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R34 Family Navigator Enhancing Early Engagement (NavE3)

Primary Purpose

Mental Health Issue, Trauma, Psychological

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhancing Early Engagement (E3) webinar
Consultation for E3 training
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Mental Health Issue

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Fully accredited by NCA
  • Directly provides EBP for child mental health or has established and demonstrated linkages for services in the community
  • Participates in OMS
  • Has Memorandum of Understanding (MOU) or data sharing agreements with all referral sources
  • Both CAC directors and Family Advocate(s) must demonstrate commitment to the training and data collection procedures.

Exclusion Criteria:

  • There are no specific exclusion criteria

Sites / Locations

  • National Children's Alliance
  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Webinar only

Webinar plus consultation

Delayed training group

Arm Description

Participants in this arm will attend a webinar training program (3 webinars over the course of 4 to 8 weeks) to receive training in evidence-based engagement strategies, trauma, evidence-based practices, and mental health screening.

Participants in this arm will receive the same webinar training as subjects in arm 1, but they will also receive 10 consultation calls over the course of four months to further develop their skills in engaging families and screening for mental health services.

This group will not receive any training for the duration of the study year, in order to serve as a waitlist control group. They will be eligible to receive the training after the randomized control trial has been completed.

Outcomes

Primary Outcome Measures

Rate of child engagement in mental health services
Caregiver report (via Outcome Management System [OMS] survey on a yes/no item) if family attended the first appointment of mental health services they were referred to be the CAC.
Score on 45-item Knowledge Assessment
Questionnaire of knowledge-based multiple choice and true/false questions, assessing knowledge of evidence-based engagement skills, trauma, evidence-based treatments, and mental health screening, yielding a total correct out of 45
Rate of evidence-based Engagement Skills survey
Advocate self-report of use of evidence-based engagement skills via a 39-item survey with skills utilized ranked on 5-point Likert scale (not at all to extensively); Caregiver report of advocate use of skills via three items on the OMS Survey, rating Advocate use of skills on a 4-point Likert scale (strongly agree to Strongly Disagree)

Secondary Outcome Measures

Full Information

First Posted
December 13, 2019
Last Updated
January 11, 2021
Sponsor
University of Oklahoma
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04221633
Brief Title
R34 Family Navigator Enhancing Early Engagement
Acronym
NavE3
Official Title
R34 Family Navigator E3 Project: Enhance Early Engagement in Mental Health Services Through Children's Advocacy Center's Family Advocates
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 11, 2019 (Actual)
Primary Completion Date
January 4, 2021 (Actual)
Study Completion Date
October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
For the current study, the investigators will develop, implement, and evaluate web-based and consultative training for Family Advocates employed at Children's Advocacy Centers (CACs) across the United States to enhance children's early engagement in evidence-based mental health treatment. The interactive web-based training will embed key targets of knowledge and skills related to family engagement, trauma, evidence-based practices (EBP), and EBP services in the community. Seventy-five CACs who apply to participate in training will be randomized to a webinar-only training group, a webinar plus consultation training group, and a delayed (waitlist) control group. It is hypothesized that the Family Advocates and CAC Directors will report high levels of satisfaction with the training. More importantly, it is also hypothesized that webinar training will improve Family Advocates' knowledge, resulting in minor improvement in EBP engagement, while the addition of consultation in the second training group will lead to increased use of engagement skills, thereby resulting in greater improvement in family engagement in EBP.
Detailed Description
Partnering with the accrediting board for CACs, the National Children's Alliance (NCA), the investigators will implement and evaluate training for Family Advocates to enhance early engagement in EBP (E3 training). Two levels of E3 training will be tested. The first level, webinar-only (E3w), will be web-based training on MH screening, EBP identification, trauma and effects of trauma, and engagement strategies that directly target known hindrances to accessing EBP in high risk, traumatized populations. The second level, webinar plus consultation (E3w+c), will add short-term consultation with experts in engagement and mental health. Consultation will target Family Advocates' skills in engagement, mental health screening, and coordination of care through strategies found to enhance skill acquisition. The investigators propose to test two key mechanisms of change for improving EBP engagement: knowledge (e.g., EBP identification) and skills (e.g., addressing caregiver perceptions of MH). To examine these change mechanisms, the investigators will implement the feasibility study designed to accomplish three tasks: (1) test if E3w training provides incremental benefits in engagement rates over the no training comparison group, (2) examine if E3w+c further improves outcomes beyond the E3w engagement rates and (3) examine mediating and moderating factors impacting outcome and implementation, including cost. The hypotheses that E3w will improve Family Advocates' knowledge, resulting in minor improvement in EBP engagement, and that addition of consultation in E3w+c will lead to increased use of engagement skills, resulting in greater improvement in family engagement in EBP, will be tested. Using NCA's innovative data capture systems, including the Outcome Management System (OMS; designed to obtain follow-up surveys from families and multidisciplinary team members), as well as a specific data tracking procedure using REDCap, the investigators will track case management details (including mental health needs and referrals) from each site randomized. In addition, knowledge learned via the training (pre- and post-knowledge assessments) will be tracked. In addition, NCA quantitative data on family engagement in EBP will be drawn, and the data submitted and integrated with pre- and post-training surveys of Family Advocates and CAC leaders measuring knowledge and perceptions of the training, including its utility, strengths, weaknesses, and costs. Applications were released to CACs nationwide in October of 2019, and sites were officially selected and randomized to groups using an adaptive randomization procedure such that a broad range of the selected covariates that are hypothesized to influence key outcomes occurs in all conditions. Participants from sites, including Advocates and Senior Leaders, will officially consent and enroll in the study in mid-December 2019. Participants will provide study data via an online data platform (i.e., REDCap). The outcomes of interest are the time-varying and CAC-varying provider fidelity and knowledge, as well as the family screening and engagement in treatment. Linear mixed effects models will be used to evaluate these outcomes, with generalized versions of these applied whenever the distribution of the outcome variable and the residuals suggest these to be appropriate

