Teacher PracticeNCT02257814
Head Start Classroom-based Approaches and Resources for Emotion and Social Skill Promotion (Head Start CARES)
A study testing Incredible Years Teacher Training, Preschool PATHS and Tools of the Mind in people with Teacher Practice and Child Social-Emotional Development, run by MDRC at 1 site in United States.
Trial summary
The purpose of this study was to deepen the evidence base for interventions that support the social-emotional skills that underlie children's engagement and attention to learning tasks by schools (learning behaviors) and their social interactions with teachers and peers (social behaviors). Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Teacher Practice, Child Social-Emotional Development
- What is being tested?
- Incredible Years Teacher Training, Preschool PATHS and Tools of the Mind
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,670 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jun 2012
- 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 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Grantees had to have at least 4 centers with a similar racial/ethnic composition
- An equal number of classrooms with full-day or part-day programs
- And a similar mix of four-year-old-only and mixed-age (three-and four-year-old) classrooms.
- Children had to speak English and Spanish.
Who cannot join
- A grantee was excluded from the sample if it: only ran early Head Start programs
- Only served migrant children
- Was located in a U.S. territory
- Only or mostly provided family child care or home services
- Was more than 100 miles from a "primary airport,"
- Operated fewer than 4 centers with two classrooms each
Show all 9Show fewer
- Had been in operation for less than 2 years
- Was not in compliance with Head Start Standards
- They were already systematically implementing a social-emotional curriculum or participating in another evaluation study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to deepen the evidence base for interventions that support the social-emotional skills that underlie children's engagement and attention to learning tasks by schools (learning behaviors) and their social interactions with teachers and peers (social behaviors). The study tested three theoretically-distinct approaches to enhancing children's social-emotional development, along with a comprehensive coaching and training model, on a large scale within the Head Start system.
- Being tested
- Incredible Years Teacher Training, Preschool PATHS, Tools of the Mind
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incredible Years Teacher TrainingBehavioural
Preschool PATHSBehavioural
Tools of the MindBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Control group |
| Incredible Years | Experimental | incredible years intervention Receives: Behavioral: Incredible Years Teacher Training |
| Preschool PATHS | Experimental | Preschool PATHS (Promoting Alternative Thinking Strategies) Receives: Behavioral: Preschool PATHS |
| Tools of the Mind | Experimental | Tools of the Mind Receives: Behavioral: Tools of the Mind |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classroom Climate: Classroom Assessment Scoring System (CLASS)
Class-level outcome
Measured: 0 to 12 months
Teacher Practice: Adapted Teaching Style Rating Scale (TSRS)
Class-level outcome
Measured: 0 to 12 months
Executive Function: Head-to-Toes
Child-level outcome
Measured: 0 to 12 months
Executive Function: Pencil Tap
Child-level outcome
Measured: 0 to 12 months
Social Problem-Solving: Challenging Situations Task
Child-level outocme
Measured: 0 to 12 months
Emotion Knowledge: Emotion Situations and Identification Tasks
Child-level outcome
Measured: 0 to 12 months
Pre-Academic Skills: Academic Rating Scale
Child-level Outcome
Measured: 0 to 12 months
Pre-Academic Skills: Expressive One-Word Picture Vocabulary Test
Child-level outcome
Measured: 0 to 12 months
Pre-Academic Skills: Woodcock-Johnson III
Child-level outcome
Measured: 0 to 12 months
Behavior Regulation: Behavior Problems Index
Child-level outcome
Measured: 0 to 12 months
Social Behaviors: Social Social Skills Rating Scale
Child-level outcome
Measured: 0 to 12 months
Social Behaviors: Cooper-Farran Behavioral Rating Scale- Interpersonal Skills
Child-level outcome
Measured: 0 to 12 months
Learning Behaviors: Cooper-Farran Behavioral Rating Scale- Work-Related Skills
Child-level outcome
Measured: 0 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startApr 2009
- Primary completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Teacher PracticeStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,670 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDRC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Morris, Ph.D., Principal investigator, MDRC/New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257814
- Sponsor's protocol ID
- HHSP23320072909YC
- Status last verified
- Oct 2014
- First submitted
- 25 Mar 2014
