Evaluation Study of Talk Parenting Skills

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04633434
• Other study ID #: HD101190
• Secondary ID: R43HD101190-01A1
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: March 8, 2024

Study information

• Verified date: January 2024
• Source: Oregon Research Behavioral Intervention Strategies, Inc.
• Contact: David R Smith, Ph.D.
• Phone: 5414842123
• Email: David.Smith[@]influentsin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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). 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).

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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: March 8, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 90 Years

Eligibility

Inclusion:

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.

Related Conditions & MeSH terms

• Child Behavior
• Dyssomnias
• Emotional Adjustment
• Parasomnias
• Parent-Child Relations
• Parenting Practices
• Self Efficacy
• Sleep Problems
• Stress

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	David R Smith	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Research Behavioral Intervention Strategies, Inc.	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (9)

Berry JO, Jones WH. The Parental Stress Scale: Initial Psychometric Evidence. Journal of Social and Personal Relationships. 1995; 12(3): 463-472. doi:10.1177/0265407595123009

Bonuck KA, Goodlin-Jones BL, Schechter C, Owens J. Modified Children's sleep habits questionnaire for behavioral sleep problems: A validation study. Sleep Health. 2017 Jun;3(3):136-141. doi: 10.1016/j.sleh.2017.03.009. Epub 2017 Apr 8. — View Citation

Brooke J. System Usability Scale (SUS): A quick and dirty usability scale. Digital Equipment Corporation. 1986. Retrieved 1/2/18 from usability.gov website: https://www.usability.gov/how-to-andtools/methods/system-usability-scale.html

Driscoll K, Pianta RC. Mothers' and fathers' perceptions of conflict and closeness in parent-child relationships during early childhood. Journal of Early Childhood and Infant Psychology. 2011; 7: 1-24.

Louie AD, Cromer LD, Berry JO. Assessing parenting stress: Review of the use and interpretation of the Parental Stress Scale. The Family Journal, 2017; 25: 359-367. doi:10.1177/1066480717731347

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.