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue, Trauma, Psychological

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The current clinical trial involves three conditions (N=25 each): webinar-training only, webinar training plus consultation, and waitlist control.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
297 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Webinar only
Arm Type
Experimental
Arm Description
Participants in this arm will attend a webinar training program (3 webinars over the course of 4 to 8 weeks) to receive training in evidence-based engagement strategies, trauma, evidence-based practices, and mental health screening.
Arm Title
Webinar plus consultation
Arm Type
Experimental
Arm Description
Participants in this arm will receive the same webinar training as subjects in arm 1, but they will also receive 10 consultation calls over the course of four months to further develop their skills in engaging families and screening for mental health services.
Arm Title
Delayed training group
Arm Type
No Intervention
Arm Description
This group will not receive any training for the duration of the study year, in order to serve as a waitlist control group. They will be eligible to receive the training after the randomized control trial has been completed.
Intervention Type
Behavioral
Intervention Name(s)
Enhancing Early Engagement (E3) webinar
Intervention Description
Webinar-based training to provide information regarding evidence-based engagement strategies (e.g., motivational interviewing, McKay's engagement model), trauma, mental health screening, and identifying evidence-based mental health treatments for children.
Intervention Type
Behavioral
Intervention Name(s)
Consultation for E3 training
Intervention Description
10 consultation calls with experts in engagement, child trauma, and mental health screening to support the webinar training
Primary Outcome Measure Information:
Title
Rate of child engagement in mental health services
Description
Caregiver report (via Outcome Management System [OMS] survey on a yes/no item) if family attended the first appointment of mental health services they were referred to be the CAC.
Time Frame
Tracked over the course of one year for all families seen at the CAC.
Title
Score on 45-item Knowledge Assessment
Description
Questionnaire of knowledge-based multiple choice and true/false questions, assessing knowledge of evidence-based engagement skills, trauma, evidence-based treatments, and mental health screening, yielding a total correct out of 45
Time Frame
Through study completion, up to one year
Title
Rate of evidence-based Engagement Skills survey
Description
Advocate self-report of use of evidence-based engagement skills via a 39-item survey with skills utilized ranked on 5-point Likert scale (not at all to extensively); Caregiver report of advocate use of skills via three items on the OMS Survey, rating Advocate use of skills on a 4-point Likert scale (strongly agree to Strongly Disagree)
Time Frame
Through study completion, up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Fully accredited by NCA Directly provides EBP for child mental health or has established and demonstrated linkages for services in the community Participates in OMS Has Memorandum of Understanding (MOU) or data sharing agreements with all referral sources Both CAC directors and Family Advocate(s) must demonstrate commitment to the training and data collection procedures. Exclusion Criteria: There are no specific exclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane F Silovsky, Ph.D.
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Children's Alliance
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20002
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Currently working with NIMH to determining data archiving process.
Citations:
PubMed Identifier
34872619
Citation
Taylor EK, Dopp AR, Lounsbury K, Thompson Y, Miller M, Jorgensen A, Silovsky JF. Enhancing Early Engagement (E3) in mental health services training for children's advocacy center's victim advocates: feasibility protocol for a randomized controlled trial. Pilot Feasibility Stud. 2021 Dec 6;7(1):212. doi: 10.1186/s40814-021-00949-2.
Results Reference
derived

Learn more about this trial

R34 Family Navigator Enhancing Early Engagement

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