Clinical trial NCT01754077: Thirty Million Words Project: A Feasibility Trial
Official title: Thirty Million Words Project: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parental Language Behaviors
Keywords: Language
Behavior change
Intervention
Home visiting
Child language development
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the proposed research is to evaluate the Thirty Million Words (TMW) Intervention through a randomized, controlled pilot study. The primary goal of the intervention is to enrich the early language learning environment of children from low-socioeconomic status (SES) backgrounds by targeting parent skills that relate to adult word input and conversational turn taking. The investigators hypothesize that receiving the TMW intervention will result in changes in parent behaviors.

Detailed description: The investigators propose to administer the TMW intervention to a small group of parents from low SES backgrounds in the Chicago area, assessing outcomes for caregivers at specific time intervals after administration. An audio environment recording device, the Language ENvironment Analysis recorder (LENA), will be used to gather information about the child's home language environment. The treatment group will receive feedback from some of these home audio recordings to motivate behavior change. A comparison between measurements from baseline recordings (without linguistic feedback given) and recordings during the intervention program (with linguistic feedback given) will be used to evaluate changes in caregiver linguistic behavior. In addition to the report information, parents will also be provided with strategies for enriching the child's language environment, including advice on book reading and narration. A control arm will receive a brief nutrition intervention and complete the same number of recordings as the treatment group. The control group will complete the same assessment schedule as the treatment group. Assessment data will aid in evaluating the effects of the TMW intervention.

This pilot work is a critical step in understanding the language environment provided by parents of low-SES, the effectiveness of objective feedback, and the potential for change and improvement in parental behavior. After establishing a baseline of parent-child communication levels, LENA recordings will be performed at regular intervals to provide essential feedback and motivation for parents to continually optimize the language environment they provide for their children.

Eligibility criteria: Inclusion Criteria:

* Low-SES: income proxies and education proxies

Exclusion Criteria:

* High-SES: income proxies and education proxies
* developmental delays
* medical conditions that affect child speech or hearing

Primary outcomes:
measure: Parental Behavior Change - Language ENvironment Analysis (LENA): Quantitative Behavior Change (16 LENA recordings)
timeFrame: Baseline (3 Recordings), 1 per week for 8 weeks (8 recordings), Week 14, Week 18, Week 22
measure: Child Behavior Change - LENA: Quantitative Linguistic Change (16 recordings)
timeFrame: Baseline (3 weeks pre-intervention), 1 per week for 8 weeks (8 recordings), Week 14, Week 18, Week 22
Secondary outcomes:
measure: STAR Reading
timeFrame: Approximately 3 weeks pre-intervention
measure: Center for Epidemiological Studies Depression Screen, short form (CESD-10)
timeFrame: Approximately 3 weeks pre-intervention program
measure: Parent Behavior Checklist (PBC)
timeFrame: Approximately 3 weeks pre-intervention; 1 week post-intervention, 4-months post-intervention
measure: Wechsler Abbreviated Scales of Intelligence (WASI)
timeFrame: Approximately 3 week pre-intervention; 1 week post-intervention; 4 months post-intervention
measure: Child Receptive One Word Picture Vocabulary Test (ROWPVT)
timeFrame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
measure: Child MacArthur Communicative Development Inventory Short Form (CDI)
timeFrame: Approximately 3 weeks pre-intervention program; 1 week post-intervention; 4 months post-intervention
measure: Achenbach Child Behavior Checklist (CBCL)
timeFrame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
measure: Bayley Child Development Screener
timeFrame: Approximately 3 weeks pre-intervention
measure: TMW Questionnaire
timeFrame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
measure: Parental Behavior Change - LENA and Video: Qualitative Changes
timeFrame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
measure: Child Expressive One Word Picture Vocabulary Test (EOWPVT)
timeFrame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
measure: Parent Working Memory Test (Sym-Span)
timeFrame: Approximately 3 weeks pre-intervention
measure: Knowledge of Infant Development Index (KIDI)
timeFrame: Approximately 3 weeks pre-intervention
measure: Theories of Intelligence (TOI)
timeFrame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
measure: Parent Stress Index (PSI) short form
timeFrame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
measure: Models of Developing Language
timeFrame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
measure: Demographics
timeFrame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
measure: LENA Developmental Snapshot
timeFrame: Approximately 3 weeks pre-intervention program; 1 week post-intervention program; 4 months post-intervention program
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Dana L Suskind, MD
role: PRINCIPAL_INVESTIGATOR
References: