Treatment as UsualNCT05954585
Family Navigator Intervention
A study testing Treatment as usual and Family Navigator in people with Treatment as Usual and Family Navigator, run by Rhode Island Hospital at 1 site in United States.
Trial summary
This study will develop and examine the feasibility and acceptability of a family navigator protocol while leveraging digital health communication. It will employ an ecological model within a socio-cultural theoretic framework of mental health service disparities and barriers to treatment. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Treatment as Usual, Family Navigator
- What is being tested?
- Treatment as usual and Family Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2023to 31 May 2024
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- youth 10 to 14 years old living at home with legal guardian/caregiver
Who cannot join
- presentation including psychosis, sexual assault, or child abuse,
- are in police or child protective services' custody,
- are unable to assent due to severity of illness or developmental disabilities, >cannot communicate in English or Spanish, or
- if no caregiver or legal guardian is able to provide consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: The Development of a Family Navigator Intervention and Prevention Protocol to Reduce Risk of Suicide and Self-injurious Behavior for Youth Aged 8 to 14 Years
This study will develop and examine the feasibility and acceptability of a family navigator protocol while leveraging digital health communication. It will employ an ecological model within a socio-cultural theoretic framework of mental health service disparities and barriers to treatment.
Read the detailed description
The purpose of this study is to develop and pilot a Family Navigator intervention with technology-enhanced information sharing for families with youth (80 youth-caregiver dyads) who were discharged from the emergency after an admission for SSIB. This novel intervention aims to reduce suicidal and non-suicidal self-injurious behavior risk and prevalence rates by way of increasing attendance to community-based mental health services for youth aged 10 to 14.
- Conditions
- Treatment as Usual, Family Navigator
- Being tested
- Treatment as usual, Family Navigator
- Keywords
- emergency department, suicide, youth, family navigator
- Medical subject headings
- Emergencies, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usualBehavioural
Emergency department treatment as usual
Family NavigatorBehavioural
Family Navigator will speak with families about individual and systemic issues for linkage to mental health care biweekly for 3 months or until the youth's first mental health appt has been attended, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Emergency department treatment as usual Receives: Behavioral: Treatment as usual |
| Family Navigator | Experimental | Follow provision provided by a Family Navigator for the length of the treatment or until youth attends community-based mental health care Receives: Behavioral: Family Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health Services
adapted CASA
Measured: 6 months
Secondary outcomes (2)
Suicidal ideation
Suicidal Ideation Questionnaire
Measured: 6 months
Suicidal behavior
Suicidal Ideation Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start2 Dec 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Why it stopped: Graduated off COBRE grant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment as UsualStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Kathryn Cancilliere, Rhode Island Hospital
- Investigators
- Mary Kathryn Cancilliere, PhD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954585
- Sponsor's protocol ID
- RIH.100
- Status last verified
- Feb 2025
- First submitted
- 12 Jul 2023
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a Family Navigator Intervention and Prevention Protocol to Reduce Risk of Suicide and Self-injurious Behavior for Youth Aged 8 to 14 Years
- ClinicalTrials.gov ID
- NCT05954585
- Acronym / sponsor ID
- RIH.100
- Conditions
- Treatment as Usual, Family Navigator
- Keywords
- emergency department, suicide, youth, family navigator
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Graduated off COBRE grant
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 20 Jul 2023 (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.
This study will develop and examine the feasibility and acceptability of a family navigator protocol while leveraging digital health communication. It will employ an ecological model within a socio-cultural theoretic framework of mental health service disparities and barriers to treatment.
Detailed description
The purpose of this study is to develop and pilot a Family Navigator intervention with technology-enhanced information sharing for families with youth (80 youth-caregiver dyads) who were discharged from the emergency after an admission for SSIB. This novel intervention aims to reduce suicidal and non-suicidal self-injurious behavior risk and prevalence rates by way of increasing attendance to community-based mental health services for youth aged 10 to 14.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Behavioral: Treatment as usualEmergency department treatment as usual |
| Family Navigator | Experimental | Behavioral: Family NavigatorFollow provision provided by a Family Navigator for the length of the treatment or until youth attends community-based mental health care |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- youth 10 to 14 years old living at home with legal guardian/caregiver
Key exclusion criteria (4 listed)
- presentation including psychosis, sexual assault, or child abuse,
- are in police or child protective services' custody,
- are unable to assent due to severity of illness or developmental disabilities, >cannot communicate in English or Spanish, or
- if no caregiver or legal guardian is able to provide consent.
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 |
|---|---|---|
| Treatment as usualEmergency department treatment as usual | Behavioural | Treatment as usual |
| Family NavigatorFamily Navigator will speak with families about individual and systemic issues for linkage to mental health care biweekly for 3 months or until the youth's first mental health appt has been attended, whichever comes first. | Behavioural | Family Navigator |
Primary outcome
Mental Health Services
Time frame: 6 months
adapted CASA
2 secondary outcomes
Suicidal ideation
Time frame: 6 months
Suicidal behavior
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Graduated off COBRE grant). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Mary Kathryn Cancilliere, PhD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual and Family Navigator in people with Treatment as Usual and Family Navigator, run by Rhode Island Hospital at 1 site 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Graduated off COBRE grant). 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?
Mental Health Services (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2025.