Ensuring Quality in Psychological Support

NCT04704362 | Completed

• 1 other identifier: NCR191797
• Study Type: interventional
• Target: 896
• Locations: 7 countries
• Sites: 7

Brief 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.

Conditions

Psychological Distress; Depression

Keywords

Training; Competency; Mental health; Psychological treatment

Outcome Measures

Primary Outcomes (1)

• Trainee - 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

  Post-intensive supervision (approximately 1 month post-training)

Secondary Outcomes (7)

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

  immediately after the manualized psychological treatment training

• Trainee - Trainer Subjective Rating of Competency; unabbrievated scale title "Trainer Subjective Rating of Competency"

  immediately after the manualized psychological treatment training

• Trainer's subjective competency rating of trainee on a scale from 1 to 4, with higher scores reflecting greater competency.

  Post-intensive supervision (approximately 1 month post-training)

• Trainee - Equip-Treatment-specific competencies; unabbreviated title "Ensuring Quality in Psychological Support Treatment Specific Competency"

  Immediate post-training (last day of training on manualized intervention)

• Trainee - Equip-Treatment-specific competencies; unabbreviated title "Ensuring Quality in Psychological Support Treatment Specific Competency"

  Post-intensive supervision (approximately 1 month post-training)

Study Arms (2)

Training and Supervision as Usual

ACTIVE COMPARATOR

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.

Behavioral: Standard Training and Supervision

Competency-based Training and Supervision

EXPERIMENTAL

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.

Behavioral: Ensuring Quality in Psychological Support

Interventions

Ensuring Quality in Psychological Support 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.

Competency-based Training and Supervision

Standard Training and Supervision BEHAVIORAL

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

Training and Supervision as Usual

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• George Washington University: lead
• World Health Organization: collaborator
• The Center for Victims of Torture, United States: collaborator
• University of Washington: collaborator
• University of Nairobi: collaborator
• War Child Holland: collaborator
• Socios En Salud Sucursal, Peru: collaborator
• University of South Florida: collaborator
• HealthRight International: collaborator
• Johns Hopkins University: collaborator
• Centre for Infectious Disease Research in Zambia: collaborator
• The University of New South Wales: collaborator

Study Sites (7)

Center for Victims of Torture

Addis Ababa, Ethiopia

Location

Institute for Family Health

Amman, Jordan

Location

University of Nairobi

Nairobi, Kenya

Location

War Child Holland

Beirut, Lebanon

Location

Socios en Salud Sucursal Peru

Lince, 15046, Peru

Location

HealthRight International Uganda

Kampala, Uganda

Location

Centre for Infectious Disease Research in Zambia

Lusaka, 10101, Zambia

Location

MeSH Terms

Conditions

Depression; Psychological Well-Being

Interventions

Organization and Administration

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Health Services Administration

Study Officials

• Alison Schafer, PhD

  World Health Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Trainees and their patients will not be told which arm the trainee was in. Outcome assessors will also be blinded to arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: January 11, 2021
• Study Start: June 20, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Individual participant data will be shared after completion of primary outcome publications from all sites.
• Access Criteria: Contact principal investigator.

Locations

ZA (1); KE (1); ET (1); PE (1); UG (1); LE (1); JO (1)