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mattera, S, Lloyd, CM, Fishman, M, and Bangser, M. (2013). A First Look at the Head Start CARES Demonstration: Large-Scale Implementation of Programs to Improve Children's Social-Emotional Competence. OPRE Report 2013-47. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head Start Classroom-based Approaches and Resources for Emotion and Social Skill Promotion (Head Start CARES)
- ClinicalTrials.gov ID
- NCT02257814
- Acronym / sponsor ID
- HHSP23320072909YC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,670 participants (actual)
- Lead sponsor
- MDRCUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2012 (actual)
- First posted
- 6 Oct 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 purpose of this study was to deepen the evidence base for interventions that support the social-emotional skills that underlie children's engagement and attention to learning tasks by schools (learning behaviors) and their social interactions with teachers and peers (social behaviors). The study tested three theoretically-distinct approaches to enhancing children's social-emotional development, along with a comprehensive coaching and training model, on a large scale within the Head Start system.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Control group |
| Incredible Years | Experimental | Behavioral: Incredible Years Teacher Trainingincredible years intervention |
| Preschool PATHS | Experimental | Behavioral: Preschool PATHSPreschool PATHS (Promoting Alternative Thinking Strategies) |
| Tools of the Mind | Experimental | Behavioral: Tools of the MindTools of the Mind |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Grantees had to have at least 4 centers with a similar racial/ethnic composition
- An equal number of classrooms with full-day or part-day programs
- And a similar mix of four-year-old-only and mixed-age (three-and four-year-old) classrooms.
- Children had to speak English and Spanish.
Key exclusion criteria (9 listed)
- A grantee was excluded from the sample if it: only ran early Head Start programs
- Only served migrant children
- Was located in a U.S. territory
- Only or mostly provided family child care or home services
- Was more than 100 miles from a "primary airport,"
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 |
|---|---|---|
| Incredible Years Teacher Training | Behavioural | Incredible Years |
| Preschool PATHS | Behavioural | Preschool PATHS |
| Tools of the Mind | Behavioural | Tools of the Mind |
Primary outcome
Classroom Climate: Classroom Assessment Scoring System (CLASS)
Time frame: 0 to 12 months
Class-level outcome
Teacher Practice: Adapted Teaching Style Rating Scale (TSRS)
Time frame: 0 to 12 months
Class-level outcome
Executive Function: Head-to-Toes
Time frame: 0 to 12 months
Child-level outcome
Executive Function: Pencil Tap
Time frame: 0 to 12 months
Child-level outcome
Social Problem-Solving: Challenging Situations Task
Time frame: 0 to 12 months
Child-level outocme
Emotion Knowledge: Emotion Situations and Identification Tasks
Time frame: 0 to 12 months
Child-level outcome
Pre-Academic Skills: Academic Rating Scale
Time frame: 0 to 12 months
Child-level Outcome
Pre-Academic Skills: Expressive One-Word Picture Vocabulary Test
Time frame: 0 to 12 months
Child-level outcome
Pre-Academic Skills: Woodcock-Johnson III
Time frame: 0 to 12 months
Child-level outcome
Behavior Regulation: Behavior Problems Index
Time frame: 0 to 12 months
Child-level outcome
Social Behaviors: Social Social Skills Rating Scale
Time frame: 0 to 12 months
Child-level outcome
Social Behaviors: Cooper-Farran Behavioral Rating Scale- Interpersonal Skills
Time frame: 0 to 12 months
Child-level outcome
Learning Behaviors: Cooper-Farran Behavioral Rating Scale- Work-Related Skills
Time frame: 0 to 12 months
Child-level outcome
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 6 Oct 2014.
- Results publicationMattera, S, Lloyd, CM, Fishman, M, and Bangser, M. (2013). A First Look at the Head Start CARES Demonstration: Large-Scale Implementation of Programs to Improve Children's Social-Emotional Competence. OPRE Report 2013-47. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.
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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.
Pamela Morris, Ph.D. principal investigator
MDRC/New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incredible Years Teacher Training, Preschool PATHS and Tools of the Mind in people with Teacher Practice and Child Social-Emotional Development, run by MDRC 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 4 inclusion and 9 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 6 Oct 2014. 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?
Classroom Climate: Classroom Assessment Scoring System (CLASS) (time frame: 0 to 12 months). The study lists 13 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 NCT02257814, which also lists 1 linked publication.
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 6 Oct 2014.