CClinicalTrials.gg
Status unknownNCT04221633NavE3Updated Jan 13, 2021

R34 Family Navigator Enhancing Early Engagement

An interventional study of Enhancing Early Engagement (E3) webinar and Consultation for E3 training in Mental Health Issue and Trauma, Psychological, sponsored by University of Oklahoma. Status unknown at 2 sites in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-13.

Sponsored by University of Oklahoma · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
297
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
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Study 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.

Read the 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

02

Conditions studied

  • Mental Health Issue
  • Trauma, Psychological

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03

In context

Psychological Trauma

139 studies on the registry are indexed under Psychological Trauma; 41 are open to participants now.

This study's enrollment of 297 is above the median of 80 across 105 interventional studies indexed under Psychological Trauma.

Browse Psychological Trauma studies →

Lead sponsor

University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • There are no specific exclusion criteria
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
297 participants (actual)

Study arms

  • Experimental
    Webinar only

    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.

    Behavioral: Enhancing Early Engagement (E3) webinar

  • Experimental
    Webinar plus consultation

    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.

    Behavioral: Enhancing Early Engagement (E3) webinar · Behavioral: Consultation for E3 training

  • No intervention
    Delayed training group

    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.

Interventions

  • BehavioralEnhancing 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.

  • BehavioralConsultation for E3 training

    10 consultation calls with experts in engagement, child trauma, and mental health screening to support the webinar training

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Tracked over the course of one year for all families seen at the CAC.

  2. 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

    Time frame: Through study completion, up to one year

  3. 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)

    Time frame: Through study completion, up to one year

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Study locations

2 sites
  • National Children's Alliance
    Washington, District of Columbia 20002, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73117, United States
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References and documents

Publications

  • 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. PubMed 34872619 ↗

Individual participant data

Plan to share: Undecided — Currently working with NIMH to determining data archiving process.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04221633
Lead sponsor
University of Oklahoma
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Jan 9, 2020
Start date
Dec 11, 2019
Primary completion
Jan 4, 2021
Completion
Oct 30, 2021 (estimated)
Last update
Jan 13, 2021

Study contacts

Jane F Silovsky, Ph.D.
principal investigator · University of Oklahoma

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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