Improving Family Well-Being and Child School Readiness: Power PATH Dual Generation Intervention

November 30, 2015 updated by: University of Alabama, Tuscaloosa

Improving Family Well-Being and Child School Readiness: Power PATH Dual Generation Intervention With Head Start Preschoolers and Their Parents

This project will test the proximal and distal effects of an integrated dual-generation intervention, Power PATH, in Head Start preschoolers and their parents in Alabama.

Study Overview

Status

Status

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

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.

Detailed Description

This project will test the proximal and distal effects of an integrated dual-generation intervention approach, Power PATH, in an existing Head Start University Partnership in Alabama. Dual generation approaches recognize the need to intervene with both parents and children in Head Start preschools, in order to improve parents' ability to provide safe and supportive caregiving environments and to prepare children for the transition to elementary school academically and behaviorally. Parents of Head Start preschoolers often have high levels of poverty, stress, and mental health needs (Yoshikowa, Aber, & Beardslee, 2012) and their children are at-risk for academic, behavioral, and social-emotional difficulties (Aber, Jones, & Cohen, 2000; Costello, Keeler, & Angold, 2001; Morales & Guerra, 2006). Thus, in this project, two evidence-based and widely-utilized preventive interventions will be adapted and thoughtfully integrated, in collabo-ration with Head Start personnel, to provide intensive, high quality services to Head Start parents and children. First, the Power PATH Parent Intervention program, adapted from Coping Power (Wells, Lochman & Lenhart, 2008) for this dual-generation approach, will be implemented to address parental mental health needs, to increase parental employment and financial security, and to improve parents' ability to model effective social-emotional skills. The parent intervention will help parents create a positive and predictable home environment, and support their child's academic learning and emotional and behavioral self-regulation. Second, the Promoting Alterna-tive Thinking Strategies (PATHS) Preschool Social and Emotional Learning curriculum (Domitrovich et al., 1999) will be implemented in the preschool classrooms. PATHS is a universal, classroom-based curriculum that increases children's social-emotional competence and self-regulatory skills, leading to long-term social, behavioral and academic gains. The Power PATH program will incorporate both of these parent and child interventions, and will include opportuni-ties for the children to teach their parents the social and emotional skills they are learning in the classroom, to promote skill- generalization and transfer to the home environment. This study will also identify novel intervention mediators and moderators, essential for interrupting the intergen-erational transmission of chronic social stress, and will identify the best interventions for families, particularly during preschool when self-regulation skills are still malleable, and children's primary environments and physiological responses to stress are likely to moderate intervention effects (Bierman et al., 2008; Boyce & Ellis, 2005; Porges, 2007). In summary, addressing sources of chronic stress in the parents of Head Start preschoolers (i.e., employment and financial insecurity, mental health needs, and family stressors) through the Power PATH dual generation intervention is expected to prepare parents to better support, shape and model their children's self-regulation skills and to better foster their children's school readiness, and to improve overall family well-being.

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 (Anticipated)

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.
540

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.
  • Phase 2

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
    • Alabama
      • Tuscaloosa, Alabama, United States, 35487
        • University of Alabama

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 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 4 year old preschool students in participating Head Start centers/classrooms in West Central Alabama, and their parents and teachers

Exclusion Criteria:

  • Severe developmental delay (making the student unable to complete the primary study measures)

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Experimental: Power PATH
Classroom PATHS Social Emotional Learning Curriculum (for preschool classrooms) plus Coping Power parent intervention (teaches parents what children are learning in the classroom PATHS program and also provides parents with mental health intervention and parenting topics to promote family well-being)
Behavioral: Power PATH
PATHS: Teacher-led classroom curriculum promoting a positive classroom environment and teaching social-emotional skills
Other Names:
  • Promoting Alternative Thinking Strategies (PATHS) Preschool/Kindergarten Social Emotional Learning Classroom Curriculum
  • Coping Power parent program
Active Comparator: Head Start as usual
Head Start as usual (will measure the effects of Head Start programming as usual on the primary outcomes)
Other: Head Start as usual
Standard Head Start programming (including classroom instruction, meals, and family services)

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
Child School Readiness
Time Frame: One year (repeated through 1st grade)
Indicators of child school readiness (Behavior, Executive Functioning, Emotional Regulation, Pre-Reading skills) will be assessed at the end of preschool.
One year (repeated through 1st grade)
Family Well-being
Time Frame: One Year (repeated through 1st grade)
Indicators of Family Well-Being will be measured at the end of preschool (Parental stress, parenting, parental depression, economic and financial security, family environment)
One Year (repeated through 1st grade)

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.
University of Alabama, Tuscaloosa

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: Ansley Gilpin, Ph.D., University of Alabama at Birmingham

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.
August 1, 2014

Primary Completion (Anticipated)

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.
September 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

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).
June 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.
June 25, 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.
June 27, 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.
December 2, 2015

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.
November 30, 2015

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.
November 1, 2015

More Information

Terms related to this study

Keywords

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.
  • 90YR0075

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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