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Implementing a Digital Child Mental Health Screening, Literacy, and Management Tool in Faith-Based Settings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03651050
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : December 9, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mental Health Behavioral: Faith Based Outreach (FBO) Behavioral: community-health-workers (CHW) Not Applicable

Detailed Description:

The specific aims of this proposed study include:

Aim 1. To develop a P-MHDT (by employing qualitative focus-group interviews and user-centered design to enhance usability).

Aim 2. To train mental health professionals and community health workers (CHWs) for the P-MHDT approach of child mental health promotion in Uganda (including monitoring impacts of training on CHWs' program implementation competency).

Aim 3 (11-24 month). To estimate impacts of the P-MHDT on FBOs and families (i.e., caregivers' mental health literacy, practices, and children's mental health) when implemented in the real world FBO settings.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 319 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Implementing a Digital Child Mental Health Screening, Literacy, and Management Tool in Faith-Based Settings
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : August 30, 2020
Actual Study Completion Date : August 1, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: intervention FBOs receive the P-MHDT Behavioral: Faith Based Outreach (FBO)
Faith base outreach groups will be trained in P-MHDT
Experimental: control FBOs receive no P-MHDT Behavioral: community-health-workers (CHW)
COmmon health workers will be trained in P-MHDT


Outcome Measures
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Primary Outcome Measures :
  1. Aggression measured by parent report [ Time Frame: 24 Months ]
  2. Anxiety measured by parent report [ Time Frame: 24 Months ]
  3. Depression measured by parent report [ Time Frame: 24 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651050


Locations
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United States, New York
New York University Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Keng-Yen Huang, MD NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03651050    
Other Study ID Numbers: 18-00728
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: December 9, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No