Trial record 4 of 246 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03651050
Recruitment Status : Not yet recruiting
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Information provided by (Responsible Party):
New York University School of Medicine

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 331 participants
Allocation: Randomized
Intervention Model: Single Group 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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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

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 ]

Information from the National Library of Medicine

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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

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.

Responsible Party: New York University School of Medicine Identifier: NCT03651050     History of Changes
Other Study ID Numbers: 18-00728
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

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