- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05535387
Integrated Smart Speaker Promoting Positive Parenting Among Caregivers of Youth With Challenging Behaviors (FamilyNet)
Integrated Smart Speaker/Mobile Application to Promote Positive Parenting Among Caregivers of Youth With Challenging Behaviors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project will develop and establish feasibility of an integrated smart speaker and mobile/web application, FamilyNet, designed to help parents utilize best practices in behavioral parent training to create and implement personalized behavior plans for their children. The FamilyNet system will integrate mobile app, smart speaker technology, and website technologies to assist families in creating their behavior plan, and then will track compliance, timelines, incentives, and other details to assist parents in following through and maintaining the behavior change program that they have created. After development, the intervention program will be pilot-tested with 35 families of youth ages 12-15 with challenging behaviors.
Primary parents will complete measures of parenting practices and child behavior prior to using the FamilyNet system, and again after having access to the program for 4-6 weeks. During the intervention period, user information will be tracked. Post-intervention measures will also include primary parents' perceptions of usability and acceptability of and satisfaction with the FamilyNet system. Children and second parents will also complete satisfaction questionnaires at the post- intervention assessment. Data will be analyzed to determine the degree to which families are able to utilize the FamilyNet interface and report finding it helpful.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David R. Smith, PhD
- Phone Number: 541-484-2123
- Email: David.Smith@influentsin.com
Study Contact Backup
- Name: Edward G. Feil, PhD
- Phone Number: 541-484-2123
- Email: ed@ori.org
Study Locations
-
-
Oregon
-
Springfield, Oregon, United States, 97477
- Recruiting
- Oregon Research Behavioral Intervention Strategies, Inc.
-
Contact:
- David R Smith, PhD
- Phone Number: 541-484-2123
- Email: David.Smith@influentsin.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Primary parent/caregiver who has a child ages 12- to 15-years-old who lives with them at least half the time;
- Client of and referred to the study by partner family treatment services sites in Lane County, Oregon;
- Has a smartphone and access to email;
- Speaks English;
- The target child has a Strength & Difficulties Questionnaire total score or 14 or greater (top 20th percentile).
Exclusion criteria:
- The target-age child has a developmental disability severe enough that the child is unable to speak and/or follow simple directions;
- The parent is in active treatment for serious mental illness or serious addiction;
- The family is homeless.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FamilyNet smart speaker/mobile application
In a 4- to 6-week period, families will use a prototype of the FamilyNet integrated and coordinated smart speaker/mobile application designed to provide families with in-situ experiential support for building positive behavior plans.
|
In a 4- to 6-week period, families will use a prototype of the FamilyNet integrated and coordinated smart speaker/mobile application designed to provide families with in-situ experiential support for building positive behavior plans.
The prototype FamilyNet program will guide families in creating and implementing positive behavior plans to foster positive child behavior, consistent parenting, and promote a positive parent-child relationship.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strengths and Difficulties Questionnaire
Time Frame: Screening (Months 9-11)
|
Change in parents' reports of child behavior from pre-intervention to post-intervention 4-6 weeks later.
|
Screening (Months 9-11)
|
Strengths and Difficulties Questionnaire
Time Frame: Baseline (T1 - Months 12-15)
|
Change in parents' reports of child behavior from pre-intervention to post-intervention 4-6 weeks later.
|
Baseline (T1 - Months 12-15)
|
Strengths and Difficulties Questionnaire
Time Frame: Post-treatment (T2 -Months 13-17)
|
Change in parents' reports of child behavior from pre-intervention to post-intervention 4-6 weeks later.
|
Post-treatment (T2 -Months 13-17)
|
Intervention Attitude Inventory
Time Frame: Post-treatment (T2 -Months 13-17)
|
Parents' reports of acceptability and satisfaction with the FamilyNet system, gathered at post-treatment.
|
Post-treatment (T2 -Months 13-17)
|
System Usability Scale
Time Frame: Post-treatment (T2 -Months 13-17)
|
Parents perceptions of FamilyNet program usability, gathered at post-treatment.
|
Post-treatment (T2 -Months 13-17)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adult-Adolescent Parenting Inventory 2
Time Frame: Baseline (T1 - Months 12-15)
|
Change in parents' reports of their parenting and child-rearing attitudes from pre-intervention to post-intervention 4-6 weeks later.
|
Baseline (T1 - Months 12-15)
|
Adult-Adolescent Parenting Inventory 2
Time Frame: Post-treatment (T2 -Months 13-17)
|
Change in parents' reports of their parenting and child-rearing attitudes from pre-intervention to post-intervention 4-6 weeks later.
|
Post-treatment (T2 -Months 13-17)
|
Families' usage of FamilyNet
Time Frame: During active intervention use (Months 12-17)
|
Families' usage of the FamilyNet program will be measured through usage metrics and transcripts collected on the back-end database.
|
During active intervention use (Months 12-17)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent Daily Report of Child Behavior
Time Frame: During active intervention use (Months 12-17)
|
Parents' reports of child behavior will be obtained 3-5 times weekly via the mobile app, in which parents answer questions about the type of child problem behaviors that have occurred over the last 24 hours.
|
During active intervention use (Months 12-17)
|
Collaborators and Investigators
Investigators
- Principal Investigator: David R. Smith, PhD, Oregon Research Behavioral Intervention Strategies, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH124577
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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