About this trial
The goal of this clinical trial is to learn whether Talk Parenting, a voice-based program delivered through an Amazon Echo Dot (Alexa), can help parents and caregivers of children ages 3-5 years improve challenging bedtime and morning routines. The main questions it aims to answer are:
Does using Talk Parenting improve families' bedtime and morning experiences and children's sleep/wake habits?
Does using Talk Parenting improve parents' routine-related parenting practices and confidence, strengthen the parent-child relationship, and reduce children's behavior problems and parents' stress?
Researchers will compare families who receive Talk Parenting right away to families who wait 6 weeks to receive the program (a waitlist control group receiving usual services during the wait).
Participants will:
Complete online questionnaires at the start of the study and again about 6 weeks later (and a follow-up questionnaire later in the study).
Receive a pre-configured Amazon Echo Dot (to keep) and instructions to use Talk Parenting routines at home, including a bedtime routine, a brief calming routine, and a morning routine (enabled after the first 2 weeks).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Referred by a participating agency
Child 3-5 years old who lives with the parent at least half time
The primary parent in the home (typically the mother but not always)
Speaks English
Disqualifiers
Families of target-age children with a developmental disability severe enough that the child cannot speak or follow simple directions will be excluded
Families of target-age children whose needs are beyond the scope of Talk Parenting will be excluded
Trial design
Parallel
Treatments tested in this trial
The Talk Parenting Program
BehavioralIn a 6-week session, families will use at home the Talk Parenting program, a smart speaker app designed to provide parents with in-situ experiential support for building positive family bedtime and morning routines. The Bedtime Routine, Morning Routine, and Calming Down Mini-Routine modules of Talk Parenting will guide families in creating healthy bedtime and morning routines to foster healthy sleep/wake habits, provide experiential practice in self-regulation skills, and promote a positive parent-child relationship.
Treatment groups
Trial outcomes
Primary outcomes
Short-Form Children's Sleep Habits Questionnaire (SF-CSHQ)
Children's bedtime/sleep problems will be measured with the Short-Form Children's Sleep Habits Questionnaire (SF-CSHQ), a 23-item version of the widely used CSHQ. Respondents answer on a 5-point scale (1=never; 5=always-7x/week); a mean score will be computed and can range from 1 to 5, with higher scores indicating worse outcomes.
Child Adjustment & Parent Self-Efficacy Scale (CAPES) : Behavioral Problems Subscale
The Child Adjustment and Parent Efficacy Scale (CAPES) measures children's behaviors and emotional adjustment. The Behavior Problems subscale consists of 16 problematic and 8 reverse-coded positive behaviors. Respondents answer on a 4-point scale (0=Not at all; 3=Very much); the summed scores range from 0 to 72, with higher scores indicating worse outcomes.
Child Adjustment & Parent Self-Efficacy Scale (CAPES) : Emotional Maladjustment Subscale
The Child Adjustment and Parent Efficacy Scale (CAPES) measures children's behaviors and emotional adjustment. The Emotional Maladjustment subscale has 3 items. Respondents answer on a 4-point scale (0=Not at all; 3=Very much); the summed scores range from 0 to 9, with higher scores indicating worse outcomes.
Child Adjustment & Parent Self-Efficacy Scale (CAPES) : Parent Self-Efficacy Subscale
The Child Adjustment and Parent Efficacy Scale (CAPES) measures children's behaviors and emotional adjustment. The CAPES is also used to measure parents' self-efficacy; parents rate their confidence that they can successfully deal with each of the 19 negative behaviors/emotions on the CAPES. Respondents answer on a 10-point scale (1=Certain I can't do it; 10=Certain I can do it); the summed scores range from 19-190, with higher scores indicating better outcomes.
Secondary outcomes
Parental Stress Scale
The Parental Stress Scale (PSS) is comprised of 18 items that ask about positive (emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood. Respondents answer on a 5-point Likert "Strongly disagree" to "Strongly agree" scale in terms of their typical relationship with their child. An overall sum score is derived and can range from 18 to 90, with higher scores indicating worse outcomes.
Child-Parent Relationship Scale - Short Form: Conflicts Subscale
The Child-Parent Relationship Scale - Short Form (CPRS-SF) is comprised of 14 parent-report items that ask the parent for their assessment of the child-parent relationship, the child's emotional stance toward the parent, and the parent's feelings toward the child.Two subscales are derived: Conflicts and Positive Aspects/Closeness. The Conflicts subscale is measured by 7 items on a 5-point scale (1=Definitely does not apply; 5=Definitely applies); average scores range from 1 to 5, with higher scores indicating worse outcomes.
Child-Parent Relationship Scale - Short Form: Positive Aspects/Closeness Subscale
The Child-Parent Relationship Scale - Short Form (CPRS-SF) is comprised of 14 parent-report items that ask the parent for their assessment of the child-parent relationship, the child's emotional stance toward the parent, and the parent's feelings toward the child.Two subscales are derived: Conflicts and Positive Aspects/Closeness. The Closeness subscale is measured with 7 items on a 5-point scale (1 = Defintely does not apply; 5 = Defintely apply); average scores range from 1 to 5, with higher scores indicating better outcomes.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Research Behavioral Intervention Strategies, Inc.
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
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