School ReadinessKITSNCT00688129
KITS: School Readiness in Foster Care Efficacy Trial
A study testing KITS Program in people with School Readiness, run by Oregon Social Learning Center at 1 site in United States.
Trial summary
The KITS project is a 5-year randomized trial to evaluate a program designed to enhance academic and social-emotional aspects of school readiness for foster preschoolers. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- School Readiness
- What is being tested?
- KITS Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to 31 Dec 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a child currently in foster care
- living in Lane or Marion County, Oregon
- eligible to enter Kindergarten in fall of assessment year (age 5 by September 1 of assessment year)
Who cannot join
- medical or developmental condition which would prevent the child from completing the assessment tasks
- current or previous involvement in Oregon Social Learning Center treatment programs
Trial locations and contacts
1 site in 1 country.
About this study
The KITS project is a 5-year randomized trial to evaluate a program designed to enhance academic and social-emotional aspects of school readiness for foster preschoolers.
Read the detailed description
The overarching goal of this research project is to conduct a randomized efficacy trial of a preventive intervention-the Kids in Transition to School (KITS) program-to enhance socioemotional and academic school readiness among preschool-aged foster children. Foster children are at great risk for poor social and academic school outcomes. Because of their experiences of early adversity, these children may have particular vulnerabilities that decrease the likelihood of a successful transition to school. Extensive prior research has shown that chronic early adversity is associated with alterations in the functioning of key neural systems (specifically, prefrontal cortex function and hypothalamic-pituitary-adrenal axis activity) related to self-regulation and stress reactivity. Alterations in these systems may interfere with children's abilities to relate to peers, to maintain focused attention, to follow directions, and to learn academic skills. Additionally, because these children are likely to have experienced multiple living transitions, they may be at a disadvantage in terms of caregiver involvement in school, a critical aspect of early school success. Foster children are recruited in the spring before they enter kindergarten and randomly assigned to the intervention and comparison conditions. The KITS intervention includes three components: (a) child therapeutic play groups to facilitate the development of self-regulatory, social, and emergent literacy skills; (b) a psychoeducational support group to promote caregiver involvement in the child's emergent literacy and schooling and the use of effective parenting techniques; (c) home- and school-based behavioral consultation. The intervention coincides with the transition into kindergarten. Multi-method, multi-agent assessments of the children's socioemotional readiness and literacy skills are conducted at baseline, kindergarten entry, and postkindergarten. We will examine the direct effects of the intervention on school readiness and kindergarten outcomes. We will also assess whether intervention effects are mediated through mechanisms of stress reactivity and regulation and caregiver variables. Finally, we will test for moderator effects of child and contextual characteristics including early adversity (prenatal/neonatal health, maltreatment history and placement history), child cognitive functioning, and placement transitions during the course of the study. An additional exploratory aim of the study is to examine intervention effects on first and second grade outcomes for subsamples of children. Group comparisons and longitudinal growth modeling will allow for evaluation of hypotheses.
- Conditions
- School Readiness
- Being tested
- KITS Program
- Keywords
- school readiness, foster care, maltreatment, literacy, social emotional skills, self regulation, caregiver involvement
- Medical subject headings
- Literacy, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KITS ProgramBehavioural
Also called Kids in Transition to School (KITS) Program
This is a 4-month psychosocial intervention for foster children entering kindergarten and their caregivers beginning the summer before kindergarten. The KITS intervention consists of: (a) child therapeutic play groups to facilitate the development of self-regulatory, social, and emergent literacy skills (2 times per week in summer, 1 times per week in the fall); (b) a bi-monthly psychoeducational support group to promote caregiver involvement in the child's emergent literacy and schooling and the use of effective parenting techniques; (c) home- and school-based behavioral consultation on an as needed basis.
