Head Start Classroom-based Approaches and Resources for Emotion and Social Skill Promotion (Head Start CARES)

October 3, 2014 updated by: MDRC
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2670

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • MDRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
Control group
Experimental: Incredible Years
incredible years intervention
Behavioral: Incredible Years Teacher Training
Experimental: Preschool PATHS
Preschool PATHS (Promoting Alternative Thinking Strategies)
Behavioral: Preschool PATHS
Experimental: Tools of the Mind
Behavioral: Tools of the Mind

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Classroom Climate: Classroom Assessment Scoring System (CLASS)
Time Frame: 0 to 12 months
Class-level outcome
0 to 12 months
Teacher Practice: Adapted Teaching Style Rating Scale (TSRS)
Time Frame: 0 to 12 months
Class-level outcome
0 to 12 months
Executive Function: Head-to-Toes
Time Frame: 0 to 12 months
Child-level outcome
0 to 12 months
Executive Function: Pencil Tap
Time Frame: 0 to 12 months
Child-level outcome
0 to 12 months
Social Problem-Solving: Challenging Situations Task
Time Frame: 0 to 12 months
Child-level outocme
0 to 12 months
Emotion Knowledge: Emotion Situations and Identification Tasks
Time Frame: 0 to 12 months
Child-level outcome
0 to 12 months
Pre-Academic Skills: Academic Rating Scale
Time Frame: 0 to 12 months
Child-level Outcome
0 to 12 months
Pre-Academic Skills: Expressive One-Word Picture Vocabulary Test
Time Frame: 0 to 12 months
Child-level outcome
0 to 12 months
Pre-Academic Skills: Woodcock-Johnson III
Time Frame: 0 to 12 months
Child-level outcome
0 to 12 months
Behavior Regulation: Behavior Problems Index
Time Frame: 0 to 12 months
Child-level outcome
0 to 12 months
Social Behaviors: Social Social Skills Rating Scale
Time Frame: 0 to 12 months
Child-level outcome
0 to 12 months
Social Behaviors: Cooper-Farran Behavioral Rating Scale- Interpersonal Skills
Time Frame: 0 to 12 months
Child-level outcome
0 to 12 months
Learning Behaviors: Cooper-Farran Behavioral Rating Scale- Work-Related Skills
Time Frame: 0 to 12 months
Child-level outcome
0 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MDRC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pamela Morris, Ph.D., MDRC/New York University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HHSP23320072909YC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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