NCT05535387

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 10-17 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

February 7, 2022

Last Update Submit

April 29, 2025

Conditions

Outcome Measures

Primary Outcomes (11)

  • Strengths and Difficulties Questionnaire 11-17 - Emotional Problems Subscale

    Strengths and Difficulties Questionnaire 4-17 (SDQ; Goodman, 1997) is used to measure the child's overall adjustment. The SDQ is a brief, valid, reliable, and commonly used parent-report questionnaire about child behavior. The instrument includes 25 items that assess child challenging behaviors (emotional symptoms, conduct problems, hyperactivity/inattention), peer relationships, and prosocial behavior, with 5 items measuring each subscale. Respondents answer on a 3-point scale from 0 to 2 (0 = "Not true;" 2 = "Certainly true"). For the Emotional Problems Subscale, scores for the 5 items are summed together; the subscale score can range from 0 to 10. Higher scores indicate worse adjustment (worse outcome).

    Baseline (T1), 4 weeks after baseline (T2)

  • Strengths and Difficulties Questionnaire 11-17 - Conduct Problems Subscale

    Strengths and Difficulties Questionnaire 4-17 (SDQ; Goodman, 1997) is used to measure the child's overall adjustment. The SDQ is a brief, valid, reliable, and commonly used parent-report questionnaire about child behavior. The instrument includes 25 items that assess child challenging behaviors (emotional symptoms, conduct problems, hyperactivity/inattention), peer relationships, and prosocial behavior, with 5 items measuring each subscale. Respondents answer on a 3-point scale from 0 to 2 (0 = "Not true;" 2 = "Certainly true"). For the Conduct Problems Subscale, scores for the 5 items are summed together; the subscale score can range from 0 to 10. Higher scores indicate worse adjustment (worse outcome).

    Baseline (T1), 4 weeks after baseline (T2)

  • Strengths and Difficulties Questionnaire 11-17 - Hyperactivity Subscale

    Strengths and Difficulties Questionnaire 4-17 (SDQ; Goodman, 1997) is used to measure the child's overall adjustment. The SDQ is a brief, valid, reliable, and commonly used parent-report questionnaire about child behavior. The instrument includes 25 items that assess child challenging behaviors (emotional symptoms, conduct problems, hyperactivity/inattention), peer relationships, and prosocial behavior, with 5 items measuring each subscale. Respondents answer on a 3-point scale from 0 to 2 (0 = "Not true;" 2 = "Certainly true"). For the Hyperactivity Subscale, scores for the 5 items are summed together; the subscale score can range from 0 to 10. Higher scores indicate worse adjustment (worse outcome).

    Time Frame: Baseline (T1), 4 weeks after baseline (T2)

  • Strengths and Difficulties Questionnaire 11-17 - Peer Problems Subscale

    Strengths and Difficulties Questionnaire 4-17 (SDQ; Goodman, 1997) is used to measure the child's overall adjustment. The SDQ is a brief, valid, reliable, and commonly used parent-report questionnaire about child behavior. The instrument includes 25 items that assess child challenging behaviors (emotional symptoms, conduct problems, hyperactivity/inattention), peer relationships, and prosocial behavior, with 5 items measuring each subscale. Respondents answer on a 3-point scale from 0 to 2 (0 = "Not true;" 2 = "Certainly true"). For the Peer Problems Subscale, scores for the 5 items are summed together; the subscale score can range from 0 to 10. Higher scores indicate worse adjustment (worse outcome).

    Baseline (T1), 4 weeks after baseline (T2)

  • Strengths and Difficulties Questionnaire 11-17 - Prosocial Subscale

    Strengths and Difficulties Questionnaire 4-17 (SDQ; Goodman, 1997) is used to measure the child's overall adjustment. The SDQ is a brief, valid, reliable, and commonly used parent-report questionnaire about child behavior. The instrument includes 25 items that assess child challenging behaviors (emotional symptoms, conduct problems, hyperactivity/inattention), peer relationships, and prosocial behavior, with 5 items measuring each subscale. Respondents answer on a 3-point scale from 0 to 2 (0 = "Not true;" 2 = "Certainly true"). For the Prosocial Subscale, scores for the 5 items are summed together; the subscale score can range from 0 to 10. Higher scores indicate better adjustment (better outcome).

    Baseline (T1), 4 weeks after baseline (T2)

  • Strengths and Difficulties Questionnaire 11-17 - Total Difficulties Score

    Strengths and Difficulties Questionnaire 4-17 (SDQ; Goodman, 1997) is used to measure the child's overall adjustment. The SDQ is a brief, valid, reliable, and commonly used parent-report questionnaire about child behavior. The instrument includes 25 items that assess child challenging behaviors (emotional symptoms, conduct problems, hyperactivity/inattention), peer relationships, and prosocial behavior, with 5 items measuring each subscale. Respondents answer on a 3-point scale from 0 to 2 (0 = "Not true;" 2 = "Certainly true"). For the Total Difficulties Score, subscale scores for the Emotional Problems, Conduct Problems, Hyperactivity, and Peer Problems items are summed together; the Total Difficulties score can range from 0 to 40. Higher scores indicate worse adjustment (worse outcome).

    Baseline (T1), 4 weeks after baseline (T2)

  • Program Acceptability - Parent Perception of Improvement

    Measure Description: Parents' perceptions of improvement in their child's behavior was measured with 4 items of the Program Acceptability - Parent Perception of Improvement Subscale measure at T2, 4 weeks after baseline. Parents indicate their perceptions of recent change in their child's positive behavior and their relationship with their child. Respondents answer items on a 5-point scale (e.g. 1 = Considerably worse; 5 = Greatly improved). Scores on these 4 items are averaged together; subscale scores range from 1 to 5. Higher scores indicate parent perceptions of more improvement (better outcome).

