Clinical trial NCT03431545: An Integrative Approach to Improve Child Outcomes Through Research-based Parent and Teacher Interventions
Official title: An Integrative Approach to Improve Child Outcomes Through Research-based Parent and Teacher Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth & Development
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 260
Sex: ALL
Minimum age (years): 5
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to learn whether a combination of two research-proven programs, a responsive caregiving parenting program and a teacher training program, will have an effect on infants' and toddlers' language, cognitive, social-emotional, and self-regulation skills. The interventions are designed to specifically target parent use of a responsive, stimulating caregiving style in the home in combination with teacher instructional practices and the use of a responsive interactive style in the classroom.


Eligibility criteria: Inclusion Criteria:

* Given that the target population includes EHS agencies, low-income children speaking English and/or Spanish will be eligible for participation.
* In some cases, children with mild delays (e.g., receiving speech therapy services) can participate.

Exclusion Criteria:

* Children with significant developmental disabilities (e.g., intellectual disabilities, significant sensory impairments, and children diagnosed with moderately severe forms of Autism Spectrum Disorders) will not be consented for assessments as the interventions are not specialized to meet the needs of these children.
* Children primarily speaking a language other than Spanish or English will be excluded due to the fact that appropriate assessment procedures are lacking.
* In terms of exclusionary criteria for teachers, those that are participating in other research studies, or who have recently completed other similar studies, will not be recruited.

Primary outcomes:
measure: Change in teacher behavior as assessed by the The Quality of Caregiver-Child Interactions for Infant and Toddlers (Q-CCIIT) Scale
timeFrame: baseline, 9 months
measure: Change in parent behavior as assessed by coding of videotaped parent-child interactions during toy play in the home
timeFrame: baseline, 9 months
measure: Change in parent behavior as assessed by coding of videotaped parent-child interactions during shared reading in the home
timeFrame: baseline, 9 months
measure: Change in child language as assessed by the Preschool Language Scale-Fifth Edition
timeFrame: baseline, 9 months
measure: Change in child language as assessed by the Early Communication Indicator
timeFrame: baseline, 9 months
measure: Change in child language as assessed by the MacArthur-Bates Communicative Development Inventories - Short Form (parent reported)
timeFrame: baseline, 9 months
measure: Change in child cognitive skills as assessed by the Bayley Scales of Development - III Screening Test
timeFrame: baseline, 9 months
measure: Change in child social-emotional behaviors as assessed by coding of videotaped parent-child interactions during toy play in the home.
timeFrame: baseline, 9 months
measure: Change in child social-emotional behaviors as assessed by coding of videotaped parent-child interactions during c in the home.
timeFrame: baseline, 9 months
measure: Change in child socio-emotional skills as assessed by the Brief Infant Toddler Social Emotional Assessment (parent reported)
timeFrame: baseline, 9 months
measure: Change in child self-regulation as assessed by a delay task
timeFrame: baseline, 9 months
measure: Change in child self-regulation as assessed by a slowing down motor task
timeFrame: baseline, 9 months
measure: Change in child self-regulation as assessed by a suppressing/initiating a response task
timeFrame: baseline, 9 months
Secondary outcomes:
measure: Change in teacher characteristics as assessed by the Center for Epidemiologic Studies Depression Scale - Revised
timeFrame: baseline, 9 months
measure: Change in teacher characteristics as assessed by the Parental Modernity Scale
timeFrame: baseline, 9 months
measure: Change in parent characteristics as assessed by the Center for Epidemiologic Studies Depression Scale - Revised
timeFrame: baseline, 9 months
measure: Change in parent characteristics as assessed by the Parental Modernity Scale
timeFrame: baseline, 9 months
measure: Change in parent characteristics as assessed by the Parenting Stress Index, Fourth Edition Short Form
timeFrame: baseline, 9 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Janelle J Montroy, PhD
role: PRINCIPAL_INVESTIGATOR
References: