School ReadinessNCT01593189
Efficacy Trial of the Kids in Transition to School (KITS) Program for Children With Developmental Disabilities and Behavioral Problems
A study testing KITS Program in people with School Readiness, run by Oregon Social Learning Center at 1 site in United States.
Trial summary
This study focuses on children entering kindergarten with co-occurring developmental disabilities and behavior problems, a population especially likely to have low levels of school readiness. Prior research has shown that children with developmental disabilities are at risk for academic difficulties. 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
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Mar 2013
- 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
- Received early childhood special education services
- Judged to have behavioral problems that would interfere with the transition to kindergarten
- Entering kindergarten in the fall of the year in which recruited into the study
Who cannot join
- Mono-lingual Spanish speaker
- Severe visual, hearing or physical impairment that would prevent the child from completing the assessment tasks or participating in the intervention
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 for Children With Developmental Disabilities and Behavioral Problems
This study focuses on children entering kindergarten with co-occurring developmental disabilities and behavior problems, a population especially likely to have low levels of school readiness. Prior research has shown that children with developmental disabilities are at risk for academic difficulties. Behavioral and social problems are likely to interfere with school adjustment. The investigators hypothesize that children who receive the intervention will show better school readiness and school adjustment outcomes.
Read the detailed description
Purpose: This project is a randomized efficacy trial of KITS, an intervention to enhance social-emotional and early literacy domains of school readiness in children with co-occurring developmental disabilities and behavior problems who are entering kindergarten.
Setting: The setting for the intervention will be playgroups and parent support groups conducted in center-based classrooms during the summer before and the first 2 months of kindergarten.
Population: This study involves the recruitment of 200 children with co-occurring developmental disabilities and behavioral problems who are entering kindergarten in the fall (four yearly cohorts of 50 children each). The children will be recruited from the Lane County, Oregon, public agency responsible for early childhood special education services.
Intervention: KITS is a short-term, intensive program timed to occur during the transition to kindergarten-a critical developmental milestone with far-reaching effects on school outcomes. The KITS curriculum focuses on the social-emotional and early literacy skills shown to be essential for success in kindergarten and on contextual characteristics (i.e., parent involvement in early literacy and positive parenting) to support and promote these skills. KITS features 24 curriculum-based school readiness playgroups to facilitate the development of self-regulatory, social, and early literacy skills (twice weekly in the summer before kindergarten and once weekly September-October) and 7 psychoeducational parent groups focused on parent involvement in early literacy and positive parenting practices (every 2 weeks June-October).
Research Design and Methods: Children will be randomly assigned to the KITS intervention condition or a services-as-usual comparison group and assessed at four intervals: spring prior to kindergarten, immediately prior to kindergarten entry, kindergarten fall, and kindergarten spring. One hundred fifty of the children will also be assessed in the spring of first grade. KITS children will receive the intervention as described above.
Control condition: Children in the comparison group will receive any ECSE or other services that they would typically receive. These will be assessed at each data collection point.
Key measures: Multimethod, multiagent outcome measures will include the following: direct assessments of the child's social-emotional and early literacy skills prior to kindergarten and social-emotional functioning and literacy skills during kindergarten and first grade; parent and teacher reports on children's characteristics, parent involvement in early literacy and school, and parenting practices; and direct classroom observations of children's academic engaged time and social behaviors during unstructured school time.
Data-analytic strategies: Analyses will employ variable-based (e.g., ANOVA and regression) and person-based (e.g., latent growth curve modeling) approaches. SEM will be used to test how changes in hypothesized mediators affect outcomes and how outcomes vary depending on level of hypothesized moderators.