    At 4 weeks after baseline (T2)

  • Program Acceptability - Parent Satisfaction Subscale - Parent Report

    Parent Satisfaction was measured with 10 items of the Program Acceptability - Parent Satisfaction Subscale measure at T2, 4 weeks after baseline, asking the extent to which parents found that the FamilyNet program was helpful, enjoyable, addressed important issues, helped them follow through on their behavior change plan, helped them manage their child's behavior more effectively, was the type of help they wanted, and their overall satisfaction with the program. Respondents answer items on a 7-point scale (e.g. 1 = Not at all; 7 = Very much). Scores on these 10 items are averaged together; subscale scores range from 1 to 7. Higher scores indicate better parent satisfaction.

    At 4 weeks after baseline (T2)

  • Program Acceptability - Child Satisfaction Subscale - Child Report

    Child Satisfaction was measured with 5 items of the Program Acceptability - Child Satisfaction Subscale measure at post-treatment, asking the extent to which the child found that the FamilyNet program was helpful and enjoyable, and their overall satisfaction with the program. Respondents answer items on a 7-point scale (e.g. 1 = Not at all; 7 = Very much). Scores on these 5 items are averaged together; subscale scores range from 1 to 7. Higher scores indicate better child satisfaction.

    At 4 weeks after baseline (T2)

  • System Usability Scale - Parent Report

    Parents' perceptions of the usability of the FamilyNet program 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 (0=Strongly disagree; 4=Strongly agree); scores on the scale are summed and multiplied by 2.5, such that they range from 0 to 100, with higher scores indicating better usability. The SUS has been normed, and scoring produces an overall usability "grade" (Brooke, 1996; Sauro, 2011). This measure is obtained from the parents at post-test.

    At 4 weeks after baseline (T2)

  • System Usability Scale - Child Report

    Child perceptions of the usability of the FamilyNet program 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 (0=Strongly disagree; 4=Strongly agree); scores on the scale are summed and multiplied by 2.5, such that they range from 0 to 100, with higher scores indicating better usability (better outcome). The SUS has been normed, and scoring produces an overall usability "grade" (Brooke, 1996; Sauro, 2011). This measure is obtained from the youth at post-test.

    At 4 weeks after baseline (T2)

Secondary Outcomes (10)

  • Parenting Practices Inventory - Inconsistent Discipline Subscale

    Baseline (T1), 4 weeks after baseline (T2)

  • Parenting Practices Inventory - Positive Reinforcement Subscale

    Baseline (T1), 4 weeks after baseline (T2)

  • CASY Child-Parent Relationship Scales - Parent-Child Conflict subscale

    Baseline (T1), 4 weeks after baseline (T2)

  • CASY Child-Parent Relationship Scales - Positive Family Relations Subscale

    Baseline (T1), 4 weeks after baseline (T2)

  • Program-Targeted Parenting Practices - Frequency Subscale

    Baseline (T1), 4 weeks after baseline (T2)

  • +5 more secondary outcomes

Study Arms (1)

FamilyNet smart speaker/mobile application

EXPERIMENTAL

In a 4-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.

Behavioral: FamilyNet smart speaker/mobile application

Interventions

In a 4-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.

FamilyNet smart speaker/mobile application

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary parent/caregiver who has a child ages 10- to 17-years-old who lives with them at least half the time
  • Has a smartphone and access to email
  • Speaks English

You may not qualify if:

  • a. The target-age child has a developmental disability severe enough that the child is unable to speak and/or follow simple directions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Behavioral Intervention Strategies, Inc.

Springfield, Oregon, 97477, United States

Location

Related Publications (8)

  • Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.

    PMID: 9255702BACKGROUND
  • Brooke, J. (1996). SUS-A quick and dirty usability scale. In P. W. Jordan, B. Thomas, B. A. Weerdmeester, & I. L. McClelland (Eds.), Usability evaluation in industry (Vol. 189, pp. 169-194). London, UK: Taylor & Francis.

    BACKGROUND
  • Sauro, J. (2011). A practical guide to the system usability scale: Background, benchmarks & best practices. Denver, CO: Measuring Usability LLC.

    BACKGROUND
  • Metzler, C.W., Taylor, T.K., & Foster, E.M. (2006). Associations between specific parental discipline practices and specific dimensions of young children's behavior problems. Unpublished technical report.

    BACKGROUND
  • Metzler, C. W., Biglan, A., Ary, D. V., & Li, F. (1998). The stability and validity of early adolescents' reports of parenting constructs. Journal of Family Psychology, 12(4), 600-619.

    BACKGROUND
  • Prinz RJ, Foster S, Kent RN, O'Leary KD. Multivariate assessment of conflict in distressed and nondistressed mother-adolescent dyads. J Appl Behav Anal. 1979 Winter;12(4):691-700. doi: 10.1901/jaba.1979.12-691.

    PMID: 541311BACKGROUND
  • Moos, R. H., & Moos, B. A. (1986). Manual for the Family Environment Scale. Palo Alto, CA: Consulting Psychologists Press.

    BACKGROUND
  • Chamberlain, P., & Reid, J. B. (1987). Parent observation and report of child symptoms. Behavioral Assessment, 9(1), 97-109.

    BACKGROUND

MeSH Terms

Conditions

Oppositional Defiant DisorderConduct Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • David R. Smith, PhD

    Oregon Research Behavioral Intervention Strategies, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2022

First Posted

September 10, 2022

Study Start

March 11, 2024

Primary Completion

December 15, 2024

Study Completion

December 30, 2024

Last Updated

May 2, 2025

Record last verified: 2025-04

Locations