play tool and the results are shared with trainers and/or supervisors to modify training based on strengths and weakness on the competency scores.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ensuring Quality in Psychological Support

Trainees are evaluated with the Enhancing Assessment of Common Therapeutic factors structured role play tool and the results are shared with trainers and/or supervisors to modify training based on strengths and weakness on the competency scores.

Intervention Type BEHAVIORAL

Standard Training and Supervision

Trainees are trained using a manual for non-specialist-delivered psychological interventions.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Trainees: Non-specialist in mental health and psychosocial support
* Clients: Site-specific level of distress to determine psychological intervention participation

Exclusion Criteria

* Trainees: Unable to comprehend language that training and supervision will be conducted in
* Clients: Serious mental illness, developmental disability

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes