At Risk for FosterNCT02173314
Nevada Initiative to Reduce Long-Term Foster Care
A study testing SAFE FC in people with At Risk for Foster and In Foster Care, run by Westat.
Trial summary
The evaluation of the Nevada Initiative to Reduce Long-Term Foster Care (LTFC) includes three populations. It will examine how the interventions SAFE- FC and FSE impact or relate to permanency outcomes for children most at risk for long term foster care and currently in care. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- At Risk for Foster, In Foster Care
- What is being tested?
- SAFE FC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 507 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Dec 2015
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children assessed to be unsafe via the Nevada Initial Assessment
- children in foster care with specific risk characteristics.
Who cannot join
- -
About this study
Official title: Permanency Innovations Initiative- Nevada Initiative to Reduce Long-Term Foster Care
The evaluation of the Nevada Initiative to Reduce Long-Term Foster Care (LTFC) includes three populations. It will examine how the interventions SAFE- FC and FSE impact or relate to permanency outcomes for children most at risk for long term foster care and currently in care.
Read the detailed description
The project targets three populations of children. For populations 1 and 2, the study will evaluate an intervention known as SAFE-FC. The intervention aims to prevent long term foster care by providing tailored services and intensive engagement with all new families with children identified as unsafe (Population 1) and for cases that are currently in care and at risk of LTFC where reunification is the case goal (Population 2). Family Search and Engagement (FSE) is the intervention for Population 3; it involves intense search practices to identify possible permanency resources. For Populations 1 and 2 the study is a randomized, intent-to-treat design to measure safety and permanency outcomes. For Population 3 the evaluation will be a descriptive study to analyze relationships between the intervention approach and outcomes. Both studies aim to examine how the interventions (SAFE- FC and FSE) impact or relate to permanency outcomes for children most at risk for long term foster care.
- Conditions
- At Risk for Foster, In Foster Care
- Being tested
- SAFE FC
- Keywords
- Long term foster care, child abuse and neglect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFE FCOther
Also called SAFE - FC, a combination of SAFE and Family Connections
SAFE - FC, a combination of SAFE (developed by ACTION for Child Protection) and Family Connections (developed by Ruth H. Young Center for Families and Children, University of Maryland School of Social Work) for Populations 1 and 2.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Other: SAFE FC |
| Comparison | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to stable permanence
Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS)
Measured: Measured from the date of random assignment to the discharge date or to the end of the study period for cases that did not discharge
Caregiver readiness for change
Measured with Readiness for Parenting Change Scale (REDI) Abbreviated (Chaffin et al, 2011)
Measured: Measured at intake, at 6 months, 12 months, 18 months, and again at case closure (participants will be followed throughout the duration of their involvement with Washoe County DSS which is on average 24 months)
Secondary outcomes (1)
Caregiver stress
Parenting Stress Index - Short Form (PSI-SF) (Abidin, 1983)
Measured: Measured at intake, at 6 months, 12 months, 18 months, and again at case closure (participants will be followed throughout the duration of their involvement with Washoe County DSS which is on average 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startSep 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for At Risk for FosterStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westat
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families
- Responsible party
- Sponsor
- Investigators
- Andrea Sedlak, PhD., Study director, WestatMark Testa, PhD., Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173314
- Sponsor's protocol ID
- 8977-2
- Status last verified
- Mar 2019
- First submitted
- 17 Jun 2014
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Permanency Innovations Initiative- Nevada Initiative to Reduce Long-Term Foster Care
- ClinicalTrials.gov ID
- NCT02173314
- Acronym / sponsor ID
- 8977-2
- Conditions
- At Risk for Foster, In Foster Care
- Keywords
- Long term foster care, child abuse and neglect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- WestatUniversity, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families
- Study start
- Sep 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Jun 2014 (estimated)
- 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.
The evaluation of the Nevada Initiative to Reduce Long-Term Foster Care (LTFC) includes three populations. It will examine how the interventions SAFE- FC and FSE impact or relate to permanency outcomes for children most at risk for long term foster care and currently in care.
Detailed description
The project targets three populations of children. For populations 1 and 2, the study will evaluate an intervention known as SAFE-FC. The intervention aims to prevent long term foster care by providing tailored services and intensive engagement with all new families with children identified as unsafe (Population 1) and for cases that are currently in care and at risk of LTFC where reunification is the case goal (Population 2). Family Search and Engagement (FSE) is the intervention for Population 3; it involves intense search practices to identify possible permanency resources. For Populations 1 and 2 the study is a randomized, intent-to-treat design to measure safety and permanency outcomes. For Population 3 the evaluation will be a descriptive study to analyze relationships between the intervention approach and outcomes. Both studies aim to examine how the interventions (SAFE- FC and FSE) impact or relate to permanency outcomes for children most at risk for long term foster care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: SAFE FC |
| Comparison | No intervention | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children assessed to be unsafe via the Nevada Initial Assessment
- children in foster care with specific risk characteristics.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| SAFE FCAlso: SAFE - FC, a combination of SAFE and Family ConnectionsSAFE - FC, a combination of SAFE (developed by ACTION for Child Protection) and Family Connections (developed by Ruth H. Young Center for Families and Children, University of Maryland School of Social Work) for Populations 1 and 2. | Other | Treatment |
Primary outcome
Time to stable permanence
Time frame: Measured from the date of random assignment to the discharge date or to the end of the study period for cases that did not discharge
Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS)
Caregiver readiness for change
Time frame: Measured at intake, at 6 months, 12 months, 18 months, and again at case closure (participants will be followed throughout the duration of their involvement with Washoe County DSS which is on average 24 months)
Measured with Readiness for Parenting Change Scale (REDI) Abbreviated (Chaffin et al, 2011)
1 secondary outcome
Caregiver stress
Time frame: Measured at intake, at 6 months, 12 months, 18 months, and again at case closure (participants will be followed throughout the duration of their involvement with Washoe County DSS which is on average 24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
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Tele-PCIT for Healthy Relationships in Families At-Risk
Disruptive Behavior, Pediatrics
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.
Andrea Sedlak, PhD. study director
Westat
Mark Testa, PhD. principal investigator
University of North Carolina
Questions about this trial
What is this clinical trial studying?
A study testing SAFE FC in people with At Risk for Foster and In Foster Care, run by Westat.
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 2 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: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to stable permanence (time frame: Measured from the date of random assignment to the discharge date or to the end of the study period for cases that did not discharge). The study lists 2 primary outcomes in all. 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 26 Mar 2019.