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. — View Citation

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. — View Citation

Zelman JJ, Ferro MA. The Parental Stress Scale: Psychometric properties in families of children with chronic health conditions. Family Relations. 2018; 67(2): 240-252.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parenting and Family Adjustment Scales (PAFAS)	The Positive Encouragement and Coercive Parenting subscales of the Parenting and Family Adjustment Scales (PAFAS) are used to measure parents' positive encouragement and coercive parenting. The Positive Encouragement subscale is measured with three items, answered on a 4-point scale (0=Not at all; 3=Very much); summed scores range from 0 to 9, with higher scores indicating worse outcomes. The Coercive Parenting subscale is measured with five items, answered on the same 4-point scale; summed scores range from 0 to 15, with higher scores indicating worse outcomes. Each subscale shows good internal consistency and construct validity.	Baseline (T1), 4 weeks after baseline (T2)
Primary	Child Adjustment and Parent Self-Efficacy Scale (CAPES)	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. The Emotional Maladjustment subscale has 3 items. Respondents answer on the same 4-point scale; the summed scores range from 0 to 9, with higher scores indicating worse outcomes. 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.	Baseline (T1), 4 weeks after baseline (T2)
Primary	Short-Form Children's Sleep Habits Questionnaire (SF-CSHQ)	Children's bedtime/sleep problems is measured with the Short-Form Children's Sleep Habits Questionnaire (SF-CSHQ), a 23-item version of the widely used Children's Sleep Habits Questionnaire (CSHQ). Respondents answer on a 5-point scale (1=never; 5=always); average scores range from 1 to 5, with higher scores indicating worse outcomes. The SF-CSHQ shows good validity against the original CSHQ, external validity, internal reliability, and sensitivity to change.	Baseline (T1), 4 weeks after baseline (T2)
Primary	Program-Targeted Parenting Practices	Frequency of parents' engagement in the parenting practices targeted by the intervention, and parents' self-efficacy for doing so, are measured by the Program-Targeted Parenting Practices measure. Created by the Investigators, 14 items ask parents to report the frequency with which they have engaged in target parenting practices related to bedtime in the past 4 weeks, on a 6-point scale (0=Never in past month; 5=Every day in past month); average scores range from 0 to 5, higher scores indicating better outcomes. Then parents are asked to rate how confident they are in doing 12 of these target parenting practices, on a 10-point scale (1=Not at all confident; 10=Highly confident); average scores range from 1 to 10, higher scores indicating better outcomes. Finally, 3 items ask parents for their satisfaction with how child's bedtime is going, on a 10-point scale (0=Not at all satisfied; 10=Very satisfied); average scores range from 1 to 10, higher scores indicating better outcomes.	Baseline (T1), 4 weeks after baseline (T2)
Primary	Child-Parent Relationship Scale - Short Form (CPRS)	The Child-Parent Relationship Scale - Short Form (CPRS-SF) is used to measure the degree of closeness and conflict in the parent-child relationship. The CPRS-SF is comprised of 15 parent-report items that ask the parent for their assessment of the child-parent relationship, the child's emotional stance toward the parent, and the parent's feelings toward the child. Two subscales are derived: Conflicts and Positive Aspects/Closeness. The Conflicts subscale is measured by 7 items on a 5-point scale (1=Definitely does not apply; 5=Definitely applies); average scores range from 1 to 5, with higher scores indicating worse outcomes. The Closeness subscale is measured with 7 items on the same 5-point scale; average scores range from 1 to 5, with higher scores indicating better outcomes. The CPRS-SF has been validated with parents of preschoolers and first graders and shows good internal consistency.	Baseline (T1), 4 weeks after baseline (T2)
Primary	System Usability Scale (SUS)	Skill usability is measured with the System Usability Scale (SUS), a commonly used 10-item scale that measures subjective perceptions of usability. Items are answered on a 5-point scale (1=Strongly disagree; 5=Strongly agree); scores on the scale range from 1 to 100, with higher scores indicating better usability.	At 4 weeks after baseline (T2)
Primary	Program Satisfaction	Program Satisfaction is measured with 14 items at T2, 4 weeks after baseline, asking the extent to which primary parents found the Talk Parenting skill helpful, acceptable, and suited to their needs. These questions also ask about any problems experienced, frustrations, behaviors or relationships made worse, or points of dissatisfaction. Respondents answer items on a 7-point scale (1=Not at all; 7=Very much); average scores range from 1 to 7, with higher scores indicating better satisfaction.	At 4 weeks after baseline (T2)
Secondary	Self-Efficacy for Parenting Tasks Index (SEPTI) - Toddler Scale - Short Form	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 Discipline and Routines subscales are measured with 6 items each. Respondents answer on a 6-point scale (1=Agree strongly; 6=Disagree strongly); average scores range from 1 to 6, with higher scores indicating better outcomes. These SEPTI-TS-SF subscales show good internal consistency, construct validity, and discriminant validity, and sensitivity to change.	Baseline (T1), 4 weeks after baseline (T2)
Secondary	Parental Stress Scale (PSS)	The Parental Stress Scale (PSS) is used to measure parents' stress level. The PSS is comprised of 18 items that ask about positive (emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood. Respondents answer on a 5-point scale (1=Strongly disagree; 5=Strongly agree); summed scores range from 18 to 90, with higher scores indicating worse outcomes. The PSS shows good internal consistency, test-retest reliability, discriminant validity, and construct validity and has been validated across cultures and languages, with families of typically developing children, and with families of children with emotional/ behavioral problems, developmental disabilities, and chronic health conditions.	Baseline (T1), 4 weeks after baseline (T2)
Secondary	Families' usage of the Talk Parenting (TP) skill	Families' usage of the TP skill is measured 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.	At 4 weeks after baseline (T2)
Secondary	Demographics	Family demographics (household composition, ethnicity/race, education level, income, economic hardship, employment, etc.) is measured on the parent questionnaire at baseline only.	Baseline (T1)
Secondary	Commercial Feasibility	Commercial feasibility is measured with the Practitioner Satisfaction and Program Acceptability measure, 20 items that Advisory Board members and recruitment partners 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.	End of Study (1 year)