Foster CareNCT02193126
Trauma Focus Model for Reducing Long-Term Foster Care
A study testing Trauma Affect Regulation: Guide for Education and Therapy (TARGET) in people with Foster Care, run by Westat.
Trial summary
The Trauma Focus Model for Reducing Long-Term Foster Care Project with the Illinois Department of Children and Family Services (DCFS) is implementing a trauma-focused intervention, Trauma Affect Regulation: Guide for Education and Therapy (TARGET) to increase permanency rates for a target population of children… Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Foster Care
- What is being tested?
- Trauma Affect Regulation: Guide for Education and Therapy (TARGET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to May 2016
- 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth ages 11-16 who are placed in traditional, relative, and specialized foster homes throughout the state of Illinois who, upon reaching the two-year anniversary of entering care, are experiencing mental health symptoms and/or have had at least one placement change.
- If a youth does not exhibit any mental health symptoms as indicated by the Child and Adolescent Needs and Strength (CANS) tool, they need to have at least 3 placement changes to be eligible for the study.
Who cannot join
- Youth are ineligible to participate if at the time of eligibility assessment, they are in need of immediate and acute substance abuse treatment, have a Full Scale IQ score below 70, and/or have made recent suicidal threats or plans.
About this study
Official title: Permanency Innovations Initiative- Trauma Focus Model for Reducing Long-Term Foster Care Project
The Trauma Focus Model for Reducing Long-Term Foster Care Project with the Illinois Department of Children and Family Services (DCFS) is implementing a trauma-focused intervention, Trauma Affect Regulation: Guide for Education and Therapy (TARGET) to increase permanency rates for a target population of children identified as being most at risk of long-term foster care.
Read the detailed description
The Illinois Department of Children and Family Services (DCFS) is one of six recipients of the Permanency Innovations Initiative Grant. These funds support the statewide implementation of Trauma Affect Regulation: Guide for Education and Therapy (TARGET) in Illinois. TARGET is a manualized, psycho-educational intervention designed to address complex trauma and difficulties with emotional regulation and relational engagement that occur across a wide range of trauma-related difficulties, including trauma-related and behavioral symptoms. The aim of this intervention is to address the key barriers to permanence for the target population. This population includes youth ages 11-16 who are placed in traditional, relative, and specialized foster homes throughout the state of Illinois, have been in foster care for at least 2 years, and are experiencing mental health challenges and/or at least one placement change. The three key barriers to permanency are: (1) children's need to improve emotional regulation and reduce symptom severity, particularly disruptive behaviors; (2) biological parents' skills in regulating their emotions so they are better able to complete services and address the underlying issues related to their involvement in the child welfare system; (3) foster parents and other placement resources skills in understanding and addressing the needs and disruptive behaviors of the children in their care with trauma histories.
The local evaluation will examine the effectiveness of the TARGET program in increasing permanency rates for foster youth in the target population. The main hypothesis to be tested is that addressing unstable child affect \& behavior secondary to trauma using an intervention that improves both youth modulation skills as well as foster parent capacity to respond appropriately to youth will stabilize placements and improve youth ability to engage with potential permanency resources, thus facilitating progress toward permanence. The evaluation involves randomly assigning eligible foster youth to receive TARGET services or receive services as usual. The evaluators collect proximal and distal outcomes from multiple administrative data sources. Additionally, the evaluation includes the collection of key proximal outcomes through the use of interviews with foster youth, their foster parents and biological parents deemed eligible for participation in the project.
- Conditions
- Foster Care
- Being tested
- Trauma Affect Regulation: Guide for Education and Therapy (TARGET)
- Keywords
- Long term foster care, child abuse and neglect, trauma
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Affect Regulation: Guide for Education and Therapy (TARGET)Other
Also called TARGET
The intervention is called the Trauma Affect Regulation: Guide for Education and Therapy (TARGET). TARGET is a manualized, psycho-educational intervention delivered in 10 - 12 sessions. TARGET is designed to address complex trauma and difficulties with emotional regulation and relational engagement that occur across a wide range of trauma-related difficulties, including trauma-related and behavioral symptoms. The full TARGET model consists of learning 7 essential core skills. These skills are called the FREEDOM steps: Focus, Recognize triggers, Emotion self-check, Evaluate thoughts, Define goals, Options, and Make a contribution.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Other: Trauma Affect Regulation: Guide for Education and Therapy (TARGET) |
| 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
Placement stability
Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS)
Measured: Measured at initial study enrollment and at the 8, 14, 20, and 26-month mark of enrollment in the study
Secondary outcomes (1)
Foster parent skills in responding to youth's emotional and behavioral dysregulation
Measured by Parenting Practices Chicago Survey (PPCS) (Gorman-Smith et al., 1996)
Measured: completed by study youth at initial study enrollment and at 6 months after baseline data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foster CareStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westat
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families, Illinois Department of Children and Family Services.
