School ReadinessKITS-PNNCT01806987
A Test of the Kids in Transition to School (KITS) Program in Disadvantaged Neighborhoods
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 purpose of this project to determine whether the KITS Program, an intervention to improve early literacy, prosocial and emotion and behavior regulation domains of school readiness, improves school readiness and school outcomes in children from socioeconomically disadvantaged neighborhoods. 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
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 31 Jan 2017
- 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
- Child is entering kindergarten in a disadvantaged neighborhood
- Child is a bilingual or monolingual English speaker
Who cannot join
- Child has a hearing or vision impairment that would limit participation in the intervention activities or assessment protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Efficacy Trial of the Kids in Transition to School (KITS) Program to Improve School Readiness of Children in Disadvantaged Communities
The purpose of this project to determine whether the KITS Program, an intervention to improve early literacy, prosocial and emotion and behavior regulation domains of school readiness, improves school readiness and school outcomes in children from socioeconomically disadvantaged neighborhoods.
Read the detailed description
PURPOSE: This project is a randomized efficacy trial of the KITS Program, an intervention to improve early literacy, prosocial and emotion and behavior regulation domains of school readiness, with children from socioeconomically disadvantaged neighborhoods. The project will extend the evidence on the efficacy of the intervention from two previous randomized efficacy trials of the KITS Program with special needs populations to examine the impacts of the intervention on the broader population of children from disadvantaged backgrounds in general education.
SETTING: The intervention will be conducted in elementary school classrooms in high-poverty, high-crime neighborhoods in a medium-sized metropolitan area of the Pacific Northwest during the summer before and the first 2 months of kindergarten.
POPULATION: This study involves the recruitment of 240 children who will be entering kindergarten in the fall and their families in three yearly cohorts (n = 80). The children will be recruited from neighborhoods that have been selected as some of the most disadvantaged in the state in terms of income and school readiness indicators.
INTERVENTION: The KITS Program is a high-intensity, short-term program timed to occur during the transition to kindergarten-a critical developmental milestone with far-reaching effects on school outcomes. The curriculum focuses on the early literacy, social, and self-regulation skills critical for success in kindergarten and on contextual characteristics (i.e., parent involvement in early literacy and positive parenting). KITS features 24 curriculum-based therapeutic playgroups focused on early literacy, social, and self-regulatory skills and 12 psychoeducational parent workshops focused on parent involvement in early literacy and positive parenting practices.
CONTROL CONDITION: The children in the services-as-usual condition will receive any early childhood learning services that they would typically receive prior to school entry. Services received will be assessed at each data time point.
RESEARCH DESIGN AND METHODS: The children will be randomly assigned to the KITS condition or a services-as-usual condition and assessed at four time points: spring prior to kindergarten, immediately prior to kindergarten entry, kindergarten fall, and kindergarten spring; 160 of the children will also be assessed in first grade spring.
MEASURES AND KEY OUTCOMES: Our multimethod, multi-informant outcome measures will include the following: direct assessments of early literacy and social-emotional skills prior to kindergarten and literacy skills and social-emotional functioning during kindergarten and first grade; parent and teacher reports on child skills and behaviors, parent involvement in early literacy and school, and parenting practices; direct classroom observations of child academic engaged time and social behaviors; and school records data on grades, office discipline referrals, special education services received, and attendance.
DATA-ANALYTIC STRATEGIES: Analyses will employ variable-centered (e.g., ANOVA and regression) and person-centered (e.g., latent growth curve modeling) approaches. Multilevel latent variable modeling will be used to test how changes in hypothesized mediators affect longer-term outcomes and how outcomes vary depending on level of hypothesized moderators.
- Conditions
- School Readiness
- Being tested
- KITS Program
- Keywords
- school readiness, literacy, social emotional skills, self regulation, caregiver involvement, socioeconomic disadvantage
- 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 Program
The KITS Program is a 4-month psychosocial intervention for children at high risk for school difficulties and their caregivers. The intervention begins in the summer before kindergarten and continues across the first two months of kindergarten. The KITS intervention consists of: (a) child school readiness play groups to facilitate the development of self-regulatory, social, and early literacy skills (2 times per week in summer, 1 time per week in the fall); and (b) a 12 session psychoeducational workshop to promote parent involvement in the child's early literacy and schooling and the use of effective parenting techniques (once per week in summer, bi-weekly in the fall).
