Mental Health IssueNavE3NCT04221633
R34 Family Navigator Enhancing Early Engagement
A study testing Enhancing Early Engagement (E3) webinar and Consultation for E3 training in people with Mental Health Issue and Trauma, Psychological, run by University of Oklahoma at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Trauma, Psychological
- What is being tested?
- Enhancing Early Engagement (E3) webinar and Consultation for E3 training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Dec 2019to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- There are no specific exclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
National Children's Alliance
Washington D.C., District of Columbia, 20002
About this study
Official title: R34 Family Navigator E3 Project: Enhance Early Engagement in Mental Health Services Through Children's Advocacy Center's Family Advocates
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
- Conditions
- Mental Health Issue, Trauma, Psychological
- Being tested
- Enhancing Early Engagement (E3) webinar, Consultation for E3 training
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhancing Early Engagement (E3) webinarBehavioural
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 trainingBehavioural
10 consultation calls with experts in engagement, child trauma, and mental health screening to support the webinar training
| Study group | Role | What they receive |
|---|---|---|
| Webinar only | Experimental | 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. Receives: Behavioral: Enhancing Early Engagement (E3) webinar |
| Webinar plus consultation | Experimental | 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. Receives: Behavioral: Enhancing Early Engagement (E3) webinar; Behavioral: Consultation for E3 training |
| Delayed training group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Tracked over the course of one year for all families seen at 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
Measured: Through study completion, up to one year
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)
Measured: Through study completion, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start11 Dec 2019
- Primary completion4 Jan 2021
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jane F Silovsky, Ph.D., Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221633
- Sponsor's protocol ID
- 11290
- Other IDs
- R34MH118486
- Acronym
- NavE3
- Status last verified
- Jan 2021
- First submitted
- 13 Dec 2019
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently working with NIMH to determining data archiving process.
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R34 Family Navigator E3 Project: Enhance Early Engagement in Mental Health Services Through Children's Advocacy Center's Family Advocates
- ClinicalTrials.gov ID
- NCT04221633
- Acronym / sponsor ID
- NavE3 / 11290
- Conditions
- Mental Health Issue, Trauma, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 297 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 4 Jan 2021 (actual)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The current clinical trial involves three conditions (N=25 each): webinar-training only, webinar training plus consultation, and waitlist control.
| Arm | Type | Receives |
|---|---|---|
| Webinar only | Experimental | Behavioral: Enhancing Early Engagement (E3) webinarParticipants 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. |
| Webinar plus consultation | Experimental | Behavioral: Enhancing Early Engagement (E3) webinar, Behavioral: Consultation for E3 trainingParticipants 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. |
| Delayed training group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhancing Early Engagement (E3) webinarWebinar-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. | Behavioural | Webinar only, Webinar plus consultation |
| Consultation for E3 training10 consultation calls with experts in engagement, child trauma, and mental health screening to support the webinar training | Behavioural | Webinar plus consultation |
Primary outcome
Rate of child engagement in mental health services
Time frame: Tracked over the course of one year for all families seen at the CAC.
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
Time frame: Through study completion, up to one year
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
Time frame: Through study completion, up to one year
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Derived from this study: PubMed 34872619Taylor 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.
- Individual participant dataSharing planned: Undecided. Currently working with NIMH to determining data archiving process.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane F Silovsky, Ph.D. principal investigator
University of Oklahoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhancing Early Engagement (E3) webinar and Consultation for E3 training in people with Mental Health Issue and Trauma, Psychological, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of child engagement in mental health services (time frame: Tracked over the course of one year for all families seen at the CAC.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04221633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.