Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT02176590 |
| Other study ID # |
90YR0075 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
Phase 2
|
| First received |
June 25, 2014 |
| Last updated |
November 30, 2015 |
| Start date |
August 2014 |
| Est. completion date |
September 2018 |
Study information
| Verified date |
November 2015 |
| Source |
University of Alabama, Tuscaloosa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical 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.
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.
