R34 Family Navigator Enhancing Early Engagement

Mental Health Issue Clinical Trial

— NavE3  

Official title:

R34 Family Navigator E3 Project: Enhance Early Engagement in Mental Health Services Through Children's Advocacy Center's Family Advocates

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04221633
• Other study ID #: 11290
• Secondary ID: R34MH118486
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 11, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: January 2021
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 297
• Est. completion date: October 30, 2021
• Est. primary completion date: January 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Issue
• Psychological Trauma
• Trauma, Psychological

Intervention

Behavioral:
• Enhancing Early Engagement (E3) webinar
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.
• Consultation for E3 training
10 consultation calls with experts in engagement, child trauma, and mental health screening to support the webinar training

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	National Children's Alliance	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Tracked over the course of one year for all families seen at the CAC.
Primary	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	Through study completion, up to one year
Primary	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)	Through study completion, up to one year