- Conditions
- School Readiness
- Being tested
- KITS Program
- Keywords
- developmental disabilities, school readiness, literacy, social emotional skills, self regulation, caregiver involvement
- Medical subject headings
- Developmental Disabilities, 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 children with developmental disabilities and behavior problems who are entering kindergarten and their caregivers. The intervention begins in the summer before 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 times per week in the fall); and (b) a bi-monthly psychoeducational support group to promote parent involvement in the child's early literacy and schooling and the use of effective parenting techniques
| Study group | Role | What they receive |
|---|---|---|
| KITS Program | Experimental | 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 times per week in the fall); and (b) a bi-monthly psychoeducational support group to promote parent involvement in the child's early literacy and schooling and the use of effective parenting techniques Receives: Behavioral: KITS Program |
| Services as usual | No intervention | Families continued to receive any services that they had been receiving in the community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in caregiver involvement from baseline to kindergarten entry
Caregiver reported involvement in early literacy activities and beliefs about the importance of various literacy skills for kindergarten
Measured: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Change in early literacy skills from baseline to kindergarten entry
Standardized measures of early literacy skills including letter naming, phonological awareness and understanding of concepts about print
Measured: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Change in social skills from baseline to kindergarten entry
Standardized direct assessments of the child's responses to social situations as well as parent responses to standardized questionnaires on children's social skills
Measured: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Change in regulatory skills from baseline to kindergarten entry
Standardized direct assessment of the children's executive function skills as well as parent report on standardized questionnaires used to assess emotion and behavior regulation
Measured: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Secondary outcomes (2)
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 (approximately 1 year post-baseline), post 1st grade (approximately 2 years 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 (approximately 1 year post-baseline), post 1st grade (approximately 2 years 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 May 2012 (estimated)
- Study startApr 2008
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 209 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593189
- Sponsor's protocol ID
- R324A080026
- Status last verified
- Oct 2015
- First submitted
- 2 May 2012
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pears KC, Fisher PA, Heywood CV, Bronz KD. Promoting school readiness in foster children. In: Saracho ON, Spodek B, eds. Contemporary Perspectives on Social Learning in Early Childhood Education Greenwich, CT: Information Age Publishing; 2007:173-198.
Pears KC, Kim HK, Healey CV, Yoerger K, Fisher PA. Improving child self-regulation and parenting in families of pre-kindergarten children with developmental disabilities and behavioral difficulties. Prev Sci. 2015 Feb;16(2):222-32. doi: 10.1007/s11121-014-0482-2.
PubMed 24676874
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. 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 for Children With Developmental Disabilities and Behavioral Problems
- ClinicalTrials.gov ID
- NCT01593189
- Acronym / sponsor ID
- R324A080026
- Conditions
- School Readiness
- Keywords
- developmental disabilities, school readiness, literacy, social emotional skills, self regulation, caregiver involvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Oregon Social Learning CenterUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Apr 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 May 2012 (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.
This study focuses on children entering kindergarten with co-occurring developmental disabilities and behavior problems, a population especially likely to have low levels of school readiness. Prior research has shown that children with developmental disabilities are at risk for academic difficulties. Behavioral and social problems are likely to interfere with school adjustment. The investigators hypothesize that children who receive the intervention will show better school readiness and school adjustment outcomes.
Detailed description
Purpose: This project is a randomized efficacy trial of KITS, an intervention to enhance social-emotional and early literacy domains of school readiness in children with co-occurring developmental disabilities and behavior problems who are entering kindergarten.
Setting: The setting for the intervention will be playgroups and parent support groups conducted in center-based classrooms during the summer before and the first 2 months of kindergarten.
Population: This study involves the recruitment of 200 children with co-occurring developmental disabilities and behavioral problems who are entering kindergarten in the fall (four yearly cohorts of 50 children each). The children will be recruited from the Lane County, Oregon, public agency responsible for early childhood special education services.
Intervention: KITS is a short-term, intensive program timed to occur during the transition to kindergarten-a critical developmental milestone with far-reaching effects on school outcomes. The KITS curriculum focuses on the social-emotional and early literacy skills shown to be essential for success in kindergarten and on contextual characteristics (i.e., parent involvement in early literacy and positive parenting) to support and promote these skills. KITS features 24 curriculum-based school readiness playgroups to facilitate the development of self-regulatory, social, and early literacy skills (twice weekly in the summer before kindergarten and once weekly September-October) and 7 psychoeducational parent groups focused on parent involvement in early literacy and positive parenting practices (every 2 weeks June-October).
