Parenting PracticesNCT04633434
Evaluation Study of Talk Parenting Skills
A study testing The Talk Parenting Skill for Alexa in people with Parenting Practices and Self Efficacy, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parenting Practices, Self Efficacy, Stress
- What is being tested?
- The Talk Parenting Skill for Alexa
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilizing Smart Speaker Technology to Deliver Parenting Education Support to Parents of Young Children
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.
Read the 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
- Being tested
- The Talk Parenting Skill for Alexa
- Keywords
- Feasibility, Satisfaction, Usability
- Medical subject headings
- Child Behavior, Parasomnias, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Talk Parenting Skill for AlexaBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Behavioral: The Talk Parenting Skill for Alexa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 4 weeks after baseline (T2)
Secondary outcomes (8)
Self-Efficacy for Parenting Tasks Index (SEPTI) - Toddler Scale - Discipline 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 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.
Measured: Baseline (T1), 4 weeks after baseline (T2)
Self-Efficacy for Parenting Tasks Index (SEPTI) - Toddler Scale - Routine 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 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.
Measured: Baseline (T1), 4 weeks after baseline (T2)
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.
Measured: Baseline (T1), 4 weeks after baseline (T2)
Families' Usage of the Talk Parenting (TP) Skill - Number of Families That Activated the Skill
Families' usage of the TP skill is measured through usage metrics and transcripts collected on the back-end database, including number of families that activated the skill, number of times skill was used, number of steps a family used, length of bedtime routine in minutes, and number of families that listened to a podcast. Higher levels for all metrics indicate greater skill use.
Measured: At 4 weeks after baseline (T2)
Families' Usage of the Talk Parenting (TP) Skill - Number of Times Skill Was Used
Families' usage of the TP skill is measured through usage metrics and transcripts collected on the back-end database, including number of families that activated the skill, number of times skill was used, number of steps a family used, length of bedtime routine in minutes, and number of families that listened to a podcast. Higher levels for all metrics indicate greater skill use.
Measured: At 4 weeks after baseline (T2)
Families' Usage of the Talk Parenting (TP) Skill - Number of Steps Used
Families' usage of the TP skill is measured through usage metrics and transcripts collected on the back-end database, including number of families that activated the skill, number of times skill was used, number of steps a family used, length of bedtime routine in minutes, and number of families that listened to a podcast. Higher levels for all metrics indicate greater skill use.
Measured: At 4 weeks after baseline (T2)
Families' Usage of the Talk Parenting (TP) Skill - Length of Bedtime Routine
Families' usage of the TP skill is measured through usage metrics and transcripts collected on the back-end database, including number of families that activated the skill, number of times skill was used, number of steps a family used, length of bedtime routine in minutes, and number of families that listened to a podcast. Higher levels for all metrics indicate greater skill use.
Measured: At 4 weeks after baseline (T2)
Families' Usage of the Talk Parenting (TP) Skill - Listened to a Podcast
Families' usage of the TP skill is measured through usage metrics and transcripts collected on the back-end database, including number of families that activated the skill, number of times skill was used, number of steps a family used, length of bedtime routine in minutes, and number of families that listened to a podcast. Higher levels for all metrics indicate greater skill use.
Measured: At 4 weeks after baseline (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Sep 2021
- Primary completion16 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Parenting PracticesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- David R Smith, Ph.D., Principal investigator, Oregon Research Behavioral Interventions Strategies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633434
- Sponsor's protocol ID
- HD101190
- Other IDs
- R43HD101190-01A1
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2020
- Last updated
- 21 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28526249Brooke 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.
PubMed 11145319Sanders 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.
PubMed 23955254Zelman JJ, Ferro MA. The Parental Stress Scale: Psychometric properties in families of children with chronic health conditions. Family Relations. 2018; 67(2): 240-252.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Smart Speaker Technology to Deliver Parenting Education Support to Parents of Young Children
- ClinicalTrials.gov ID
- NCT04633434
- Acronym / sponsor ID
- HD101190
- Conditions
- Parenting Practices, Self Efficacy, Stress, Child Behavior, Emotional Adjustment, Sleep Problems
- Keywords
- Feasibility, Satisfaction, Usability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Posted 21 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| The Talk Parenting Skill for Alexa - Parent | Experimental | Behavioral: The Talk Parenting Skill for Alexa49 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) |
| The Talk Parenting Skill for Alexa - Child | Experimental | Behavioral: The Talk Parenting Skill for AlexaAlthough 49 children were considered enrolled participants that actively participate in the intervention, we obtained no assessment data from the children themselves. |
Who may qualify
- Ages
- 3 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Talk Parenting Skill for AlexaIn 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. | Behavioural | The Talk Parenting Skill for Alexa - Child, The Talk Parenting Skill for Alexa - Parent |
Primary outcome
Parenting and Family Adjustment Scales (PAFAS): Positive Encouragement Subscale
Time frame: Baseline (T1), 4 weeks after baseline (T2)
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.
