Parental Language BehaviorsTMWNCT01754077
Thirty Million Words Project: A Feasibility Trial
A study testing LENA Linguistic Feedback Reports, Home Visiting Educational Session and Childhood Nutrition Education in people with Parental Language Behaviors, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Parental Language Behaviors
- What is being tested?
- LENA Linguistic Feedback Reports, Home Visiting Educational Session and Childhood Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2012
- Phase
- Interventional
- 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 17 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Low-SES: income proxies and education proxies
Who cannot join
- High-SES: income proxies and education proxies
- developmental delays
- medical conditions that affect child speech or hearing
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parental Language Behaviors
- Being tested
- LENA Linguistic Feedback Reports, Home Visiting Educational Session, Childhood Nutrition Education
- Keywords
- Language, Behavior change, Intervention, Home visiting, Child language development
- Medical subject headings
- Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LENA Linguistic Feedback ReportsBehavioural
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.
Home Visiting Educational SessionBehavioural
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.
Childhood Nutrition EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Thirty Million Words Project | Experimental | 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. Receives: Behavioral: LENA Linguistic Feedback Reports; Behavioral: Home Visiting Educational Session |
| Control Group | Other | 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. Receives: Behavioral: Childhood Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline (3 weeks pre-intervention), 1 per week for 8 weeks (8 recordings), Week 14, Week 18, Week 22
Secondary outcomes (18)
STAR Reading
Computerized assessment of parent reading level.
Measured: 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.
Measured: Approximately 3 weeks pre-intervention program
Parent Behavior Checklist (PBC)
Validated assessment concerning different types of parenting 'style'
Measured: Approximately 3 weeks pre-intervention; 1 week post-intervention, 4-months post-intervention
Wechsler Abbreviated Scales of Intelligence (WASI)
Parent IQ
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 3 weeks pre-intervention
TMW Questionnaire
Novel questionnaire developed for use in the study. Assessed parent level of knowledge concerning child language development.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Approximately 3 weeks pre-intervention
Knowledge of Infant Development Index (KIDI)
Questionnaire assessing parent knowledge of infant development
Measured: Approximately 3 weeks pre-intervention
Theories of Intelligence (TOI)
6 item questionnaire regarding incremental and entity theories of intelligence
Measured: 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
Measured: 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.
Measured: 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
Measured: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
LENA Developmental Snapshot
Parent report of child's language development level
Measured: Approximately 3 weeks pre-intervention program; 1 week post-intervention program; 4 months post-intervention program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parental Language BehaviorsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana L Suskind, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754077
- Sponsor's protocol ID
- 09-209-B
- Acronym
- TMW
- Status last verified
- Sep 2013
- First submitted
- 13 Dec 2012
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thirty Million Words Project: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT01754077
- Acronym / sponsor ID
- TMW / 09-209-B
- Conditions
- Parental Language Behaviors
- Keywords
- Language, Behavior change, Intervention, Home visiting, Child language development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Dec 2012 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thirty Million Words Project | Experimental | Behavioral: LENA Linguistic Feedback Reports, Behavioral: Home Visiting Educational SessionThe 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. |
| Control Group | Other | Behavioral: Childhood Nutrition EducationThe 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. |
Who may qualify
- Ages
- 17 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Low-SES: income proxies and education proxies
Key exclusion criteria (3 listed)
- High-SES: income proxies and education proxies
- developmental delays
- medical conditions that affect child speech or hearing
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 |
|---|---|---|
| LENA Linguistic Feedback ReportsLENA 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. | Behavioural | Thirty Million Words Project |
| Home Visiting Educational SessionA 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. | Behavioural | Thirty Million Words Project |
| Childhood Nutrition EducationThe 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. | Behavioural | Control Group |
Primary outcome
Parental Behavior Change - Language ENvironment Analysis (LENA): Quantitative Behavior Change (16 LENA recordings)
Time frame: Baseline (3 Recordings), 1 per week for 8 weeks (8 recordings), Week 14, Week 18, Week 22
The LENA provides data for the following categories of adult behaviors: Adult Word Count (AWC), Conversational Turn Count (CTC), and Television Time (TVT).
Child Behavior Change - LENA: Quantitative Linguistic Change (16 recordings)
Time frame: Baseline (3 weeks pre-intervention), 1 per week for 8 weeks (8 recordings), Week 14, Week 18, Week 22
LENA system provides information on Child Vocalization Count (CVC) and Conversational Turn Count (CTC) in the home environment.
18 secondary outcomes
STAR Reading
Time frame: Approximately 3 weeks pre-intervention
Center for Epidemiological Studies Depression Screen, short form (CESD-10)
Time frame: Approximately 3 weeks pre-intervention program
Parent Behavior Checklist (PBC)
Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention, 4-months post-intervention
Wechsler Abbreviated Scales of Intelligence (WASI)
Time frame: Approximately 3 week pre-intervention; 1 week post-intervention; 4 months post-intervention
Child Receptive One Word Picture Vocabulary Test (ROWPVT)
Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Child MacArthur Communicative Development Inventory Short Form (CDI)
Time frame: Approximately 3 weeks pre-intervention program; 1 week post-intervention; 4 months post-intervention
Achenbach Child Behavior Checklist (CBCL)
Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Bayley Child Development Screener
Time frame: Approximately 3 weeks pre-intervention
TMW Questionnaire
Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Parental Behavior Change - LENA and Video: Qualitative Changes
Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Child Expressive One Word Picture Vocabulary Test (EOWPVT)
Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Parent Working Memory Test (Sym-Span)
Time frame: Approximately 3 weeks pre-intervention
Knowledge of Infant Development Index (KIDI)
Time frame: Approximately 3 weeks pre-intervention
Theories of Intelligence (TOI)
Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Parent Stress Index (PSI) short form
Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Models of Developing Language
Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Demographics
Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
LENA Developmental Snapshot
Time frame: Approximately 3 weeks pre-intervention program; 1 week post-intervention program; 4 months post-intervention program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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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.
Dana L Suskind, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LENA Linguistic Feedback Reports, Home Visiting Educational Session and Childhood Nutrition Education in people with Parental Language Behaviors, run by University of Chicago 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 3 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: finished, as of the sponsor's last update on 5 Sep 2013. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Parental Behavior Change - Language ENvironment Analysis (LENA): Quantitative Behavior Change (16 LENA recordings) (time frame: Baseline (3 Recordings), 1 per week for 8 weeks (8 recordings), Week 14, Week 18, Week 22). 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 5 Sep 2013.