- 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
- NCT02193126
- Sponsor's protocol ID
- 8977 3
- Status last verified
- Mar 2019
- First submitted
- 9 Jul 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- Trauma Focus Model for Reducing Long-Term Foster Care Project
- ClinicalTrials.gov ID
- NCT02193126
- Acronym / sponsor ID
- 8977 3
- Conditions
- Foster Care
- Keywords
- Long term foster care, child abuse and neglect, trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- WestatUniversity, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families, Illinois Department of Children and Family Services.
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Jul 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 Trauma Focus Model for Reducing Long-Term Foster Care Project with the Illinois Department of Children and Family Services (DCFS) is implementing a trauma-focused intervention, Trauma Affect Regulation: Guide for Education and Therapy (TARGET) to increase permanency rates for a target population of children identified as being most at risk of long-term foster care.
Detailed description
The Illinois Department of Children and Family Services (DCFS) is one of six recipients of the Permanency Innovations Initiative Grant. These funds support the statewide implementation of Trauma Affect Regulation: Guide for Education and Therapy (TARGET) in Illinois. TARGET is a manualized, psycho-educational intervention designed to address complex trauma and difficulties with emotional regulation and relational engagement that occur across a wide range of trauma-related difficulties, including trauma-related and behavioral symptoms. The aim of this intervention is to address the key barriers to permanence for the target population. This population includes youth ages 11-16 who are placed in traditional, relative, and specialized foster homes throughout the state of Illinois, have been in foster care for at least 2 years, and are experiencing mental health challenges and/or at least one placement change. The three key barriers to permanency are: (1) children's need to improve emotional regulation and reduce symptom severity, particularly disruptive behaviors; (2) biological parents' skills in regulating their emotions so they are better able to complete services and address the underlying issues related to their involvement in the child welfare system; (3) foster parents and other placement resources skills in understanding and addressing the needs and disruptive behaviors of the children in their care with trauma histories.
The local evaluation will examine the effectiveness of the TARGET program in increasing permanency rates for foster youth in the target population. The main hypothesis to be tested is that addressing unstable child affect \& behavior secondary to trauma using an intervention that improves both youth modulation skills as well as foster parent capacity to respond appropriately to youth will stabilize placements and improve youth ability to engage with potential permanency resources, thus facilitating progress toward permanence. The evaluation involves randomly assigning eligible foster youth to receive TARGET services or receive services as usual. The evaluators collect proximal and distal outcomes from multiple administrative data sources. Additionally, the evaluation includes the collection of key proximal outcomes through the use of interviews with foster youth, their foster parents and biological parents deemed eligible for participation in the project.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Trauma Affect Regulation: Guide for Education and Therapy (TARGET) |
| Comparison | No intervention | – |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Youth ages 11-16 who are placed in traditional, relative, and specialized foster homes throughout the state of Illinois who, upon reaching the two-year anniversary of entering care, are experiencing mental health symptoms and/or have had at least one placement change.
- If a youth does not exhibit any mental health symptoms as indicated by the Child and Adolescent Needs and Strength (CANS) tool, they need to have at least 3 placement changes to be eligible for the study.
Key exclusion criteria (1 listed)
- Youth are ineligible to participate if at the time of eligibility assessment, they are in need of immediate and acute substance abuse treatment, have a Full Scale IQ score below 70, and/or have made recent suicidal threats or plans.
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 |
|---|---|---|
| Trauma Affect Regulation: Guide for Education and Therapy (TARGET)Also: TARGETThe intervention is called the Trauma Affect Regulation: Guide for Education and Therapy (TARGET). TARGET is a manualized, psycho-educational intervention delivered in 10 - 12 sessions. TARGET is designed to address complex trauma and difficulties with emotional regulation and relational engagement that occur across a wide range of trauma-related difficulties, including trauma-related and behavioral symptoms. The full TARGET model consists of learning 7 essential core skills. These skills are called the FREEDOM steps: Focus, Recognize triggers, Emotion self-check, Evaluate thoughts, Define goals, Options, and Make a contribution. | 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)
Placement stability
Time frame: Measured at initial study enrollment and at the 8, 14, 20, and 26-month mark of enrollment in the study
Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS)
1 secondary outcome
Foster parent skills in responding to youth's emotional and behavioral dysregulation
Time frame: completed by study youth at initial study enrollment and at 6 months after baseline data collection
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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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 Trauma Affect Regulation: Guide for Education and Therapy (TARGET) in people with 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.