Research Design and Methods: Children will be randomly assigned to the KITS intervention condition or a services-as-usual comparison group and assessed at four intervals: spring prior to kindergarten, immediately prior to kindergarten entry, kindergarten fall, and kindergarten spring. One hundred fifty of the children will also be assessed in the spring of first grade. KITS children will receive the intervention as described above.
Control condition: Children in the comparison group will receive any ECSE or other services that they would typically receive. These will be assessed at each data collection point.
Key measures: Multimethod, multiagent outcome measures will include the following: direct assessments of the child's social-emotional and early literacy skills prior to kindergarten and social-emotional functioning and literacy skills during kindergarten and first grade; parent and teacher reports on children's characteristics, parent involvement in early literacy and school, and parenting practices; and direct classroom observations of children's academic engaged time and social behaviors during unstructured school time.
Data-analytic strategies: Analyses will employ variable-based (e.g., ANOVA and regression) and person-based (e.g., latent growth curve modeling) approaches. SEM will be used to test how changes in hypothesized mediators affect 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 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 times per week in the fall); and (b) a bi-monthly psychoeducational support group to promote parent involvement in the child's early literacy and schooling and the use of effective parenting techniques |
| Services as usual | No intervention | –Families continued to receive any services that they had been receiving in the community. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Received early childhood special education services
- Judged to have behavioral problems that would interfere with the transition to kindergarten
- Entering kindergarten in the fall of the year in which recruited into the study
Key exclusion criteria (2 listed)
- Mono-lingual Spanish speaker
- Severe visual, hearing or physical impairment that would prevent the child from completing the assessment tasks or participating in the intervention
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 children with developmental disabilities and behavior problems who are entering kindergarten and their caregivers. The intervention begins in the summer before 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 times per week in the fall); and (b) a bi-monthly psychoeducational support group to promote parent involvement in the child's early literacy and schooling and the use of effective parenting techniques | Behavioural | KITS Program |
Primary outcome
Change in caregiver involvement from baseline to kindergarten entry
Time frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Caregiver reported involvement in early literacy activities and beliefs about the importance of various literacy skills for kindergarten
Change in early literacy skills from baseline to kindergarten entry
Time frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Standardized measures of early literacy skills including letter naming, phonological awareness and understanding of concepts about print
Change in social skills from baseline to kindergarten entry
Time frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Standardized direct assessments of the child's responses to social situations as well as parent responses to standardized questionnaires on children's social skills
Change in regulatory skills from baseline to kindergarten entry
Time frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)
Standardized direct assessment of the children's executive function skills as well as parent report on standardized questionnaires used to assess emotion and behavior regulation
2 secondary outcomes
Longitudinal academic achievement across grade levels
Time frame: post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years post-baseline)
Longitudinal social competence across grade levels
Time frame: post-kindergarten (approximately 1 year post-baseline), post 1st grade (approximately 2 years 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 15 Oct 2015.
- BackgroundPears KC, Fisher PA, Heywood CV, Bronz KD. Promoting school readiness in foster children. In: Saracho ON, Spodek B, eds. Contemporary Perspectives on Social Learning in Early Childhood Education Greenwich, CT: Information Age Publishing; 2007:173-198.
- Background: PubMed 24676874Pears KC, Kim HK, Healey CV, Yoerger K, Fisher PA. Improving child self-regulation and parenting in families of pre-kindergarten children with developmental disabilities and behavioral difficulties. Prev Sci. 2015 Feb;16(2):222-32. doi: 10.1007/s11121-014-0482-2.
- Oregon Social Learning Center web siteLink 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.
The record lists no contact. Use the official record to reach the sponsor.
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 15 Oct 2015. 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 caregiver involvement from baseline to kindergarten entry (time frame: pre-intervention (baseline), pre-kindergarten ( approximately 2 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 NCT01593189, which also lists 2 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 15 Oct 2015.