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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Power PATH, Head Start as Usual
- 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 group | Role | What they receive |
|---|---|---|
| Power PATH | Experimental | 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) Receives: Behavioral: Power PATH |
| Head Start as usual | Active comparator | Head 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.
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)
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.
- First posted27 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Power PATHStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ansley Gilpin, Ph.D., Principal investigator, University of Alabama at Birmingham
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Family Well-Being and Child School Readiness: Power PATH Dual Generation Intervention With Head Start Preschoolers and Their Parents
- ClinicalTrials.gov ID
- NCT02176590
- Acronym / sponsor ID
- 90YR0075
- Conditions
- Power PATH, Head Start as Usual
- Keywords
- PATHS Social Emotional Learning, Coping Power, Power PATH, Head Start
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Jun 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Power PATH | Experimental | Behavioral: Power PATHClassroom 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) |
| Head Start as usual | Active comparator | Other: Head Start as usualHead Start as usual (will measure the effects of Head Start programming as usual on the primary outcomes) |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 4 year old preschool students in participating Head Start centers/classrooms in West Central Alabama, and their parents and teachers
Key exclusion criteria (1 listed)
- Severe developmental delay (making the student unable to complete the primary study measures)
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 |
|---|---|---|
| Power PATHAlso: Promoting Alternative Thinking Strategies (PATHS) Preschool/Kindergarten Social Emotional Learning Classroom Curriculum, Coping Power parent programPATHS: Teacher-led classroom curriculum promoting a positive classroom environment and teaching social-emotional skills | Behavioural | Power PATH |
| Head Start as usualStandard Head Start programming (including classroom instruction, meals, and family services) | Other | Head Start as usual |
Primary outcome
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.
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
Related trials for Power PATH
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Palliative Care, Generative Artificial Intelligence
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.
Ansley Gilpin, Ph.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
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.