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Evaluation Study of Talk Parenting Skills

Primary Purpose

Parenting Practices, Self Efficacy, Stress

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Talk Parenting Skill for Alexa
Sponsored by
Oregon Research Behavioral Intervention Strategies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parenting Practices focused on measuring Feasibillity, Satisfaction, Usability

Eligibility Criteria

3 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion:

  1. Referred by a participating agency
  2. Child 3-5 years old who lives with the parent at least half time
  3. The primary parent in the home (typically the mother but not always)
  4. Speaks English
  5. Has access to email. Access to high-speed internet at home is desired but not required. The participating agencies all serve families who are low-income and/or experiencing economic hardship, stressful family relationships, children's behavior problems, parental adjustment issues (mental health, substance use), or household instability; thus referred families will be experiencing one or more of these risk factors for a high-risk family environment.

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.

Sites / Locations

  • David R SmithRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The Talk Parenting Skill for Alexa

Arm Description

52 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 6 weeks, and then re-assessed at 6 weeks (at treatment completion)

Outcomes

Primary Outcome Measures

Parenting & Family Adjustment scales (PAFAS)
Measure change using the Parenting & Family Adjustment Scales; the PAFAS is used to measure change in parenting practices, parents' stress, and the parent-child relationship. The 30 items on the PAFAS sort into 7 subscales with good internal consistency and construct validity: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner. The PAFAS will be adapted to include additional items about the presence of a bedtime routine and parents' satisfaction with how that routine is going.
Child Adjustment & Parent Self-Efficacy Scale (CAPES)
Measure change using The Child Adjustment & Parent Efficacy Scale (CAPES) in children's behaviors and emotional adjustment. The Behavior Problems subscale consists of 16 problematic and 8 reverse-coded positive behaviors; the Emotional Maladjustment subscale has 3 items. The CAPES is highly correlated with the Eyberg Child Behavior Inventory (ECBI), a common measure for children's behavior problems, but the CAPES has the added advantage that it includes positive behavior items and emotional maladjustment, and is less burdensome for parents to complete. The CAPES will also be used to measure parent's self-efficacy; parents rate their confidence that they can successfully deal with each of the 19 negative behaviors/emotions on the CAPES. The CAPES will be adapted to include additional items about the child's cooperation before bed at bedtime.
Short-Form Children's Sleep Habits Questionnaire (SF-CSHQ)
Measure change in Children's bedtime/sleep problems; the Short-Form Children's Sleep Habits Questionnaire (SF-CSHQ), a 23-item version of the widely used CSHQ. The SF-CSHQ shows good validity against the original CSHQ, external validity, internal reliability, and sensitivity to change.
System Usability scale (SUS)
Skill usability will be measured with the System Usability Scale (SUS), a commonly used 10-item scale that measures subjective perceptions of usability.
Program Satisfaction
Parent Satisfaction will measure with 14 items at 6 weeks (at treatment completion), asking the extent to which primary parents found the Talk Parenting skill helpful, acceptable, and suited to their needs. We will also ask about any problems experienced, frustrations, behaviors or relationships made worse, or points of dissatisfaction.

Secondary Outcome Measures

Families' usage of the TP skill
Families' usage of the TP skill will measure through usage metrics and transcripts collected on the back-end database, including activation of the skill; which scripts are accessed and by whom; frequency, timing, and duration of engagements; elapsed time to accomplish the bedtime routine; and points of difficulty or failure.
Demographics
Family demographics (household composition, ethnicity/race, education level, income, economic hardship, employment, etc.) will be measured on the parent questionnaire at pretest only.
Commercial Feasibility
Commercial feasibility will be measured using the Practitioner Satisfaction & Program Acceptability measure, 20 items that Advisory Board members and recruitment partners will complete. These items measure Talk Parenting's acceptability for the target families these practitioners serve, feasibility for parenting education agencies, and their interest in purchasing and adopting TP.

Full Information

First Posted
October 28, 2020
Last Updated
October 24, 2023
Sponsor
Oregon Research Behavioral Intervention Strategies, Inc.
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04633434
Brief Title
Evaluation Study of Talk Parenting Skills
Official Title
Utilizing Smart Speaker Technology to Deliver Parenting Education Support to Parents of Young Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 5, 2024 (Anticipated)
Study Completion Date
January 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Behavioral Intervention Strategies, Inc.
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 52 at-risk families (52 primary parents, 52 target children, and 34 second parents). 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 6 weeks. They will then be re-assessed with the online questionnaire at 6 weeks (at treatment completion).
Detailed Description
Parents will 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 will complete the enrollment questionnaire via the Qualtrics online assessment platform and then be provided an Echo Dot with the Bedtime Routine module enabled. After 6 weeks, they will be administered the 6 weeks (at treatment completion)questionnaire. This design will allow us to evaluate enrollment-6 weeks (at treatment completion) change and satisfaction/usability of the Bedtime Routine prototype module. Enrollment and 6 weeks (at treatment completion) questionnaires will measure primary parents' parenting practices, self-efficacy, and stress; children's behavior, emotional adjustment, and sleep problems; and the parent-child relationship. The 6 weeks (at treatment completion) questionnaire will also contain measures of parent satisfaction, acceptability, and usability of the Talk Parenting skill, as well as any difficulties experienced or problems made worse. Demographics will be collected at enrollment. Enrollment and 6 weeks (at treatment completion) questionnaires will be administered via Qualtrics, an online assessment tool. Project staff will follow-up with parents as needed to encourage questionnaire completion in a timely manner. Parents will be paid $20 per assessment. The investigators will provide families an Echo Dot device and enable the skill using a research Amazon account created for each family. The Echo Dot devices will be 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 will be preconfigured by project staff onto research Amazon accounts. Families without broadband internet access at home will be provided a hotspot to allow high-speed access. All families will be provided a pre-configured wifi adaptor that creates a wifi network specific for the Echo Dot device to connect to. After enrollment, primary parents will come to one of several orientation sessions to obtain their Echo Dot device, portable auxiliary battery pack, wifi adaptor, and set-up instructions; staff will provide follow-up phone support as needed. Usage data will show whether families have used the device; the investigators will call to assist set up if parents have not enabled/used the device within 2 weeks. To ensure exposure to Talk Parenting, parents will be asked to engage with the skill at least twice per week; project staff will prompt parents two times (via text, email, device notification, or phone, depending on parent's preference) during the 6-week session to encourage usage and provide technical support as needed. Two reminders is viewed as having external validity; a parenting education agency providing Talk Parenting to client families could conceivably check in with parents a couple of times to remind them to use the tool and see how it is going. At the end of the study, families will be asked to return the wifi adaptor to the project offices; they will be free to keep the Echo Dot device and auxiliary battery pack.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenting Practices, Self Efficacy, Stress, Child Behavior, Emotional Adjustment, Sleep Problems, Parent-Child Relations
Keywords
Feasibillity, Satisfaction, Usability

