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).
I. Study overview and rationale. This study is a two-arm randomized controlled trial designed to evaluate the efficacy, acceptability, and usability of Talk Parenting, a voice-delivered (Alexa-enabled) parenting support program intended to improve families' bedtime and morning routines for children ages 3-5 years. The trial will evaluate whether access to Talk Parenting leads to improvements in routine functioning (bedtime and morning experience), children's sleep/wake habits, parents' engagement in targeted parenting practices, parents' self-efficacy for handling routines and challenging child behavior, and the parent-child relationship, as well as reductions in children's behavior problems and parents' stress. II. Design. A total of 184 families (primary parent/caregiver and one child age 3-5 years who presents the most bedtime/morning challenges) will be enrolled and randomized after completing the baseline assessment (T1) to either: Immediate Talk Parenting (Tx): receive Talk Parenting immediately, or Waitlist Control (WC): wait 6 weeks to receive Talk Parenting while continuing to receive "care as usual" services through their parenting support agency. All participating families will be re-assessed (T2) 6 weeks after their baseline T1 assessment. At 6 weeks after T2, the WC group will complete their T3 assessment, and at 3 months after T2, the Tx condition will complete their T3 assessment. This design supports (1) a between-group efficacy test at 6 weeks post-baseline (Tx vs WC at T2), (2) a test of maintenance of gains in the Tx group from T2 to T3 (approximately 3 months after T2), and (3) an initial replication check of within-subject effects in the WC group after they receive the intervention (T2 to T3). III. Setting, recruitment, and population. Families will be recruited through community and early childhood service organizations in Oregon, including Head Start sites, Early Childhood Hubs, Parenting Now, WIC and Healthy Start in Lane County, and other similar parenting agencies. Participating families are expected to have risk factors that qualify them for services at these agencies (e.g., low income, family stress), and children may be at elevated risk for psychosocial/behavioral problems and/or poor school readiness. The study will over-enroll to account for anticipated attrition (planned \~30% attrition at T2 and \~40% at T3; target N at T2 is 128, 64 per group). IV. Intervention delivery and implementation. Families randomized to Tx will be provided a pre-configured Amazon Echo Dot and associated hardware, along with instructions to set up and initiate Talk Parenting. Talk Parenting will be enabled in a staged manner to support implementation: At initiation: Bedtime Routine and Calming Down Mini-Routine enabled After 2 weeks: Morning Routine enabled Tx families will have access to Bedtime/Calming routines for 6 weeks and Morning routine for 4 weeks prior to the 6-week assessment (T2). After WC families complete their 6-week assessment (T2), they will receive Talk Parenting using the same staged enablement process. Families keep the Echo Dot after participation. V. Study procedures and assessment schedule. Parents will complete questionnaires via the Qualtrics online platform at: T1 (baseline): prior to randomization T2 (6 weeks after T1): both Tx and WC T3 (follow-up): Tx: \~3 months after T2 WC: \~6 weeks after T2 (after receiving Talk Parenting) VI. Data sources and measurement domains (high level). Key domains assessed across T1/T2/T3 include: Parenting practices targeted to bedtime and morning routines Parenting self-efficacy related to routines and challenging child behaviors Parent stress Child sleep problems/behaviors Child behavioral and emotional adjustment Parent-child relationship quality For intervention engagement, Talk Parenting usage will be captured using objective usage metrics from the Alexa back-end database. Satisfaction, acceptability, usability, and problems/difficulties will be assessed at the post-intervention timepoint for each condition (T2 for Tx; T3 for WC). Demographics are collected at baseline (T1). VII. Feasibility and adoption (implementation-oriented outcomes). Commercial/implementation feasibility will be assessed via an advisory board and recruitment partners using a practitioner-focused satisfaction/acceptability measure to characterize acceptability for target families, feasibility for parenting education agencies, and interest in adopting Talk Parenting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
184
In 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.
Oregon Research Behavioral Intervention Strategies, Inc.
Springfield, Oregon, United States
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.
Time frame: T1 (baseline), T2 (6 weeks after T1), T3 (3 months after T2 for Experimental, 6 weeks after T2 for Waitlist)
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.
Time frame: T1 (baseline), T2 (6 weeks after T1), T3 (3 months after T2 for Experimental, 6 weeks after T2 for Waitlist)
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.
Time frame: T1 (baseline), T2 (6 weeks after T1), T3 (3 months after T2 for Experimental, 6 weeks after T2 for Waitlist)
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.
Time frame: T1 (baseline), T2 (6 weeks after T1), T3 (3 months after T2 for Experimental, 6 weeks after T2 for Waitlist)
Self-Efficacy for Parenting Tasks Index - Toddler Scale (SEPTI-TS): Discipline Subscale
The Self-Efficacy for Parenting Tasks Index - Toddler Scale - Short Form (SEPTI-TS-SF) is used to measure parents' self-efficacy for discipline- and routines-related parenting tasks. The Discipline subscale is measured with 6 items. Respondents answer on a 6-point scale (1=Disagree strongly; 6=Agree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Time frame: T1 (baseline), T2 (6 weeks after T1), T3 (3 months after T2 for Experimental, 6 weeks after T2 for Waitlist)
Self-Efficacy for Parenting Tasks Index - Toddler Scale (SEPTI-TS): Routines Subscale
The Self-Efficacy for Parenting Tasks Index - Toddler Scale - Short Form (SEPTI-TS-SF) is used to measure parents' self-efficacy for a discipline- and routines-related parenting tasks. The Routines subscales are measured with 6 items each. Respondents answer on a 6-point scale (1=Disagree strongly; 6=Agree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes.
Time frame: T1 (baseline), T2 (6 weeks after T1), T3 (3 months after T2 for Experimental, 6 weeks after T2 for Waitlist)
Engagement in Program-Targeted Parenting Practices (PTPP) - Parent's Self Efficacy Scale
Parents' self-efficacy for engaging in the parenting practices targeted by the intervention is measured via the Engagement in Target Activities with Child measure, Parents' Self-Efficacy subscale. Created for this study, these number of items will be determined and will items ask parents to rate how confident they are that they know how to do a series of parenting practices targeted by the program, on a scale of 1 to 10 (1 = Not at all confident; 10 = Highly confident). Average scores range from 1 to 10, with higher scores indicating greater parental self-efficacy (better outcome).
Time frame: T1 (baseline), T2 (6 weeks after T1), T3 (3 months after T2 for Experimental, 6 weeks after T2 for Waitlist)
Engagement in Program-Targeted Parenting Practices (PTPP) - Frequency Subscale
The frequency of parents' engagement in the parenting practices targeted by the intervention is measured via the Engagement in Target Activities with Child measure, Frequency subscale. Created for this study, the number of items will be determined and will ask parents to report the frequency with which they have engaged in target parenting practices in the past 4 weeks. Parents report their frequency on a 6-point scale (0 = "Never in the past month" to 5 = "Every day in past month:). Averaged scores range from 0 to 5, with higher scores indicating more frequent parental engagement in the target activities (better outcome).
Time frame: T1 (baseline), T2 (6 weeks after T1), T3 (3 months after T2 for Experimental, 6 weeks after T2 for Waitlist)
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.
Time frame: T1 (baseline), T2 (6 weeks after T1), T3 (3 months after T2 for Experimental, 6 weeks after T2 for Waitlist)
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.
Time frame: T1 (baseline), T2 (6 weeks after T1), T3 (3 months after T2 for Experimental, 6 weeks after T2 for Waitlist)
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.
Time frame: T1 (baseline), T2 (6 weeks after T1), T3 (3 months after T2 for Experimental, 6 weeks after T2 for Waitlist)
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