| Study group | Role | What they receive |
|---|---|---|
| KITS Program | Experimental | The KITS intervention consists of: (a) child therapeutic play groups to facilitate the development of self-regulatory, social, and emergent literacy skills (2 times per week in summer, 1 times per week in the fall); (b) a bi-monthly psychoeducational support group to promote caregiver involvement in the child's emergent literacy and schooling and the use of effective parenting techniques; (c) home- and school-based behavioral consultation on an as needed basis. Receives: Behavioral: KITS Program |
| Services as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early literacy skills
Measured: pre-intervention, pre-kindergarten, end of kindergarten
Social skills
Measured: pre-intervention, pre-kindergarten, end of kindergarten
Regulatory skills
Measured: pre-intervention, pre-kindergarten, end of kindergarten
Caregiver involvement
Measured: pre-intervention, pre-kindergarten, end of kindergarten
Secondary outcomes (2)
Academic achievement
Measured: post-kindergarten, post 1st grade, post 2nd grade
Peer relations
Measured: post 1st grade, post 2nd grade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startSep 2005
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for School ReadinessStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Social Learning Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Katherine C. Pears, Oregon Social Learning Center
- Investigators
- Katherine C Pears, PhD, Principal investigator, Oregon Social Learning Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688129
- Sponsor's protocol ID
- R01DA021424
- Other IDs
- R01DA021424
- Acronym
- KITS
- Status last verified
- Sep 2017
- First submitted
- 28 May 2008
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Pears KC, Fisher PA, Bronz KD. An Intervention to Promote Social Emotional School Readiness in Foster Children: Preliminary Outcomes From a Pilot Study. School Psych Rev. 2007;36(4):665-673.
PubMed 19057655Pears KC, Fisher PA, Kim HK, Bruce J, Healey CV, Yoerger K. Immediate Effects of a School Readiness Intervention for Children in Foster Care. Early Educ Dev. 2013 Aug;24(6):771-791. doi: 10.1080/10409289.2013.736037.
PubMed 24015056Pears KC, Kim HK, Fisher PA. Effects of a School Readiness Intervention for Children in Foster Care on Oppositional and Aggressive Behaviors in Kindergarten. Child Youth Serv Rev. 2012 Dec;34(12):2361-2366. doi: 10.1016/j.childyouth.2012.08.015. No abstract available.
PubMed 23710106
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KITS: School Readiness in Foster Care Efficacy Trial
- ClinicalTrials.gov ID
- NCT00688129
- Acronym / sponsor ID
- KITS / R01DA021424
- Conditions
- School Readiness
- Keywords
- school readiness, foster care, maltreatment, literacy, social emotional skills, self regulation, caregiver involvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Oregon Social Learning CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2005
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 2 Jun 2008 (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 KITS project is a 5-year randomized trial to evaluate a program designed to enhance academic and social-emotional aspects of school readiness for foster preschoolers.
Detailed description
The overarching goal of this research project is to conduct a randomized efficacy trial of a preventive intervention-the Kids in Transition to School (KITS) program-to enhance socioemotional and academic school readiness among preschool-aged foster children. Foster children are at great risk for poor social and academic school outcomes. Because of their experiences of early adversity, these children may have particular vulnerabilities that decrease the likelihood of a successful transition to school. Extensive prior research has shown that chronic early adversity is associated with alterations in the functioning of key neural systems (specifically, prefrontal cortex function and hypothalamic-pituitary-adrenal axis activity) related to self-regulation and stress reactivity. Alterations in these systems may interfere with children's abilities to relate to peers, to maintain focused attention, to follow directions, and to learn academic skills. Additionally, because these children are likely to have experienced multiple living transitions, they may be at a disadvantage in terms of caregiver involvement in school, a critical aspect of early school success. Foster children are recruited in the spring before they enter kindergarten and randomly assigned to the intervention and comparison conditions. The KITS intervention includes three components: (a) child therapeutic play groups to facilitate the development of self-regulatory, social, and emergent literacy skills; (b) a psychoeducational support group to promote caregiver involvement in the child's emergent literacy and schooling and the use of effective parenting techniques; (c) home- and school-based behavioral consultation. The intervention coincides with the transition into kindergarten. Multi-method, multi-agent assessments of the children's socioemotional readiness and literacy skills are conducted at baseline, kindergarten entry, and postkindergarten. We will examine the direct effects of the intervention on school readiness and kindergarten outcomes. We will also assess whether intervention effects are mediated through mechanisms of stress reactivity and regulation and caregiver variables. Finally, we will test for moderator effects of child and contextual characteristics including early adversity (prenatal/neonatal health, maltreatment history and placement history), child cognitive functioning, and placement transitions during the course of the study. An additional exploratory aim of the study is to examine intervention effects on first and second grade outcomes for subsamples of children. Group comparisons and longitudinal growth modeling will allow for evaluation of hypotheses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KITS Program | Experimental | Behavioral: KITS ProgramThe KITS intervention consists of: (a) child therapeutic play groups to facilitate the development of self-regulatory, social, and emergent literacy skills (2 times per week in summer, 1 times per week in the fall); (b) a bi-monthly psychoeducational support group to promote caregiver involvement in the child's emergent literacy and schooling and the use of effective parenting techniques; (c) home- and school-based behavioral consultation on an as needed basis. |
| Services as usual | No intervention | – |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- a child currently in foster care
- living in Lane or Marion County, Oregon
- eligible to enter Kindergarten in fall of assessment year (age 5 by September 1 of assessment year)
Key exclusion criteria (2 listed)
- medical or developmental condition which would prevent the child from completing the assessment tasks
- current or previous involvement in Oregon Social Learning Center treatment programs
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 |
|---|---|---|
| KITS ProgramAlso: Kids in Transition to School (KITS) ProgramThis is a 4-month psychosocial intervention for foster children entering kindergarten and their caregivers beginning the summer before kindergarten. The KITS intervention consists of: (a) child therapeutic play groups to facilitate the development of self-regulatory, social, and emergent literacy skills (2 times per week in summer, 1 times per week in the fall); (b) a bi-monthly psychoeducational support group to promote caregiver involvement in the child's emergent literacy and schooling and the use of effective parenting techniques; (c) home- and school-based behavioral consultation on an as needed basis. | Behavioural | KITS Program |
Primary outcome
Early literacy skills
Time frame: pre-intervention, pre-kindergarten, end of kindergarten
Social skills
Time frame: pre-intervention, pre-kindergarten, end of kindergarten
Regulatory skills
Time frame: pre-intervention, pre-kindergarten, end of kindergarten
Caregiver involvement
Time frame: pre-intervention, pre-kindergarten, end of kindergarten
2 secondary outcomes
Academic achievement
Time frame: post-kindergarten, post 1st grade, post 2nd grade
Peer relations
Time frame: post 1st grade, post 2nd grade
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 19 Sep 2017.
- Background: PubMed 19057655Pears KC, Fisher PA, Bronz KD. An Intervention to Promote Social Emotional School Readiness in Foster Children: Preliminary Outcomes From a Pilot Study. School Psych Rev. 2007;36(4):665-673.
- Background: PubMed 24015056Pears KC, Fisher PA, Kim HK, Bruce J, Healey CV, Yoerger K. Immediate Effects of a School Readiness Intervention for Children in Foster Care. Early Educ Dev. 2013 Aug;24(6):771-791. doi: 10.1080/10409289.2013.736037.
- Background: PubMed 23710106Pears KC, Kim HK, Fisher PA. Effects of a School Readiness Intervention for Children in Foster Care on Oppositional and Aggressive Behaviors in Kindergarten. Child Youth Serv Rev. 2012 Dec;34(12):2361-2366. doi: 10.1016/j.childyouth.2012.08.015. No abstract available.
- Oregon Social Learning Center websiteLink provided by the sponsor.
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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.
Katherine C Pears, PhD principal investigator
Oregon Social Learning Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KITS Program in people with School Readiness, run by Oregon Social Learning Center 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 3 inclusion and 2 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 19 Sep 2017. 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 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?
Early literacy skills (time frame: pre-intervention, pre-kindergarten, end of kindergarten). The study lists 4 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 NCT00688129, which also lists 3 linked publications.
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 19 Sep 2017.