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Type Name Description Behavioral (e.g., Psychotherapy, Lifestyle Counseling) The Talk Parenting skill for Alexa In a 6-week session, families will 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 will guide 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The Talk Parenting Skill for Alexa
Arm Type
Experimental
Arm Description
52 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 6 weeks, and then re-assessed at 6 weeks (at treatment completion)
Intervention Type
Device
Intervention Name(s)
The Talk Parenting Skill for Alexa
Intervention Description
In a 6-week session, families will 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 will guide 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.
Primary Outcome Measure Information:
Title
Parenting & Family Adjustment scales (PAFAS)
Description
Measure change using the Parenting & Family Adjustment Scales; the PAFAS is used to measure change in parenting practices, parents' stress, and the parent-child relationship. The 30 items on the PAFAS sort into 7 subscales with good internal consistency and construct validity: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner. The PAFAS will be adapted to include additional items about the presence of a bedtime routine and parents' satisfaction with how that routine is going.
Time Frame
Enrollment, 6 weeks (at treatment completion)
Title
Child Adjustment & Parent Self-Efficacy Scale (CAPES)
Description
Measure change using The Child Adjustment & Parent Efficacy Scale (CAPES) in children's behaviors and emotional adjustment. The Behavior Problems subscale consists of 16 problematic and 8 reverse-coded positive behaviors; the Emotional Maladjustment subscale has 3 items. The CAPES is highly correlated with the Eyberg Child Behavior Inventory (ECBI), a common measure for children's behavior problems, but the CAPES has the added advantage that it includes positive behavior items and emotional maladjustment, and is less burdensome for parents to complete. The CAPES will also be used to measure parent's self-efficacy; parents rate their confidence that they can successfully deal with each of the 19 negative behaviors/emotions on the CAPES. The CAPES will be adapted to include additional items about the child's cooperation before bed at bedtime.
Time Frame
Enrollment, 6 weeks (at treatment completion)
Title
Short-Form Children's Sleep Habits Questionnaire (SF-CSHQ)
Description
Measure change in Children's bedtime/sleep problems; the Short-Form Children's Sleep Habits Questionnaire (SF-CSHQ), a 23-item version of the widely used CSHQ. The SF-CSHQ shows good validity against the original CSHQ, external validity, internal reliability, and sensitivity to change.
Time Frame
Enrollment, 6 weeks (at treatment completion)
Title
System Usability scale (SUS)
Description
Skill usability will be measured with the System Usability Scale (SUS), a commonly used 10-item scale that measures subjective perceptions of usability.
Time Frame
At 6 weeks (treatment completion)
Title
Program Satisfaction
Description
Parent Satisfaction will measure with 14 items at 6 weeks (at treatment completion), asking the extent to which primary parents found the Talk Parenting skill helpful, acceptable, and suited to their needs. We will also ask about any problems experienced, frustrations, behaviors or relationships made worse, or points of dissatisfaction.
Time Frame
At 6 weeks (treatment completion)
Secondary Outcome Measure Information:
Title
Families' usage of the TP skill
Description
Families' usage of the TP skill will measure through usage metrics and transcripts collected on the back-end database, including activation of the skill; which scripts are accessed and by whom; frequency, timing, and duration of engagements; elapsed time to accomplish the bedtime routine; and points of difficulty or failure.
Time Frame
At 6 weeks (treatment completion)
Title
Demographics
Description
Family demographics (household composition, ethnicity/race, education level, income, economic hardship, employment, etc.) will be measured on the parent questionnaire at pretest only.
Time Frame
Enrollment
Title
Commercial Feasibility
Description
Commercial feasibility will be measured using the Practitioner Satisfaction & Program Acceptability measure, 20 items that Advisory Board members and recruitment partners will complete. These items measure Talk Parenting's acceptability for the target families these practitioners serve, feasibility for parenting education agencies, and their interest in purchasing and adopting TP.
Time Frame
Month 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion: 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 email. Access to high-speed internet at home is desired but not required. The participating agencies all serve families who are low-income and/or experiencing economic hardship, stressful family relationships, children's behavior problems, parental adjustment issues (mental health, substance use), or household instability; thus referred families will be experiencing one or more of these risk factors for a high-risk family environment. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David R Smith, Ph.D.
Phone
5414842123
Email
David.Smith@influentsin.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Smith, Ph.D.
Organizational Affiliation
Oregon Research Behavioral Interventions Strategies, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
David R Smith
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David R Smith, PhD
Phone
541-484-2123
Email
David.Smith@influentsin.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation Study of Talk Parenting Skills

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