NCT05287685

Brief Summary

This project is a study funded by the National Institute of Child Health and Human Development to develop and pilot test an adapted parenting intervention to decrease excessive/inappropriate screen media use in young children with externalizing behavior problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

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 22, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 28, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 15, 2024

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

1.6 years

First QC Date

February 22, 2022

Results QC Date

October 17, 2024

Last Update Submit

November 12, 2024

Conditions

Keywords

child screen media use; behavior; parenting

Outcome Measures

Primary Outcomes (5)

  • Child Screen Media Use (Time)

    Child screen media use will be measured with parent-reported data on screen use duration (including TV and other screen devices) and content. The outcome variable will be total screen use per weekend day.

    Change from baseline (week 0) to posttest (week 8) and follow-up (week 16)

  • Child Screen Media Use (Proportion Educational)

    The proportion of child screen media use that parents report is educational.

    Change from baseline (week 0) to posttest (week 8) and follow-up (week 16)

  • Treatment Attitude Inventory (TAI)

    The TAI is a parent-report measure that assesses parent satisfaction with treatment. Test-retest reliability over 4 months and correlations between the TAI and both parent-rating scales and observational measures of treatment change have been demonstrated. The TAI total score will be administered to assess parent satisfaction with the intervention. The minimum value is 0 and the maximum is 50, with higher scores indicating better satisfaction.

    Posttest (Week 8)

  • Perceived Parental Efficacy Scale

    Parents' perceived efficacy in managing children's screen time will be assessed using the Perceived Parental Efficacy subscale of the Parent Perceptions of Technology Scale (PPTS), which assesses parents' self-efficacy in using electronic media and managing children's screen time (e.g., "I won't bother setting parental controls or passwords because my kids will "hack" around them."). The 5 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Items were reverse scored and averaged to create the overall scale score, with higher scores meaning better perceived efficacy.

    Change from baseline (week 0) to posttest (week 8) and follow-up (week 16).

  • Technology-related Parenting Scale

    The Technology-related Parenting Scale is an 8-item self-report survey assessing parents' use of rules (e.g., "I set limits on the amount of time") and enforcement strategies ("I use passwords on these devices") for children's technology use on a 3-point scale from 0 (not true) to 2 (very true). Items will be averaged to create an overall score, with higher scores meaning more limit setting.

    Change from baseline (week 0) to posttest (week 8) and follow-up (week 16)

Study Arms (2)

Screen media adapted School Readiness Parenting Program

EXPERIMENTAL

Screen media adapted School Readiness Parenting Program (Once weekly session of 1.5 hours for 8 weeks)

Behavioral: Screen media adapted School Readiness Parenting Program

Original School Readiness Parenting Program

ACTIVE COMPARATOR

Original School Readiness Parenting Program (Once weekly session of 1.5 hours for 8 weeks)

Behavioral: School Readiness Parenting Program

Interventions

For the screen time adapted parenting intervention, screen time intervention components will be infused into the SRPP (described below) to address three primary areas shown in research to play an important role in healthy screen media use: (1) reducing and managing screen time use; (2) maximizing benefits of screen time content; and (3) promoting positive parent-child interactions during co-use of screen media. Psychoeducation and practice of these strategies will be incorporated into sessions of the SRPP in which relevant behavioral concepts are addressed.The screen time adapted parenting intervention will utilize the same format (large group, 8 weekly 1.5 hour sessions) as the SRPP.

Screen media adapted School Readiness Parenting Program

The SRPP is an 8-week parenting program for parents of preschool aged children with externalizing behavior problems. The SRPP targets child externalizing behavior problems specifically, as well as to help parents promote children's school readiness skills. The SRPP follows a group Parent-Child Interaction Therapy (PCIT) model and also uses motivational interviewing and modelling problem solving approaches. The SRPP utilizes a large group format (10-15 parents) with weekly sessions lasting 1.5 hours. The SRPP curriculum contains traditional aspects of behavioral management strategies (e.g., improving parenting skills and the parent-child relationship; discipline strategies such as time out). Specific sessions of the SRPP also directly target parental interactions during children's learning activities and setting up homework and household structure and routines. In its original form, SRPP does not address children's screen time.

Original School Readiness Parenting Program

Eligibility Criteria

Age54 Months - 66 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • eligible child who is 54 to 66 months old at Spring intake (i.e. will be entering Kindergarten after the summer)
  • parent-reported externalizing behavior problems on the Kiddie-Disruptive Behavior Disorder Schedule (parent report) or the Disruptive Behavior Disorder Rating Scale (teacher report) that meet criteria for a disruptive behavior disorder diagnosis
  • child general cognitive ability score 70 or above on the Differential Abilities Scales-II, - caregiver willing and able to attend weekly parent groups conducted in English.

You may not qualify if:

  • Families with children with major sensory impairments (e.g., deafness, blindness) or severe problems that impair mobility (e.g., cerebral palsy)are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Mental DisordersBehavior

Results Point of Contact

Title
Shayl Griffith, PhD
Organization
Florida International University

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Teachers rating behavior and independent coders assessing parent-child interactions will be masked to condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2022

First Posted

March 18, 2022

Study Start

April 28, 2022

Primary Completion

November 28, 2023

Study Completion

November 28, 2023

Last Updated

November 15, 2024

Results First Posted

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

A controlled access approach, using a robust system to review requests and provide secure access to de-identified data, will be utilized.

Shared Documents
STUDY PROTOCOL
Time Frame
Deidentified data for the entire database will be made available for data sharing after the main findings from the final dataset have been accepted for publication.
Access Criteria
Users will be provided with the data under a data-sharing agreement which specifies that: (1) data will be used only for research purposes; (2) data will be stored confidentially and securely; and (3) data will be destroyed after analyses are completed. PI Bagner and collaborators will identify where the data will be available and how to access the data in any publications and presentations using these data.

Locations