NCT03651050

Brief Summary

The proposed project is to develop a Pediatric-Mental Health Digital Toolkit (P-MHDT) Toolkit to support innovative child mental health preventive interventions in FBO settings. This project focuses on developing a P-MHDT and carrying out a pilot feasibility evaluation in real world settings. A group of Mental Health Professionals (MHPs)/ Community Healthcare Workers (CHWs) will be trained and the P-MHDT Toolkit intervention will be tested in 6 Faith Based Organizations (FBOs) in Uganda.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
319

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

December 9, 2021

Status Verified

December 1, 2021

Enrollment Period

1.1 years

First QC Date

August 27, 2018

Last Update Submit

December 8, 2021

Conditions

Mental Health

Outcome Measures

Primary Outcomes (3)

  • Aggression measured by parent report

    24 Months

  • Anxiety measured by parent report

    24 Months

  • Depression measured by parent report

    24 Months

Study Arms (2)

intervention FBOs receive the P-MHDT

EXPERIMENTAL
Behavioral: Faith Based Outreach (FBO)

control FBOs receive no P-MHDT

EXPERIMENTAL
Behavioral: community-health-workers (CHW)

Interventions

Faith Based Outreach (FBO)BEHAVIORAL

Faith base outreach groups will be trained in P-MHDT

intervention FBOs receive the P-MHDT
community-health-workers (CHW)BEHAVIORAL

COmmon health workers will be trained in P-MHDT

control FBOs receive no P-MHDT

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be at least 18 years of age. Participating parents must be caregivers of age 1-7 years old children.
  • Children are not the subjects of this study, and will not participate in research activities.

You may not qualify if:

  • Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.
  • Minors (age \<18) will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Allied Health PersonnelHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Keng-Yen Huang, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 29, 2018

Study Start

August 1, 2019

Primary Completion

August 30, 2020

Study Completion

August 1, 2021

Last Updated

December 9, 2021

Record last verified: 2021-12

Locations

US(1)