Clinical trial NCT04633434: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parenting Practices
Self Efficacy
Stress
Child Behavior
Emotional Adjustment
Sleep Problems
Parent-Child Relations
Keywords: Feasibility
Satisfaction
Usability
Lead sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-11-18
Enrollment: 98
Sex: ALL
Minimum age (years): 3
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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

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

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

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Parenting and Family Adjustment Scales (PAFAS): Positive Encouragement Subscale
timeFrame: Baseline (T1), 4 weeks after baseline (T2)
measure: Parenting and Family Adjustment Scales (PAFAS) - Coercive Parenting Subscale
timeFrame: Baseline (T1), 4 weeks after baseline (T2)
measure: Child Adjustment and Parent Self-Efficacy Scale (CAPES) - Emotional Adjustment Subscale
timeFrame: Baseline (T1), 4 weeks after baseline (T2)
measure: Child Adjustment and Parent Self-Efficacy Scale (CAPES) - Behavior Problems Subscale
timeFrame: Baseline (T1), 4 weeks after baseline (T2)
measure: Short-Form Children's Sleep Habits Questionnaire (SF-CSHQ)
timeFrame: Baseline (T1), 4 weeks after baseline (T2)
measure: Program-Targeted Parenting Practices - Frequency of Engagement Subscale
timeFrame: Baseline (T1), 4 weeks after baseline (T2)
measure: Program-Targeted Parenting Practices - Self-Efficacy of Practice Subscale
timeFrame: Baseline (T1), 4 weeks after baseline (T2)
measure: Program-Targeted Parenting Practices - Satisfaction Handling Bedtime Subscale
timeFrame: Baseline (T1), 4 weeks after baseline (T2)
measure: Child-Parent Relationship Scale - Short Form (CPRS) - Closeness Subscale
timeFrame: Baseline (T1), 4 weeks after baseline (T2)
measure: Child-Parent Relationship Scale - Short Form (CPRS) - Parent-Child Conflict Subscale
timeFrame: Baseline (T1), 4 weeks after baseline (T2)
measure: System Usability Scale (SUS)
timeFrame: At 4 weeks after baseline (T2)
measure: Program Acceptability
timeFrame: At 4 weeks after baseline (T2)
Secondary outcomes:
measure: Self-Efficacy for Parenting Tasks Index (SEPTI) - Toddler Scale - Discipline Subscale
timeFrame: Baseline (T1), 4 weeks after baseline (T2)
measure: Self-Efficacy for Parenting Tasks Index (SEPTI) - Toddler Scale - Routine Subscale
timeFrame: Baseline (T1), 4 weeks after baseline (T2)
measure: Parental Stress Scale (PSS)
timeFrame: Baseline (T1), 4 weeks after baseline (T2)
measure: Families' Usage of the Talk Parenting (TP) Skill - Number of Families That Activated the Skill
timeFrame: At 4 weeks after baseline (T2)
measure: Families' Usage of the Talk Parenting (TP) Skill - Number of Times Skill Was Used
timeFrame: At 4 weeks after baseline (T2)
measure: Families' Usage of the Talk Parenting (TP) Skill - Number of Steps Used
timeFrame: At 4 weeks after baseline (T2)
measure: Families' Usage of the Talk Parenting (TP) Skill - Length of Bedtime Routine
timeFrame: At 4 weeks after baseline (T2)
measure: Families' Usage of the Talk Parenting (TP) Skill - Listened to a Podcast
timeFrame: At 4 weeks after baseline (T2)
Other outcomes:
Locations:
city: Eugene
country: United States
facility: David R Smith
state: Oregon
Study officials:
affiliation: Oregon Research Behavioral Interventions Strategies, Inc.
name: David R Smith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
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
citation: 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.
citation: 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
citation: 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.
citation: 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.
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.
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.