Parent Intervention to Improve Child Sleep

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators pilot tested a parenting intervention to improve young children's sleep in families with low income. Families were randomized to an intervention or wait-list control group. The investigators hypothesized the intervention would be feasible and acceptable to enrolled families.

Detailed Description
-----------------
This pilot study tested a parenting intervention to improve young children's sleep in families with low income using a randomized controlled trial (RCT) design. Parents were randomized to the intervention or wait-list control group. Intervention content was delivered in virtual sessions with a parent and interventionist. The primary aim was to examine intervention feasibility (e.g., recruitment, retention, acceptability) with a secondary goal of preliminary efficacy on intervention changes in child sleep patterns to inform a future large-scale RCT. Exploratory evidence was collected on changes in children's health behaviors (e.g., diet, screen time), and social-emotional health (e.g., behavior problems) as indicators for potential spillover effects on these domains.

Official Title
-----------------
Parenting Intervention to Improve Young Children's Sleep Among Families With Low Income

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Behavioral: Sleep Tight


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents or primary caregivers 18 years of age or older Have a child 2-4 years of age Child's 24-hour sleep duration does not meet established recommendations based on child age English speaking Annual household income <= 200% of the Federal Poverty Line or receive assistance benefits (e.g., SNAP, WIC) Computer or phone access for video calls Exclusion Criteria: Parent or child has a medical condition that impairs their ability to participate Child has a clinical sleep disorder

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 4 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Intervention<br>The sleep intervention focuses on enhancing young children's sleep by providing parents with behavioral strategies and support. Interventionists will work with parents on establishing consistent soothing bedtime routines; behavioral regulation to manage bedtime resistance and nighttime wakings; goal setting, problem solving, and action planning; self-monitoring via daily sleep logs; and stimulus control of child's sleep environment. | Behavioral: Sleep Tight<br>* The sleep intervention focuses on enhancing young children's sleep by providing parents with behavioral strategies and support. Interventionists will work with parents on establishing consistent soothing bedtime routines; behavioral regulation to manage bedtime resistance and nighttime wakings; goal setting, problem solving, and action planning; self-monitoring via daily sleep logs; and stimulus control of child's sleep environment.<br>|
| No Intervention: Comparison/control<br>The comparison arm is a no-contact control group. Parents and children will not receive any intervention. They will be placed on a wait-list, and then offered the sleep intervention once the post-assessments are complete. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention feasibility: recruitment screening eligibility | Percent of children screened who were eligible | Through study completion, an average of 2 years | 
| Intervention feasibility: recruitment screening enrollment | Percent of children screened who were enrolled | Through study completion, an average of 2 years | 
| Intervention feasibility: recruitment duration | Duration to reach the target sample | Through study completion, an average of 2 years | 
| Intervention feasibility: Enrollment yield for each recruitment strategy | Percent of enrolled participants that were recruited via each recruitment strategy to determine the highest and lowest yielding strategies. | Through study completion, an average of 2 years | 
| Intervention feasibility: retention attendance | Percent attendance at assessment visits | Through study completion, an average of 2 years | 
| Intervention feasibility: retention percentage | Percent of sample retained at post-intervention | Through study completion, an average of 2 years | 
| Intervention feasibility: retention dropout | Percent of sample that drops out or is lost to follow-up | Through study completion, an average of 2 years | 
| Intervention feasibility: retention dropout reasons | Reasons for dropping out of the study | Through study completion, an average of 2 years | 
| Intervention acceptability | Acceptability will be assessed in an exit survey with Likert scale items and open-ended questions about intervention likes/dislikes and suggestions for future changes. Likert scale values range 1-5. Higher numbers indicate better outcomes (e.g., more positive acceptability) | Through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Process measures: Intervention attendance | Proportion of intervention sessions attended, including makeup sessions, obtained from attendance records. | Through study completion, an average of 2 years | 
| Process measures: Dose | Survey checklist completed by interventionists after each intervention session that rates the extent to which the program content was addressed | Through study completion, an average of 2 years | 
| Process measure: Implementation | Survey checklist completed by interventionists after each intervention session that assess implementation barriers | Through study completion, an average of 2 years | 
| Process measure: Engagement | Survey checklist completed by interventionists after each intervention session that assess perceived participant engagement | Through study completion, an average of 2 years | 
| Process measure: Content | Survey checklist completed by interventionists after each intervention session that assess perceived appropriateness of session content | Through study completion, an average of 2 years | 
| Child sleep: night sleep duration | Wrist-worn actigraphy devices were used to calculate child's nighttime sleep duration | Baseline (0 weeks) and post-intervention (8 weeks) | 
| Child sleep: daytime sleep duration | Wrist-worn actigraphy devices were used to calculate child's daytime sleep duration | Baseline (0 weeks) and post-intervention (8 weeks) | 
| Child sleep: 24-hour sleep duration | Wrist-worn actigraphy devices were used to calculate child's 24-hour sleep duration | Baseline (0 weeks) and post-intervention (8 weeks) | 
| Child sleep: sleep quality | Wrist-worn actigraphy devices were used to calculate child's sleep quality (e.g., wake after sleep onset) | Baseline (0 weeks) and post-intervention (8 weeks) | 
| Child sleep: sleep timing | Wrist-worn actigraphy devices were used to calculate variability in child's sleep timing | Baseline (0 weeks) and post-intervention (8 weeks) |