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Not Yet RecruitingNCT07462052

Talk Parenting Education Program II

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
184 (estimated)
Sponsor
Oregon Research Behavioral Intervention Strategies, Inc. · Industry
Sex
All
Age
3 Years – 90 Years
Healthy volunteers
Accepted

Summary

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).

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALThe Talk Parenting ProgramIn 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.

Timeline

Start date
2026-07-01
Primary completion
2028-03-01
Completion
2028-04-01
First posted
2026-03-10
Last updated
2026-03-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07462052. Inclusion in this directory is not an endorsement.