NCT04163510

Brief Summary

Reading is a fundamental skill that is required for children's successful participation in school. Later in life, individuals who were unable to attain adequate reading levels during childhood face a cascade of deficits and social marginalization. By the end of third grade, predictions are already made about the probability of high school graduation, employability, dependence on welfare, incarceration, and decreased health outcomes. With 64% of fourth graders and 66% of eighth graders nationwide reading below grade level, illiteracy and low literacy constitute a silent epidemic that poses incredibly deleterious financial and human costs to individuals and to society. With low readers existing disproportionately in low-income communities, the children of low-income parents constitute a vulnerable sector of our society, at risk of poor literacy development and ultimately facing the above-mentioned disadvantages later in life. The purpose of this study is to empower low-income parents of elementary school children who are reading below grade level with strategies and tools to incorporate reading into their home routines; to inspire parents to approach reading with their children with an attitude of fun, positivity, and enthusiasm; to inculcate positive feelings towards reading among parents and children; and ultimately to increase the frequency of participants' home reading participation. The study will consist of a nine-week program including game playing, recipe following, neighborhood walks, trips to the library, and coaching on establishing reading resources and routines at home. Ten sets of parents will be recruited to participate in this study. Qualitative data will be extracted from field notes taken during intervention sessions and from parent interviews. It is anticipated that study results will provide information to occupational therapists to help parents better support their children's literacy development.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

November 12, 2019

Last Update Submit

August 13, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Family Reading Occupations Questionnaire

    The Family Reading Occupations Questionnaire is a 14-item, 5 minute questionnaire with 4 open-ended questions and 10 Likert scale questions. The scale ranges from scores of 10 to 50 with lower scores indicating better outcomes. The questionnaire allows parents to identify the type of reading activities they engage their children with and how frequently.

    week 10

  • Child Reading Occupations Questionnaire

    The Child Reading Occupations Questionnaire is an 8-item, 5 minute questionnaire that allows children to indicate what types of reading activities they enjoy. All questions are open-ended and provide descriptive narrative.

    week 10

Study Arms (1)

Reading Intervention Group

EXPERIMENTAL

A group of parents and their children will participate in this single arm, pre-/post-intervention study. This 10-week study will include 10 sets of parents of low-reading elementary school children, recruited from Harlem Grown Community Center. Intervention will be implemented in a 9-week period, with data collection during the first intervention week and one week post-intervention. Three large-group sessions will be held in a central location (at Harlem Grown Community Center), to build community and rapport among researchers and participants. Six individual sessions will take place in the participants' homes, to customize reading strategies and routines to each family's home setting and personal interests. The reading program will help parents identify strategies to establish literacy routines with their children, and to engage with them in enjoyable literacy activities that promote skill building while reducing negative feelings associated with reading.

Behavioral: Behavioral: Parent/Child Reading Program

Interventions

A 9-week parent/child reading program will help parents to identify strategies to establish literacy routines with their children, and to engage with them in enjoyable literacy activities that promote skill building while reducing negative feelings associated with reading. Three large-group sessions will be held in a central location, to build community and rapport among researchers and participants. Six individual sessions will take place in the participants' homes, to customize reading strategies and routines to each family's home setting and personal interests. Intervention sessions will be held once per week for 60-90 minute sessions.

Reading Intervention Group

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be parents and their children who are members of Harlem Grown Community Center.
  • Elementary school children, in grades 1-3, who are having difficulty with reading skills, as perceived by their parents.

You may not qualify if:

  • Parents who are unable to commit to a 10-week program that includes group sessions at Harlem Grown and individualized sessions in their homes will be excluded from study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Sharon Gutman, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: One group of 10 sets of parents and their children will participate. The study design will use pre-intervention and post-intervention measures.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 14, 2019

Study Start

February 1, 2021

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

August 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

No plan to make individual participant data available to other researchers.