Evaluation Study of Talk Parenting Skills

NCT04633434 | Completed Results

• 2 other identifiers: HD101190R43HD101190-01A1
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Feasibility; Satisfaction; Usability

Outcome Measures

Primary Outcomes (12)

• Parenting and Family Adjustment Scales (PAFAS): Positive Encouragement Subscale

  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)

• Parenting and Family Adjustment Scales (PAFAS) - Coercive Parenting Subscale

  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)

• Child Adjustment and Parent Self-Efficacy Scale (CAPES) - Emotional Adjustment 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. 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)

• Child Adjustment and Parent Self-Efficacy Scale (CAPES) - Behavior 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. 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)

• 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)

• Program-Targeted Parenting Practices - Frequency of Engagement Subscale

  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)

• Program-Targeted Parenting Practices - Self-Efficacy of Practice Subscale

  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)

• Program-Targeted Parenting Practices - Satisfaction Handling Bedtime Subscale

  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)

• Child-Parent Relationship Scale - Short Form (CPRS) - Closeness Subscale

  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)

• Child-Parent Relationship Scale - Short Form (CPRS) - Parent-Child Conflict Subscale

  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)

• 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). The value of one is subtracted from odd numbered items (1, 3, 5, 7, and 9) and the even number items (2, 4, 6, 8, and 10) are subtracted from the value of five. Scores are then summed and multiplied by 2.5 resulting in scores on a scale that ranges from 1 to 100, with higher scores indicating better usability.

  At 4 weeks after baseline (T2)

• Program Acceptability

  Program acceptability was measured with 7 items at T2, 4 weeks after baseline, asking the extent to which primary parents found the Talk Parenting skill useful, enjoyable, whether it addressed important topics, helped make bedtime more positive, enjoyment of use by child, how much use of bedtime strategies, and how much bedtime strategies helped the child and family. 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 Outcomes (8)

• Self-Efficacy for Parenting Tasks Index (SEPTI) - Toddler Scale - Discipline Subscale

  Baseline (T1), 4 weeks after baseline (T2)

• Self-Efficacy for Parenting Tasks Index (SEPTI) - Toddler Scale - Routine Subscale

  Baseline (T1), 4 weeks after baseline (T2)

• Parental Stress Scale (PSS)

  Baseline (T1), 4 weeks after baseline (T2)

• Families' Usage of the Talk Parenting (TP) Skill - Number of Families That Activated the Skill

  At 4 weeks after baseline (T2)

• Families' Usage of the Talk Parenting (TP) Skill - Number of Times Skill Was Used

  At 4 weeks after baseline (T2)

Study Arms (2)

The Talk Parenting Skill for Alexa - Parent

EXPERIMENTAL

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)

Behavioral: The Talk Parenting Skill for Alexa

The Talk Parenting Skill for Alexa - Child

EXPERIMENTAL

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

Behavioral: The Talk Parenting Skill for Alexa

Interventions

The Talk Parenting Skill for Alexa 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; The Talk Parenting Skill for Alexa - Parent

Eligibility Criteria

• Age: 3 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent learned about the study through a participating agency
• Child 3-5 years old who lives with the parent at least half time
• Parent puts the child to bed at least 2 nights per week
• Able to read and understand English
• Has access to the internet at home.

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; their needs are beyond the scope of Talk Parenting.

Sponsors & Collaborators

• Oregon Research Behavioral Intervention Strategies, Inc.: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

David R Smith

Eugene, Oregon, 97403, United States

Location

Related 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

  BACKGROUND

• 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.

  PMID: 28526249 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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

  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.

  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.

  PMID: 11145319 BACKGROUND

• 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.

  PMID: 23955254 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Child Behavior; Parasomnias; Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: David Smith
• Organization: Oregon Research Behavior Intervention Strategies, Inc. dba Influents Innovations

david.smith@influetnsin.com

541-484-2123

Study Officials

• David R Smith, Ph.D.

  Oregon Research Behavioral Interventions Strategies, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) 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.

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 18, 2020
• Study Start: September 1, 2021
• Primary Completion: February 16, 2024
• Study Completion: February 29, 2024
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)