NCT07462052

Brief 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 3, 2026

Last Update Submit

March 6, 2026

Conditions

Keywords

FeasibilitySatisfactionUsabilityEfficacy

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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).

    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).

    T1 (baseline), T2 (6 weeks after T1), T3 (3 months after T2 for Experimental, 6 weeks after T2 for Waitlist)

Secondary Outcomes (3)

  • Parental Stress Scale

    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

    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

    T1 (baseline), T2 (6 weeks after T1), T3 (3 months after T2 for Experimental, 6 weeks after T2 for Waitlist)

Study Arms (2)

Talk Parenting Program

EXPERIMENTAL

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.

Behavioral: The Talk Parenting Program

Waitlist Control

OTHER

Families will receive access to the intervention after the T2 assessment (6 weeks after the baseline T1 assessment).

Behavioral: The Talk Parenting Program

Interventions

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.

Talk Parenting ProgramWaitlist Control

Eligibility Criteria

Age3 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Behavioral Intervention Strategies, Inc.

Springfield, Oregon, 97477-2019, United States

Location

MeSH Terms

Conditions

Child BehaviorParasomniasPersonal Satisfaction

Condition Hierarchy (Ancestors)

BehaviorSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • David R Smith, PhD

    Oregon Research Behavioral Intervention Strategies, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 10, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations