Infant Night Wakings in Pediatric Primary Care

NCT02780596 | Completed

• 2 other identifiers: 1506090982N109471
• Study Type: interventional
• Target: 3,501
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to:

1. 1.identify which single item or combination of two items perform best in identifying problematic infant night wakings and
2. 2.describe current practices by pediatricians in addressing problematic infant night wakings.

Conditions

Insomnia; Night Wakings

Keywords

Infant; Toddler; Primary Care

Outcome Measures

Primary Outcomes (1)

• Problematic infant night wakings (per validated questionnaire)

  Identifying the individual item or combination of two items that most strongly predict a positive score on the Infant Sleep Questionnaire

  On the day of each visit to the PCP for the duration of the study (18 months) or until patient no longer meets eligibility (e.g. ages out).

Secondary Outcomes (2)

• Problematic infant night wakings (per provider clinical judgment)

  On the day of each visit to the PCP for the duration of the study (18 months) or until patient no longer meets eligibility (e.g. ages out).

• Night wakings management (per caregiver report)

  Within two weeks after the visit to the primary care provider

Study Arms (8)

Items1;3

EXPERIMENTAL

Caregiver is randomly assigned to receive screening items 1 and 3. Item 1: Does CHILD NAME often wake one or more times during the night? Item 3: Do you think CHILD NAME's sleep is a problem?

Other: Item1; Other: Item3

Items1;4

EXPERIMENTAL

Caregiver is randomly assigned to receive screening items 1 and 4. Item 1: Does CHILD NAME often wake one or more times during the night? Item 4: Does you think CHILD NAME has a sleep problem?

Other: Item1; Other: Item4

Items1;5

EXPERIMENTAL

Caregiver is randomly assigned to receive screening items 1 and 5. Item 1: Does CHILD NAME often wake one or more times during the night? Item 5: Do you have any concerns about CHILD NAME's sleep?

Other: Item1; Other: Item5

Items2;3

EXPERIMENTAL

Caregiver is randomly assigned to receive screening items 2 and 3. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 3: Do you think CHILD NAME's sleep is a problem?

Other: Item2; Other: Item3

Items2;4

EXPERIMENTAL

Caregiver is randomly assigned to receive screening items 2 and 4. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 4: Does you think CHILD NAME has a sleep problem?

Other: Item2; Other: Item4

Items2;5

EXPERIMENTAL

Caregiver is randomly assigned to receive screening items 2 and 5. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 5: Do you have any concerns about CHILD NAME's sleep?

Other: Item2; Other: Item5

Items3;5

EXPERIMENTAL

Caregiver is randomly assigned to receive screening items 3 and 5. Item 3: Do you think CHILD NAME's sleep is a problem? Item 5: Do you have any concerns about CHILD NAME's sleep?

Other: Item3; Other: Item5

Items4;5

EXPERIMENTAL

Caregiver is randomly assigned to receive screening items 4 and 5. Item 4: Does you think CHILD NAME has a sleep problem? Item 5: Do you have any concerns about CHILD NAME's sleep?

Other: Item4; Other: Item5

Interventions

Item1 OTHER

Does CHILD NAME often wake one or more times during the night?

Items1;3; Items1;4; Items1;5

Item2 OTHER

Does CHILD NAME often wake one or more times per night, and does and adult go to him/her?

Items2;3; Items2;4; Items2;5

Item3 OTHER

Do you think CHILD'S SLEEP is a problem?

Items1;3; Items2;3; Items3;5

Item4 OTHER

Do you think CHILD NAME has a sleep problem?

Items1;4; Items2;4; Items4;5

Item5 OTHER

Do you have any concerns about CHILD NAME'S sleep?

Items1;5; Items2;5; Items3;5; Items4;5

Eligibility Criteria

• Age: 5 Months - 20 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant between the ages of 5 and 20 months (at the time of the visit)
• Caregiver responds to questions on the prescreening form in the waiting room
• Infant is a patient at one of five participating primary care health clinics in Indianapolis Indiana.
• For participation in the phone interviews, caregiver speaks English.

You may not qualify if:

• None

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Sarah M Honaker, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 23, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)