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Power PATHPhase 2NCT02176590

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

A Phase 2 study testing Power PATH and Head Start as usual in people with Power PATH and Head Start as Usual, run by University of Alabama, Tuscaloosa at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 3 to 8 years
Conditions the study is for
Power PATH, Head Start as Usual
What is being tested?
Power PATH and Head Start as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
1 siteUnited States
Study dates
Aug 2014to Sep 2018
Phase
Phase 2
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 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Alabama

    Tuscaloosa, Alabama, 35487

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Power PATH, Head Start as usual
Keywords
PATHS Social Emotional Learning, Coping Power, Power PATH, Head Start

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Power PATHBehavioural

    Also called Promoting Alternative Thinking Strategies (PATHS) Preschool/Kindergarten Social Emotional Learning Classroom Curriculum, Coping Power parent program

    PATHS: Teacher-led classroom curriculum promoting a positive classroom environment and teaching social-emotional skills

  • Head Start as usualOther

    Standard Head Start programming (including classroom instruction, meals, and family services)

Study groups in NCT02176590
Study groupRoleWhat they receive
Power PATHExperimentalClassroom 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)
Receives: Behavioral: Power PATH
Head Start as usualActive comparatorHead Start as usual (will measure the effects of Head Start programming as usual on the primary outcomes)
Receives: Other: Head Start as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Child School Readiness

    Indicators of child school readiness (Behavior, Executive Functioning, Emotional Regulation, Pre-Reading skills) will be assessed at the end of preschool.

    Measured: One year (repeated through 1st grade)

  2. Family Well-being

    Indicators of Family Well-Being will be measured at the end of preschool (Parental stress, parenting, parental depression, economic and financial security, family environment)

    Measured: One Year (repeated through 1st grade)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionSep 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02176590
Sponsor's protocol ID
90YR0075
Status last verified
Nov 2015
First submitted
25 Jun 2014
Last updated
2 Dec 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Power PATH and Head Start as usual in people with Power PATH and Head Start as Usual, run by University of Alabama, Tuscaloosa 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Dec 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Child School Readiness (time frame: One year (repeated through 1st grade)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Dec 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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