AnxietyNCT06002360
Reach Out and Read (ROR) in the Neonatal Intensive Care Unit (NICU) Study
A study testing Reach Out and Read in people with Anxiety and Parent-Child Relations, run by University of Washington at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about the effects of the Reach Out and Read program on infants and their families in the neonatal ICU. The main goals of this study are: To complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores. Read more about this study
- Who is it for?
- Ages Up to 14 days
- Conditions the study is for
- Anxiety, Parent-Child Relations, Literacy
- What is being tested?
- Reach Out and Read
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to Jun 2024
- 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 Up to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Families of subjects born between 24w0d and 33w6d gestation
- Primary language is English or Spanish
Who cannot join
- Severe clinical instability such that the principal investigators do not think the infant will survive to 36 weeks gestation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington Medical Center NICU
Seattle, Washington, 98195
Devin McKissic, MD, devinam@uw.edu
About this study
Official title: The Effect of Reach Out and Read on Home Literacy Scores, Parental Stress, and Parent-Infant Bonding in the Neonatal ICU
The goal of this clinical trial is to learn about the effects of the Reach Out and Read program on infants and their families in the neonatal ICU. The main goals of this study are:
- To complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores.
- To evaluate the effects of the ROR intervention on parental stress levels as assessed by the 6-question State-Trait Anxiety Index (STAI-6)
- To evaluate the effects of the ROR intervention on parent-infant bonding by comparing scores on the 25-item Postpartum Bonding Questionnaire (PBQ)
- To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores
Read more
Participants will complete three questionnaires that include demographic information, home literacy scores, the Postpartum Bonding Questionnaire and the State-Trait Anxiety Index; once at study enrollment, once at 36 weeks corrected gestational age, and once at 3 months corrected gestational age.
Researchers will compare the control group (standard care) and a group that receives Reach Out and Read education to see whether exposure to Reach Out and Read affects literacy behaviors, parental anxiety, and parent-infant bonding.
- Conditions
- Anxiety, Parent-Child Relations, Literacy
- Being tested
- Reach Out and Read
- Medical subject headings
- Anxiety Disorders, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reach Out and ReadBehavioural
Families will be provided with a book and ROR programming from trained study team members (either the principal investigator or a research assistant, both of whom are ROR trained). ROR programming will include discussion of current reading practices, anticipatory guidance on the importance and benefits of reading, modeling of active reading, discussion of how to incorporate reading into a daily routine and answering any questions parents/caregivers may have.
| Study group | Role | What they receive |
|---|---|---|
| Reach Out and Read | Experimental | Families assigned to this group will receive Reach Out and Read education every two weeks between enrollment and when their infant reaches 36 weeks gestation. Receives: Behavioral: Reach Out and Read |
| Control | No intervention | Standard neonatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores
Measured: Between enrollment and 3 months corrected gestational age for infant
To evaluate the effects of the ROR intervention on parental stress levels as assessed by the 6-question State-Trait Anxiety Index (STAI-6)
Measured: Between enrollment and 3 months corrected gestational age for infant
To evaluate the effects of the ROR intervention on parent-infant bonding by comparing scores on the 25-item Postpartum Bonding Questionnaire (PBQ)
Measured: Between enrollment and 3 months corrected gestational age for infant
To complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Nov 2022
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Devin McKissic, University of Washington
- Investigators
- Devin McKissic, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002360
- Sponsor's protocol ID
- STUDY00015592
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reach Out and Read on Home Literacy Scores, Parental Stress, and Parent-Infant Bonding in the Neonatal ICU
- ClinicalTrials.gov ID
- NCT06002360
- Acronym / sponsor ID
- STUDY00015592
- Conditions
- Anxiety, Parent-Child Relations, Literacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 21 Aug 2023 (actual)
- 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 goal of this clinical trial is to learn about the effects of the Reach Out and Read program on infants and their families in the neonatal ICU. The main goals of this study are:
- To complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores.
- To evaluate the effects of the ROR intervention on parental stress levels as assessed by the 6-question State-Trait Anxiety Index (STAI-6)
- To evaluate the effects of the ROR intervention on parent-infant bonding by comparing scores on the 25-item Postpartum Bonding Questionnaire (PBQ)
- To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores
Participants will complete three questionnaires that include demographic information, home literacy scores, the Postpartum Bonding Questionnaire and the State-Trait Anxiety Index; once at study enrollment, once at 36 weeks corrected gestational age, and once at 3 months corrected gestational age.
Researchers will compare the control group (standard care) and a group that receives Reach Out and Read education to see whether exposure to Reach Out and Read affects literacy behaviors, parental anxiety, and parent-infant bonding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reach Out and Read | Experimental | Behavioral: Reach Out and ReadFamilies assigned to this group will receive Reach Out and Read education every two weeks between enrollment and when their infant reaches 36 weeks gestation. |
| Control | No intervention | –Standard neonatal care |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Families of subjects born between 24w0d and 33w6d gestation
- Primary language is English or Spanish
Key exclusion criteria (1 listed)
- Severe clinical instability such that the principal investigators do not think the infant will survive to 36 weeks gestation
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 |
|---|---|---|
| Reach Out and ReadFamilies will be provided with a book and ROR programming from trained study team members (either the principal investigator or a research assistant, both of whom are ROR trained). ROR programming will include discussion of current reading practices, anticipatory guidance on the importance and benefits of reading, modeling of active reading, discussion of how to incorporate reading into a daily routine and answering any questions parents/caregivers may have. | Behavioural | Reach Out and Read |
Primary outcome
To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores
Time frame: Between enrollment and 3 months corrected gestational age for infant
To evaluate the effects of the ROR intervention on parental stress levels as assessed by the 6-question State-Trait Anxiety Index (STAI-6)
Time frame: Between enrollment and 3 months corrected gestational age for infant
To evaluate the effects of the ROR intervention on parent-infant bonding by comparing scores on the 25-item Postpartum Bonding Questionnaire (PBQ)
Time frame: Between enrollment and 3 months corrected gestational age for infant
To complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores.
Time frame: At enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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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.
Devin McKissic principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reach Out and Read in people with Anxiety and Parent-Child Relations, run by University of Washington 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Devin McKissic ((206) 300-1239, devinam@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores (time frame: Between enrollment and 3 months corrected gestational age for infant). The study lists 4 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 21 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.