Evaluation Study of Talk Parenting Skills

NCT ID: NCT04633434

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-02-29

Brief Summary

After development of the prototype Bedtime Routine module of the Talk Parenting program, the investigators will evaluate its feasibility and initial efficacy in a within-subjects pre-post design study. Through recruitment partner agencies, the investigators will recruit a sample of 49 at-risk families (49 primary parents, 49 target children). Primary parents will be assessed at enrollment via online an questionnaire, then provided an Amazon Echo Dot and asked to use the Bedtime Routine module for 4 weeks. They will then be re-assessed with the online questionnaire at 4 weeks (at treatment completion). Although children were considered enrolled participants that actively participate in the intervention, we obtained no assessment data from the children themselves.

Detailed Description

Parents provide consent for their own participation, as well as the participation of their target child (their child aged 3-5 years who presents the most behavioral challenges). After consent, primary parents complete the baseline (T1) questionnaire via the Qualtrics online assessment platform and then are provided an Echo Dot with the Bedtime Routine module enabled. After 4 weeks post-baseline, they are administered the T2 questionnaire. This design allows evaluation of T1-T2 change and satisfaction/usability of the Bedtime Routine prototype module. Although children were considered enrolled participants that actively participate in the intervention, we obtained no assessment data from the children themselves.

T1 and T2 questionnaires measure primary parents' parenting practices, self-efficacy, and stress; children's behavior, emotional adjustment, and sleep problems; and the parent-child relationship. The T2 questionnaire also contains measures of parent satisfaction, acceptability, and usability of the Talk Parenting skill, as well as any difficulties experienced, or problems made worse. Demographics are collected at T1. T1 and T2 questionnaires are administered via Qualtrics, an online assessment tool. Project staff follow-up with parents as needed to encourage questionnaire completion in a timely manner. Parents are paid $20 per assessment.

Families are provided an Echo Dot device with the Talk Parenting skill already enabled using a research Amazon account created for each family. The Echo Dot devices are paired with portable auxiliary battery packs to enable mobile use within the home, so that the device can be carried from room to room during execution of the bedtime routine. The devices are preconfigured by project staff onto research Amazon accounts. All families are provided a pre-configured wifi adaptor that creates a wifi network specific for the Echo Dot device to connect to. After the baseline assessment (T1), primary parents are mailed their Echo Dot device, portable auxiliary battery pack, wifi adaptor, and set-up instructions; staff provide follow-up phone support as needed. Usage data show whether families have used the device; project staff contact the parents to assist set up if parents have not enabled/used the device within 2 weeks. To ensure exposure to Talk Parenting, parents are asked to engage with the skill at least twice per week (or at least eight times); project staff prompt parents two to three times (via text, email, or phone, depending on parents' preference) during the 4-week period to encourage usage and provide technical support as needed.

At the end of the study, families are asked to return the wifi adaptor to the project offices; families are free to keep the Echo Dot device and auxiliary battery pack.

Conditions

Parenting Practices; Self Efficacy; Stress; Child Behavior; Emotional Adjustment; Sleep Problems; Parent-Child Relations

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

The Talk Parenting Skill for Alexa - Parent

49 parents will be assessed at enrollment, then provided an Amazon Echo Dot and exposed to the prototype Bedtime Routine module of the Talk Parenting program for 4 weeks, and then re-assessed at 4 weeks (at treatment completion)

Group Type: EXPERIMENTAL

The Talk Parenting Skill for Alexa

Intervention Type: BEHAVIORAL

In a 4-week period, families use at home a prototype Bedtime Routine module of the Talk Parenting program, a smart speaker app designed to provide parents with in-situ experiential support for building positive family routines. The prototype Bedtime Routine module of Talk Parenting guides families in creating a healthy bedtime routine to foster healthy sleep habits, provide experiential practice in self-regulation skills, and promote a positive parent-child relationship.

The Talk Parenting Skill for Alexa - Child

Although 49 children were considered enrolled participants that actively participate in the intervention, we obtained no assessment data from the children themselves.

Group Type: EXPERIMENTAL

The Talk Parenting Skill for Alexa

Intervention Type: BEHAVIORAL

In a 4-week period, families use at home a prototype Bedtime Routine module of the Talk Parenting program, a smart speaker app designed to provide parents with in-situ experiential support for building positive family routines. The prototype Bedtime Routine module of Talk Parenting guides families in creating a healthy bedtime routine to foster healthy sleep habits, provide experiential practice in self-regulation skills, and promote a positive parent-child relationship.

Interventions

The Talk Parenting Skill for Alexa

In a 4-week period, families use at home a prototype Bedtime Routine module of the Talk Parenting program, a smart speaker app designed to provide parents with in-situ experiential support for building positive family routines. The prototype Bedtime Routine module of Talk Parenting guides families in creating a healthy bedtime routine to foster healthy sleep habits, provide experiential practice in self-regulation skills, and promote a positive parent-child relationship.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Parent learned about the study through a participating agency

2. Child 3-5 years old who lives with the parent at least half time

3. Parent puts the child to bed at least 2 nights per week

4. Able to read and understand English

5. Has access to the internet at home.

Exclusion:

1. Families of target-age children with a developmental disability severe enough that the child cannot speak or follow simple directions will be excluded; their needs are beyond the scope of Talk Parenting.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Oregon Research Behavioral Intervention Strategies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David R Smith, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Behavioral Interventions Strategies, Inc.

Locations

David R Smith

Eugene, Oregon, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 28526249 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

Morawska A, Sanders MR, Haslam D, Filus A, Fletcher R. Child Adjustment & Parent Efficacy Scales (CAPES): Development and initial validation of a parent-report measure. Australian Psychologist. 2014; 49: 241-252.

Reference Type: BACKGROUND

Owens JA, Spirito A, McGuinn M. The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Sleep. 2000 Dec 15;23(8):1043-51.

Reference Type: BACKGROUND

PMID: 11145319 (View on PubMed)

Sanders MR, Morawska A, Haslam DM, Filus A, Fletcher R. Parenting and Family Adjustment Scales (PAFAS): validation of a brief parent-report measure for use in assessment of parenting skills and family relationships. Child Psychiatry Hum Dev. 2014 Jun;45(3):255-72. doi: 10.1007/s10578-013-0397-3.

Reference Type: BACKGROUND

PMID: 23955254 (View on PubMed)

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Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R43HD101190-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HD101190

Identifier Type: -

Identifier Source: org_study_id