CompletedNot Applicable

Behavioral Sleep Intervention in Urban Primary Care: Aim 3

United States103 participantsStarted 2020-10-16

Plain-language summary

Investigators will enroll up to 120 parent-child dyads from Children's Hospital of Philadelphia (CHOP) urban primary care clinics. The primary objective of this randomized clinical trial is to determine the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. The investigators will also examine the direction and magnitude in any change in child sleep and child behavior.

Who can participate

Age range1 Year – 5 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Parental/guardian permission (informed consent)
✓. Caregiver participant is the parent or legal guardian of the child subject
✓. Caregiver/legal guardian is greater than or equal to 18 years of age.
✓. Child between the ages of 1 and 5 years.
✓. Presence of caregiver-reported child sleep problem determined by a Brief Child Sleep Questionnaire item included in an eligibility screening questionnaire or child meets American Academy of Sleep Medicine diagnostic criteria for either pediatric insomnia or insufficient sleep, assessed through an eligibility screening questionnaire.
✓. English-speaking.

Exclusion criteria

✕. Caregiver is not parent or legal guardian of child participant.
✕. Presence of a child neurodevelopmental (e.g., autism spectrum disorder; Trisomy 21) or chronic medical (e.g., sickle cell disease, cancer) concern in which the disorder or treatment of the disorder impact sleep.
✕. Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

What they're measuring

Retention Rate (Intervention Feasibility)

Timeframe: Study duration (up to 24 weeks)

Family Engagement (Sessions)

Timeframe: Study duration (up to 24 weeks)

Family Engagement (Telephone Calls)

Timeframe: Study duration (up to 24 weeks)

Treatment Acceptability

Timeframe: Time 2 (an average of 9 weeks post-baseline)

Treatment Acceptability: Cultural Humility

Timeframe: Time 2 (an average of 9 weeks post-baseline)

Assessment Process (Study Feasibility)

Timeframe: Study duration (up to 24 weeks)

Trial details

NCT IDNCT04473222

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-31

Results submitted2024-07-03

View on ClinicalTrials.gov More Sleep Disturbance trials

Plain-language summary

Who can participate

Age range1 Year – 5 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Parental/guardian permission (informed consent)
✓. Caregiver participant is the parent or legal guardian of the child subject
✓. Caregiver/legal guardian is greater than or equal to 18 years of age.
✓. Child between the ages of 1 and 5 years.
✓. Presence of caregiver-reported child sleep problem determined by a Brief Child Sleep Questionnaire item included in an eligibility screening questionnaire or child meets American Academy of Sleep Medicine diagnostic criteria for either pediatric insomnia or insufficient sleep, assessed through an eligibility screening questionnaire.
✓. English-speaking.

Exclusion criteria

✕. Caregiver is not parent or legal guardian of child participant.
✕. Presence of a child neurodevelopmental (e.g., autism spectrum disorder; Trisomy 21) or chronic medical (e.g., sickle cell disease, cancer) concern in which the disorder or treatment of the disorder impact sleep.
✕. Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

What they're measuring

Retention Rate (Intervention Feasibility)

Timeframe: Study duration (up to 24 weeks)

Family Engagement (Sessions)

Timeframe: Study duration (up to 24 weeks)

Family Engagement (Telephone Calls)

Timeframe: Study duration (up to 24 weeks)

Treatment Acceptability

Timeframe: Time 2 (an average of 9 weeks post-baseline)

Treatment Acceptability: Cultural Humility

Timeframe: Time 2 (an average of 9 weeks post-baseline)

Assessment Process (Study Feasibility)

Timeframe: Study duration (up to 24 weeks)