Parenting and Family Adjustment Scales (PAFAS) - Coercive Parenting Subscale
Time frame: Baseline (T1), 4 weeks after baseline (T2)
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.
Child Adjustment and Parent Self-Efficacy Scale (CAPES) - Emotional Adjustment Subscale
Time frame: Baseline (T1), 4 weeks after baseline (T2)
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.
Child Adjustment and Parent Self-Efficacy Scale (CAPES) - Behavior Problems Subscale
Time frame: Baseline (T1), 4 weeks after baseline (T2)
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.
Short-Form Children's Sleep Habits Questionnaire (SF-CSHQ)
Time frame: Baseline (T1), 4 weeks after baseline (T2)
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.
Program-Targeted Parenting Practices - Frequency of Engagement Subscale
Time frame: Baseline (T1), 4 weeks after baseline (T2)
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.
Program-Targeted Parenting Practices - Self-Efficacy of Practice Subscale
Time frame: Baseline (T1), 4 weeks after baseline (T2)
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.
Program-Targeted Parenting Practices - Satisfaction Handling Bedtime Subscale
Time frame: Baseline (T1), 4 weeks after baseline (T2)
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.
Child-Parent Relationship Scale - Short Form (CPRS) - Closeness Subscale
Time frame: Baseline (T1), 4 weeks after baseline (T2)
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.
Child-Parent Relationship Scale - Short Form (CPRS) - Parent-Child Conflict Subscale
Time frame: Baseline (T1), 4 weeks after baseline (T2)
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.
System Usability Scale (SUS)
Time frame: At 4 weeks after baseline (T2)
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.
Program Acceptability
Time frame: At 4 weeks after baseline (T2)
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.
8 secondary outcomes
Self-Efficacy for Parenting Tasks Index (SEPTI) - Toddler Scale - Discipline Subscale
Time frame: Baseline (T1), 4 weeks after baseline (T2)
Self-Efficacy for Parenting Tasks Index (SEPTI) - Toddler Scale - Routine Subscale
Time frame: Baseline (T1), 4 weeks after baseline (T2)
Parental Stress Scale (PSS)
Time frame: Baseline (T1), 4 weeks after baseline (T2)
Families' Usage of the Talk Parenting (TP) Skill - Number of Families That Activated the Skill
Time frame: At 4 weeks after baseline (T2)
Families' Usage of the Talk Parenting (TP) Skill - Number of Times Skill Was Used
Time frame: At 4 weeks after baseline (T2)
Families' Usage of the Talk Parenting (TP) Skill - Number of Steps Used
Time frame: At 4 weeks after baseline (T2)
Families' Usage of the Talk Parenting (TP) Skill - Length of Bedtime Routine
Time frame: At 4 weeks after baseline (T2)
Families' Usage of the Talk Parenting (TP) Skill - Listened to a Podcast
Time frame: At 4 weeks after baseline (T2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBerry 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: PubMed 28526249Bonuck 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.
- BackgroundBrooke 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
- BackgroundDriscoll 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.
- BackgroundLouie 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
- BackgroundMorawska 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: PubMed 11145319Owens 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.
- Background: PubMed 23955254Sanders 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.
- BackgroundZelman JJ, Ferro MA. The Parental Stress Scale: Psychometric properties in families of children with chronic health conditions. Family Relations. 2018; 67(2): 240-252.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Smith, Ph.D. principal investigator
Oregon Research Behavioral Interventions Strategies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Talk Parenting Skill for Alexa in people with Parenting Practices and Self Efficacy, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting and Family Adjustment Scales (PAFAS): Positive Encouragement Subscale (time frame: Baseline (T1), 4 weeks after baseline (T2)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04633434, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.