Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04704362 |
| Other study ID # |
NCR191797 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 20, 2020 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
September 2022 |
| Source |
George Washington University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
