- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02176590
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
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
540
Phase
- 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
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Alabama
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Tuscaloosa, Alabama, United States, 35487
- University of Alabama
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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
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 |
Intervention / Treatment |
|---|---|
|
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)
|
PATHS: Teacher-led classroom curriculum promoting a positive classroom environment and teaching social-emotional skills
Other Names:
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Active Comparator: Head Start as usual
Head Start as usual (will measure the effects of Head Start programming as usual on the primary outcomes)
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Standard Head Start programming (including classroom instruction, meals, and family services)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child School Readiness
Time Frame: One year (repeated through 1st grade)
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Indicators of child school readiness (Behavior, Executive Functioning, Emotional Regulation, Pre-Reading skills) will be assessed at the end of preschool.
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One year (repeated through 1st grade)
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Family Well-being
Time Frame: One Year (repeated through 1st grade)
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Indicators of Family Well-Being will be measured at the end of preschool (Parental stress, parenting, parental depression, economic and financial security, family environment)
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One Year (repeated through 1st grade)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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
August 1, 2014
Primary Completion (Anticipated)
September 1, 2018
Study Completion (Anticipated)
September 1, 2018
Study Registration Dates
First Submitted
June 25, 2014
First Submitted That Met QC Criteria
June 25, 2014
First Posted (Estimate)
June 27, 2014
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
November 30, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Other Study ID 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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