Talk Parenting Education Program II

Utilizing Smart Speaker Technology to Deliver Parenting Education Support to Parents of Young Children

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.

Inclusion Criteria:

• 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
• Has access to a computer, tablet, or mobile phone at home
• Access to high-speed internet at home is desired but not required.

The project will cover internet costs for a small number of participants if needed. The participating agencies all serve families who are low-income and/or experiencing economic hardship, stressful family relationships, children's behavior problems, or household instability; thus referred families will be experiencing one or more of these risk factors for an at-risk family environment.

Exclusion Criteria:

• 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