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Integrated Smart Speaker Promoting Positive Parenting Among Caregivers of Youth With Challenging Behaviors (FamilyNet)

Primary Purpose

Oppositional Defiant Disorder, Conduct Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FamilyNet smart speaker/mobile application
Sponsored by
Oregon Research Behavioral Intervention Strategies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oppositional Defiant Disorder

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  1. Primary parent/caregiver who has a child ages 12- to 15-years-old who lives with them at least half the time;
  2. Client of and referred to the study by partner family treatment services sites in Lane County, Oregon;
  3. Has a smartphone and access to email;
  4. Speaks English;
  5. The target child has a Strength & Difficulties Questionnaire total score or 14 or greater (top 20th percentile).

Exclusion criteria:

  1. The target-age child has a developmental disability severe enough that the child is unable to speak and/or follow simple directions;
  2. The parent is in active treatment for serious mental illness or serious addiction;
  3. The family is homeless.

Sites / Locations

  • Oregon Research Behavioral Intervention Strategies, Inc.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FamilyNet smart speaker/mobile application

Arm Description

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.

Outcomes

Primary Outcome Measures

Strengths and Difficulties Questionnaire
Change in parents' reports of child behavior from pre-intervention to post-intervention 4-6 weeks later.
Strengths and Difficulties Questionnaire
Change in parents' reports of child behavior from pre-intervention to post-intervention 4-6 weeks later.
Strengths and Difficulties Questionnaire
Change in parents' reports of child behavior from pre-intervention to post-intervention 4-6 weeks later.
Intervention Attitude Inventory
Parents' reports of acceptability and satisfaction with the FamilyNet system, gathered at post-treatment.
System Usability Scale
Parents perceptions of FamilyNet program usability, gathered at post-treatment.

Secondary Outcome Measures

Adult-Adolescent Parenting Inventory 2
Change in parents' reports of their parenting and child-rearing attitudes from pre-intervention to post-intervention 4-6 weeks later.
Adult-Adolescent Parenting Inventory 2
Change in parents' reports of their parenting and child-rearing attitudes from pre-intervention to post-intervention 4-6 weeks later.
Families' usage of FamilyNet
Families' usage of the FamilyNet program will be measured through usage metrics and transcripts collected on the back-end database.

Full Information

First Posted
February 7, 2022
Last Updated
August 10, 2023
Sponsor
Oregon Research Behavioral Intervention Strategies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05535387
Brief Title
Integrated Smart Speaker Promoting Positive Parenting Among Caregivers of Youth With Challenging Behaviors
Acronym
FamilyNet
Official Title
Integrated Smart Speaker/Mobile Application to Promote Positive Parenting Among Caregivers of Youth With Challenging Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
March 8, 2024 (Anticipated)
Study Completion Date
March 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Behavioral Intervention Strategies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This project will develop and evaluate the feasibility of an integrated smart speaker and mobile/web-based application, "FamilyNet" (FN) to assist parents in implementing empirically supported behavioral parenting strategies to promote positive behavior change in their children. The FamilyNet system will help parents to create a positively framed, individualized behavioral plan for their child(ren), and then provide prompts, reminders, and tracking tools to help them effectively implement that plan. Once developed, FamilyNet will be field tested for usability and usefulness with a group of parents who have children ages 12-15 years exhibiting challenging behaviors. Establishing feasibility of this innovative parenting tool will have important implications for harnessing smart speaker and mobile/web technologies to provide parents in-situ support with parenting challenges; parents' effective implementation of empirically supported parenting strategies is likely to increase children's prosocial behaviors and reduce problematic behaviors, thus reducing their risk for long-term behavioral problems.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oppositional Defiant Disorder, Conduct Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FamilyNet smart speaker/mobile application
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
FamilyNet smart speaker/mobile application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Strengths and Difficulties Questionnaire
Description
Change in parents' reports of child behavior from pre-intervention to post-intervention 4-6 weeks later.
Time Frame
Screening (Months 9-11)
Title
Strengths and Difficulties Questionnaire
Description
Change in parents' reports of child behavior from pre-intervention to post-intervention 4-6 weeks later.
Time Frame
Baseline (T1 - Months 12-15)
Title
Strengths and Difficulties Questionnaire
Description
Change in parents' reports of child behavior from pre-intervention to post-intervention 4-6 weeks later.
Time Frame
Post-treatment (T2 -Months 13-17)
Title
Intervention Attitude Inventory
Description
Parents' reports of acceptability and satisfaction with the FamilyNet system, gathered at post-treatment.
Time Frame
Post-treatment (T2 -Months 13-17)
Title
System Usability Scale
Description
Parents perceptions of FamilyNet program usability, gathered at post-treatment.
Time Frame
Post-treatment (T2 -Months 13-17)
Secondary Outcome Measure Information:
Title
Adult-Adolescent Parenting Inventory 2
Description
Change in parents' reports of their parenting and child-rearing attitudes from pre-intervention to post-intervention 4-6 weeks later.
Time Frame
Baseline (T1 - Months 12-15)
Title
Adult-Adolescent Parenting Inventory 2
Description
Change in parents' reports of their parenting and child-rearing attitudes from pre-intervention to post-intervention 4-6 weeks later.
Time Frame
Post-treatment (T2 -Months 13-17)
Title
Families' usage of FamilyNet
Description
Families' usage of the FamilyNet program will be measured through usage metrics and transcripts collected on the back-end database.
Time Frame
During active intervention use (Months 12-17)
Other Pre-specified Outcome Measures:
Title
Parent Daily Report of Child Behavior
Description
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.
Time Frame
During active intervention use (Months 12-17)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David R. Smith, PhD
Phone
541-484-2123
Email
david.smith@influentsin.com
First Name & Middle Initial & Last Name or Official Title & Degree
Edward G. Feil, PhD
Phone
541-484-2123
Email
ed@ori.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Smith, PhD
Organizational Affiliation
Oregon Research Behavioral Intervention Strategies, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Behavioral Intervention Strategies, Inc.
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David R Smith, PhD
Phone
541-484-2123
Email
David.Smith@influentsin.com

12. IPD Sharing Statement

Learn more about this trial

Integrated Smart Speaker Promoting Positive Parenting Among Caregivers of Youth With Challenging Behaviors

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