Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05535387
Other study ID # MH124577
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 11, 2024
Est. completion date June 29, 2024

Study information

Verified date April 2024
Source Oregon Research Behavioral Intervention Strategies, Inc.
Contact David R. Smith, PhD
Phone 541-484-2123
Email david.smith@influentsin.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date June 29, 2024
Est. primary completion date June 8, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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. 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.

Locations

Country Name City State
United States Oregon Research Behavioral Intervention Strategies, Inc. Springfield Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Research Behavioral Intervention Strategies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Parent Daily Report of Child Behavior 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)
Primary Strengths and Difficulties Questionnaire Change in parents' reports of child behavior from pre-intervention to post-intervention 4-6 weeks later. Screening (Months 9-11)
Primary Strengths and Difficulties Questionnaire Change in parents' reports of child behavior from pre-intervention to post-intervention 4-6 weeks later. Baseline (T1 - Months 12-15)
Primary Strengths and Difficulties Questionnaire Change in parents' reports of child behavior from pre-intervention to post-intervention 4-6 weeks later. Post-treatment (T2 -Months 13-17)
Primary Intervention Attitude Inventory Parents' reports of acceptability and satisfaction with the FamilyNet system, gathered at post-treatment. Post-treatment (T2 -Months 13-17)
Primary System Usability Scale Parents perceptions of FamilyNet program usability, gathered at post-treatment. Post-treatment (T2 -Months 13-17)
Secondary 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. Baseline (T1 - Months 12-15)
Secondary 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. Post-treatment (T2 -Months 13-17)
Secondary Families' usage of FamilyNet 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)
See also
  Status Clinical Trial Phase
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Withdrawn NCT02247986 - Investigating the Impact of Methylphenidate on Neural Response in Disruptive Behavioral Disorder Phase 1/Phase 2
Recruiting NCT04631042 - Developing Brain, Impulsivity and Compulsivity
Completed NCT02485587 - Arousal-Biofeedback for the Treatment of Aggressive Behavior in Children and Adolescents N/A
Completed NCT00819429 - Supplements and Social Skills Intervention Study N/A
Completed NCT00626236 - Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems Phase 2
Completed NCT01085305 - The Effectiveness of Parent-Child Interaction Therapy (PCIT) N/A
Completed NCT00250354 - A Study of the Safety and Effectiveness of Risperidone for the Treatment of Conduct Disorder and Other Disruptive Behavior Disorders in Children Ages 5 to 12 With Mild, Moderate, or Borderline Mental Retardation Phase 3
Completed NCT00000385 - Long-Term Lithium Treatment for Aggressive Conduct Disorder Phase 3
Withdrawn NCT01443949 - Teenagers, Drug Addiction, and Reward and Impulse Control
Completed NCT04091633 - School Health Implementation Network: Eastern Mediterranean N/A
Completed NCT02563145 - Real-time fMRI for the Treatment of Aggressive Behavior in Adolescents N/A
Completed NCT02766101 - Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges N/A
Completed NCT00404911 - Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth N/A
Completed NCT00051727 - Prevention of School Dropout for Mexican American Adolescents Phase 2
Completed NCT02998073 - Investigating Psychosocial Intervention Treatment Response in Justice-Involved Youth With Conduct Disorder N/A
Completed NCT03292848 - Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders Phase 1
Recruiting NCT06373484 - Matching Assessment and Treatment for Children With Disruptive Behaviour and Their Parents N/A
Recruiting NCT05637320 - Big Feelings: A Study on Children's Emotions in Therapy N/A