| Study group | Role | What they receive |
|---|---|---|
| KITS Program | Experimental | The KITS Program consists of: (a) child school readiness play groups to facilitate the development of self-regulatory, social, and early literacy skills (2 times per week in summer, 1 time per week in the fall); and (b) a 12 session psychoeducational workshop to promote parent involvement in the child's early literacy and schooling and the use of effective parenting techniques (once per week in summer, bi-weekly in the fall). Receives: Behavioral: KITS Program |
| Services as usual | No intervention | These include any services that the child and family might already be receiving in the community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in early literacy skills from baseline to kindergarten fall
Standardized measures of early literacy skills including letter naming, phonological awareness and understanding of concepts about print
Measured: pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
Change in prosocial skills from baseline to kindergarten fall
Standardized direct assessments of the child's responses to social situations as well as parent and teacher responses to standardized questionnaires on children's social skills
Measured: pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
Change in emotion and behavior regulation skills from baseline to kindergarten fall
Standardized direct assessment of the children's executive function skills as well as parent and teacher report on standardized questionnaires used to assess emotion and behavior regulation
Measured: pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
Change in parenting behavior (parent involvement and positive parenting practices) from baseline to kindergarten fall
Caregiver reported involvement in early literacy activities and beliefs about the importance of various literacy skills for kindergarten as well as parenting practices
Measured: pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
Secondary outcomes (3)
Longitudinal academic achievement across grade levels
Standardized direct assessments of child achievement in reading and math as well as parent and teacher report on standardized measures of child achievement.
Measured: post-kindergarten (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)
Longitudinal social competence across grade levels
Standardized direct child assessments of responses to peer situations as well as child report on standardized questionnaires about social functioning at school and parent and teacher reports of child social functioning on standardized questionnaires
Measured: post-kindergarten (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)
Longitudinal parenting behaviors (parental involvement and positive parenting)
Caregiver and teacher reports on parental involvement in school as well as positive parenting practices
Measured: post-kindergarten (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMar 2013
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Social Learning Center
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, Katherine C. Pears, Oregon Social Learning Center
- Investigators
- Katherine C Pears, Ph.D., Principal investigator, Oregon Social Learning Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806987
- Sponsor's protocol ID
- R305A120391
- Other IDs
- R305A120391
- Acronym
- KITS-PN
- Status last verified
- Sep 2017
- First submitted
- 1 Mar 2013
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Pears 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 23710106Pears 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, Healey CV, Fisher PA, Braun D, Gill C, Conte HM, Newman J, Ticer S. Immediate Effects of a Program to Promote School Readiness in Low-Income Children: Results of a Pilot Study. Educ Treat Children. 2014 Aug;37(3):431-460. doi: 10.1353/etc.2014.0021.
PubMed 25382932Pears 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. Decreasing Risk Factors for Later Alcohol Use and Antisocial Behaviors in Children in Foster Care by Increasing Early Promotive Factors. Child Youth Serv Rev. 2016 May;65:156-165. doi: 10.1016/j.childyouth.2016.04.005.
PubMed 27158175
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
- A Randomized Efficacy Trial of the Kids in Transition to School (KITS) Program to Improve School Readiness of Children in Disadvantaged Communities
- ClinicalTrials.gov ID
- NCT01806987
- Acronym / sponsor ID
- KITS-PN / R305A120391
- Conditions
- School Readiness
- Keywords
- school readiness, literacy, social emotional skills, self regulation, caregiver involvement, socioeconomic disadvantage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Oregon Social Learning CenterUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Mar 2013
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 8 Mar 2013 (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 purpose of this project to determine whether the KITS Program, an intervention to improve early literacy, prosocial and emotion and behavior regulation domains of school readiness, improves school readiness and school outcomes in children from socioeconomically disadvantaged neighborhoods.
Detailed description
PURPOSE: This project is a randomized efficacy trial of the KITS Program, an intervention to improve early literacy, prosocial and emotion and behavior regulation domains of school readiness, with children from socioeconomically disadvantaged neighborhoods. The project will extend the evidence on the efficacy of the intervention from two previous randomized efficacy trials of the KITS Program with special needs populations to examine the impacts of the intervention on the broader population of children from disadvantaged backgrounds in general education.
SETTING: The intervention will be conducted in elementary school classrooms in high-poverty, high-crime neighborhoods in a medium-sized metropolitan area of the Pacific Northwest during the summer before and the first 2 months of kindergarten.
POPULATION: This study involves the recruitment of 240 children who will be entering kindergarten in the fall and their families in three yearly cohorts (n = 80). The children will be recruited from neighborhoods that have been selected as some of the most disadvantaged in the state in terms of income and school readiness indicators.
INTERVENTION: The KITS Program is a high-intensity, short-term program timed to occur during the transition to kindergarten-a critical developmental milestone with far-reaching effects on school outcomes. The curriculum focuses on the early literacy, social, and self-regulation skills critical for success in kindergarten and on contextual characteristics (i.e., parent involvement in early literacy and positive parenting). KITS features 24 curriculum-based therapeutic playgroups focused on early literacy, social, and self-regulatory skills and 12 psychoeducational parent workshops focused on parent involvement in early literacy and positive parenting practices.
