Thirty Million Words Project: A Feasibility Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Thirty Million Words Project: A Feasibility Trial

Conditions
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Parental Language Behaviors

Intervention / Treatment
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* Behavioral: LENA Linguistic Feedback Reports
* Behavioral: Home Visiting Educational Session
* Behavioral: Childhood Nutrition Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thirty Million Words Project<br>The participants in the intervention group receive the LENA linguistic feedback reports intervention and the home visiting educational session intervention. Participants in this arm complete the same assessments as participants in the control group. | Behavioral: LENA Linguistic Feedback Reports<br>* LENA feedback reports show hourly/daily estimates for AWC/CTC and TV/electronic media. The feedback reports will include data obtained from LENA home audio recordings that the families complete. Feedback reports are only given to parents for 8 weekly recordings. The parent does not receive a feedback report for the baseline recordings or the follow-up recordings.<br>Behavioral: Home Visiting Educational Session<br>* A research assistant visited the homes of the participants to discuss strategies, skills, and barriers related to enriching children's language environments. The visits included a multi-media educational module, video modeling exercise, goal setting, and linguistic feedback report review. There were 8 weekly home visits in the intervention program.<br>|
| Other: Control Group<br>The control group receives the Childhood Nutrition Education intervention. Participants in this group completed the same assessments as the treatment group. Following participation in the control group, eligible families were offered the opportunity to continue into the experimental group. | Behavioral: Childhood Nutrition Education<br>* The childhood nutrition education intervention is a brief home-visiting intervention during which parents receive information on nutrition from a research assistant. The intervention mirrored the experimental group's educational intervention and decreased the likelihood of differences between groups being the result of attentional effects. This intervention is received by the control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental Behavior Change - Language ENvironment Analysis (LENA): Quantitative Behavior Change (16 LENA recordings) | The LENA provides data for the following categories of adult behaviors: Adult Word Count (AWC), Conversational Turn Count (CTC), and Television Time (TVT). | Baseline (3 Recordings), 1 per week for 8 weeks (8 recordings), Week 14, Week 18, Week 22 | 
| Child Behavior Change - LENA: Quantitative Linguistic Change (16 recordings) | LENA system provides information on Child Vocalization Count (CVC) and Conversational Turn Count (CTC) in the home environment. | Baseline (3 weeks pre-intervention), 1 per week for 8 weeks (8 recordings), Week 14, Week 18, Week 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STAR Reading | Computerized assessment of parent reading level. | Approximately 3 weeks pre-intervention | 
| Center for Epidemiological Studies Depression Screen, short form (CESD-10) | Validated brief depression screen for parent. Appropriate referrals were made for parents who received a score above the CESD-10 cut score and who experienced suicidal ideation or self harm. | Approximately 3 weeks pre-intervention program | 
| Parent Behavior Checklist (PBC) | Validated assessment concerning different types of parenting 'style' | Approximately 3 weeks pre-intervention; 1 week post-intervention, 4-months post-intervention | 
| Wechsler Abbreviated Scales of Intelligence (WASI) | Parent IQ | Approximately 3 week pre-intervention; 1 week post-intervention; 4 months post-intervention | 
| Child Receptive One Word Picture Vocabulary Test (ROWPVT) | Interactive assessment of child's receptive vocabulary | Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention | 
| Child MacArthur Communicative Development Inventory Short Form (CDI) | Parent self-report of child expressive vocabulary. | Approximately 3 weeks pre-intervention program; 1 week post-intervention; 4 months post-intervention | 
| Achenbach Child Behavior Checklist (CBCL) | Parent reported assessment of child problematic behaviors. | Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention | 
| Bayley Child Development Screener | Short screener to assess child's level of development for five categories: cognitive, fine motor, gross motor, expressive, and receptive vocabulary. | Approximately 3 weeks pre-intervention | 
| TMW Questionnaire | Novel questionnaire developed for use in the study. Assessed parent level of knowledge concerning child language development. | Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention | 
| Parental Behavior Change - LENA and Video: Qualitative Changes | LENA transcription:Mean length utterance (MLU), type/token, syntactical complexity, gesture. Video: gesture, responsive parenting behaviors (e.g. being on child's level) | Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention | 
| Child Expressive One Word Picture Vocabulary Test (EOWPVT) | Interactive assessment that evaluates child's expressive vocabulary. | Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention | 
| Parent Working Memory Test (Sym-Span) | Computer administered assessment of parent working memory. | Approximately 3 weeks pre-intervention | 
| Knowledge of Infant Development Index (KIDI) | Questionnaire assessing parent knowledge of infant development | Approximately 3 weeks pre-intervention | 
| Theories of Intelligence (TOI) | 6 item questionnaire regarding incremental and entity theories of intelligence | Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention | 
| Parent Stress Index (PSI) short form | Parent self-report assessment of stress levels related to parenting | Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention | 
| Models of Developing Language | Parent self report evaluating parent's beliefs about language acquisition. | Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention | 
| Demographics | Questionnaire about family background information and the child's developmental history | Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention | 
| LENA Developmental Snapshot | Parent report of child's language development level | Approximately 3 weeks pre-intervention program; 1 week post-intervention program; 4 months post-intervention program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Language, Behavior change, Intervention, Home visiting, Child language development