Serious Emotional DisturbancePIIKIPPNCT02152618
Kansas Intensive Permanency Project
A study testing Parent Management Training - Oregon Model (PMTO) in people with Serious Emotional Disturbance and In Foster Care, run by Westat.
Trial summary
The intervention provides services to children with Serious Emotional Disturbance (SED) who are in foster care and to their parent(s) to prepare the families for reunification. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Serious Emotional Disturbance, In Foster Care
- What is being tested?
- Parent Management Training - Oregon Model (PMTO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,652 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Nov 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age 3-16 with severe emotional disturbances
- In foster care and their families (parents).
Who cannot join
- -
About this study
Official title: Permanency Innovations Initiative- Kansas Intensive Permanency Project
The intervention provides services to children with Serious Emotional Disturbance (SED) who are in foster care and to their parent(s) to prepare the families for reunification.
Read the detailed description
The intervention provide services to children with Serious Emotional Disturbance (SED) who are in foster care and to their birth parents to prepare the families for reunification. The evaluation follows a randomized design. The pretest will assess the procedures and instruments for collecting data on child, youth, and family functioning. Ultimately, after the pretest is complete, the data collected through the evaluation will provide information on the extent to which the intervention achieved its goal of improving parenting skills and enhancing readiness for reunification among the families who received the services.
- Conditions
- Serious Emotional Disturbance, In Foster Care
- Being tested
- Parent Management Training - Oregon Model (PMTO)
- Keywords
- Serious emotional disturbance, foster care, child protective services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Management Training - Oregon Model (PMTO)Other
Evidence-based, behavioral parent management training model, Parent Management Training - Oregon Model (PMTO) tailored to address permanency barriers of parents of children with SED.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Other: Parent Management Training - Oregon Model (PMTO) |
| 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
Positive parenting behaviors
Measured by administering two standardized instruments: 1) the Caregiver Wish List (CWL); and, 2) the Family Interaction Task (FIT).
Measured: Pre intervention, post intervention and at 12-months
Secondary outcomes (10)
Use of community resources & social supports
Measured by observing the results of a subscale of a standardized instrument, the North Carolina Family Assessment Scale, General and Reunification services (NCFAS-G+R). The subscale is identified as "social/community life."
Measured: Pre intervention, post intervention and at 12-months
Readiness for Reunification
Measured by the "readiness for reunification" subscale of the North Carolina Family Assessment Scale, General and Reunification services (NCFAS-G+R).
Measured: Pre intervention, post intervention and at 12-months
Improve parent mental health & Substance Abuse
Measured by the relevant items on the North Carolina Family Assessment Scale, General and Reunification services (NCFAS-G+R).
Measured: Pre intervention, post intervention and at 12-months
Child behavior
Measured with Social Skills Improvement System rating scales (SSIS).
Measured: Intake & every 6-months post intake
Child functioning
Measured by assessing the child's functioning with the Child and Adolescent Functional Assessment Scale (CAFAS) for school-aged children and the Preschool and Early Childhood Functional Assessment Scale (PECFAS) for preschool-aged children.
Measured: Intake & every 6-months post intake
Reunification
Measured using data from Kansas' state administrative database for child welfare as reported to AFCARS/NCANDS.
Measured: 18 months post intervention start date
Long-term foster care
Measured by using data from Kansas' state administrative database for child welfare as reported to AFCARS/NCANDS.
Measured: Measured at 6 and 12 months post entry into foster care
Stable permanency
Measured by using data from Kansas' state administrative database for child welfare as reported to AFCARS/NCANDS.
Measured: Measured at 6 and 12 months post entry into foster care
Child safety
Measured by using data from Kansas' state administrative database for child welfare as reported to AFCARS/NCANDS.
Measured: Measured at 6 and 12 months post entry into foster care
Coercive parenting practices
Measured by administering two standardized instruments: 1) the Caregiver Wish List (CWL); and, 2) the Family Interaction Task (FIT).
Measured: Pre intervention, post intervention and at 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startSep 2010
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious Emotional DisturbanceStudies 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
- Masking
- None (open label)
- Enrolment
- 1,652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westat
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Bureau ACYF, Office of Planning, Research & Evaluation, University of Kansas School of Social Welfare
- Responsible party
- Sponsor
- Investigators
- Mark Testa, PhD., Principal investigator, University of North CarolinaAndrea Sedlak, PhD., Study director, Westat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152618
- Sponsor's protocol ID
- HHSP23320095655WC-KS
- Acronym
- PIIKIPP
- Status last verified
- Mar 2019
- First submitted
- 14 Apr 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- Kansas Intensive Permanency Project
- ClinicalTrials.gov ID
- NCT02152618
- Acronym / sponsor ID
- PIIKIPP / HHSP23320095655WC-KS
- Conditions
- Serious Emotional Disturbance, In Foster Care
- Keywords
- Serious emotional disturbance, foster care, child protective services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,652 participants (actual)
- Lead sponsor
- WestatUniversity, hospital or other
- Collaborators
- Children's Bureau ACYF, Office of Planning, Research & Evaluation, University of Kansas School of Social Welfare
- Study start
- Sep 2010
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 2 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 intervention provides services to children with Serious Emotional Disturbance (SED) who are in foster care and to their parent(s) to prepare the families for reunification.
Detailed description
The intervention provide services to children with Serious Emotional Disturbance (SED) who are in foster care and to their birth parents to prepare the families for reunification. The evaluation follows a randomized design. The pretest will assess the procedures and instruments for collecting data on child, youth, and family functioning. Ultimately, after the pretest is complete, the data collected through the evaluation will provide information on the extent to which the intervention achieved its goal of improving parenting skills and enhancing readiness for reunification among the families who received the services.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Parent Management Training - Oregon Model (PMTO) |
| Comparison | No intervention | – |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children age 3-16 with severe emotional disturbances
- In foster care and their families (parents).
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 |
|---|---|---|
| Parent Management Training - Oregon Model (PMTO)Evidence-based, behavioral parent management training model, Parent Management Training - Oregon Model (PMTO) tailored to address permanency barriers of parents of children with SED. | 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)
Positive parenting behaviors
Time frame: Pre intervention, post intervention and at 12-months
Measured by administering two standardized instruments: 1) the Caregiver Wish List (CWL); and, 2) the Family Interaction Task (FIT).
10 secondary outcomes
Use of community resources & social supports
Time frame: Pre intervention, post intervention and at 12-months
Readiness for Reunification
Time frame: Pre intervention, post intervention and at 12-months
Improve parent mental health & Substance Abuse
Time frame: Pre intervention, post intervention and at 12-months
Child behavior
Time frame: Intake & every 6-months post intake
Child functioning
Time frame: Intake & every 6-months post intake
Reunification
Time frame: 18 months post intervention start date
Long-term foster care
Time frame: Measured at 6 and 12 months post entry into foster care
Stable permanency
Time frame: Measured at 6 and 12 months post entry into foster care
Child safety
Time frame: Measured at 6 and 12 months post entry into foster care
Coercive parenting practices
Time frame: Pre intervention, post intervention and at 12-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.
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.
Mark Testa, PhD. principal investigator
University of North Carolina
Andrea Sedlak, PhD. study director
Westat
Questions about this trial
What is this clinical trial studying?
A study testing Parent Management Training - Oregon Model (PMTO) in people with Serious Emotional Disturbance 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.