CONTROL CONDITION: The children in the services-as-usual condition will receive any early childhood learning services that they would typically receive prior to school entry. Services received will be assessed at each data time point.
RESEARCH DESIGN AND METHODS: The children will be randomly assigned to the KITS condition or a services-as-usual condition and assessed at four time points: spring prior to kindergarten, immediately prior to kindergarten entry, kindergarten fall, and kindergarten spring; 160 of the children will also be assessed in first grade spring.
MEASURES AND KEY OUTCOMES: Our multimethod, multi-informant outcome measures will include the following: direct assessments of early literacy and social-emotional skills prior to kindergarten and literacy skills and social-emotional functioning during kindergarten and first grade; parent and teacher reports on child skills and behaviors, parent involvement in early literacy and school, and parenting practices; direct classroom observations of child academic engaged time and social behaviors; and school records data on grades, office discipline referrals, special education services received, and attendance.
DATA-ANALYTIC STRATEGIES: Analyses will employ variable-centered (e.g., ANOVA and regression) and person-centered (e.g., latent growth curve modeling) approaches. Multilevel latent variable modeling will be used to test how changes in hypothesized mediators affect longer-term outcomes and how outcomes vary depending on level of hypothesized moderators.
Study design
- Primary purpose
- Prevention
- 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 Program consists of: (a) child school readiness play groups to facilitate the development of self-regulatory, social, and early literacy skills (2 times per week in summer, 1 time per week in the fall); and (b) a 12 session psychoeducational workshop to promote parent involvement in the child's early literacy and schooling and the use of effective parenting techniques (once per week in summer, bi-weekly in the fall). |
| Services as usual | No intervention | –These include any services that the child and family might already be receiving in the community. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Child is entering kindergarten in a disadvantaged neighborhood
- Child is a bilingual or monolingual English speaker
Key exclusion criteria (1 listed)
- Child has a hearing or vision impairment that would limit participation in the intervention activities or assessment protocol
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 ProgramThe KITS Program is a 4-month psychosocial intervention for children at high risk for school difficulties and their caregivers. The intervention begins in the summer before kindergarten and continues across the first two months of kindergarten. The KITS intervention consists of: (a) child school readiness play groups to facilitate the development of self-regulatory, social, and early literacy skills (2 times per week in summer, 1 time per week in the fall); and (b) a 12 session psychoeducational workshop to promote parent involvement in the child's early literacy and schooling and the use of effective parenting techniques (once per week in summer, bi-weekly in the fall). | Behavioural | KITS Program |
Primary outcome
Change in early literacy skills from baseline to kindergarten fall
Time frame: pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
Standardized measures of early literacy skills including letter naming, phonological awareness and understanding of concepts about print
Change in prosocial skills from baseline to kindergarten fall
Time frame: pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
Standardized direct assessments of the child's responses to social situations as well as parent and teacher responses to standardized questionnaires on children's social skills
Change in emotion and behavior regulation skills from baseline to kindergarten fall
Time frame: pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
Standardized direct assessment of the children's executive function skills as well as parent and teacher report on standardized questionnaires used to assess emotion and behavior regulation
Change in parenting behavior (parent involvement and positive parenting practices) from baseline to kindergarten fall
Time frame: pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)
Caregiver reported involvement in early literacy activities and beliefs about the importance of various literacy skills for kindergarten as well as parenting practices
3 secondary outcomes
Longitudinal academic achievement across grade levels
Time frame: post-kindergarten (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)
Longitudinal social competence across grade levels
Time frame: post-kindergarten (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)
Longitudinal parenting behaviors (parental involvement and positive parenting)
Time frame: post-kindergarten (average of 12 months post-baseline), post-first grade (average of 24 months post-baseline)
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 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.
- 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 25382932Pears KC, Healey CV, Fisher PA, Braun D, Gill C, Conte HM, Newman J, Ticer S. Immediate Effects of a Program to Promote School Readiness in Low-Income Children: Results of a Pilot Study. Educ Treat Children. 2014 Aug;37(3):431-460. doi: 10.1353/etc.2014.0021.
- Results publication: 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.
- Results publication: PubMed 27158175Pears KC, Kim HK, Fisher PA. Decreasing Risk Factors for Later Alcohol Use and Antisocial Behaviors in Children in Foster Care by Increasing Early Promotive Factors. Child Youth Serv Rev. 2016 May;65:156-165. doi: 10.1016/j.childyouth.2016.04.005.
- Related InfoLink 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, Ph.D. 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 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 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?
Change in early literacy skills from baseline to kindergarten fall (time frame: pre-intervention (baseline), pre-kindergarten (average of 2-3 months post baseline), kindergarten fall (average of 4-5 months post-baseline)). 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 NCT01806987, which also lists 5 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.