NCT06184243

Brief Summary

The goal of this clinical trial is to learn about how parent training can be used to teach a social skills intervention for their young child with developmental delays. Video modeling is a type of technology based intervention that teaches new skills using videos of someone acting out the behavior. The main questions it aims to answer are:

  • How well do the parent training procedures teach parents all the steps for using video modeling as a social skills intervention?
  • Do the children with developmental delays play and communicate more with their parents after the parent uses video modeling as a social skills intervention? Parent participants will be asked to participate in 3 interviews 30 min to 1 hour each, 2 in-home sessions 1 ½ to 2 hours each, 30 min Zoom sessions 2-3 times per week for 2-5 months Child participants will participate in 2 in-home sessions 1 ½ to 2 hours each and 30 min Zoom sessions 2-3 times per week for 2-5 months The time commitment is in ideal conditions, but will be impacted by other participants and parent schedules. The family will be committing to approximately 2-5 hours per week for 2-5 months. Sessions may occur as few as 0 or as many as 5 times per week. The hypothesis is that the parent training will teach parents all the steps to use video modeling intervention in their home with their young child with a disability. The second hypothesis is that the child with a disability will learn new social skills to play and communicate better in their home with their parent after watching the video models.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 1, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 28, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

December 4, 2023

Last Update Submit

December 14, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Parent: Implementation Fidelity

    For parent behavior, the dependent variable that will be measured will be the percentage of implementation fidelity based on the procedural checklist for the intervention. The parent will implement the intervention and conduct play sessions. The checklist includes how the parents will set up the physical environment for viewing the video and for play sessions. The parent will follow a guide for parent-child interaction to control for variables like prompting.

    Implementation fidelity data will be collected for 5 minutes during a session, 2-3 times per week for 2 to 5 months in ideal conditions. To adjust for parent schedules and commitments, as few as 0 to as many as 5 sessions per week may be conducted.

  • Child: Scripted Play Actions

    For child behavior, frequency of scripted play actions will be measured. Scripted play actions defined as motor movements with or without materials in the play area that make sense within the context of play and portrayed in the video model. Frequency data will be collected for 5 minutes. Stereotyped movements will not be recorded in the frequency.

    Scripted play action data will be collected for 5 minutes during a session, 2-3 times per week for 2 to 5 months in ideal conditions. To adjust for parent schedules and commitments, as few as 0 to as many as 5 sessions per week may be conducted.

  • Child: Unscripted Play Actions

    For child behavior, frequency of scripted play actions will be measured. For child behavior, frequency of unscripted play actions will be measured. Unscripted play actions defined as motor movements with or without materials in the play area that make sense within the context of play and are not portrayed in the video model. Frequency data will be collected for 5 minutes. Stereotyped movements will not be recorded in the frequency.

    Unscripted play action data will be collected for 5 minutes during a session, 2-3 times per week for 2 to 5 months in ideal conditions. To adjust for parent schedules and commitments, as few as 0 to as many as 5 sessions per week may be conducted.

  • Child: Scripted Vocalizations

    For child behavior, frequency of scripted vocalizations will be measured. Scripted vocalizations defined as words, short phrases, and play sounds (e.g. "vroom", "whoosh") that make sense in the context of play and portrayed in the video model. Frequency data will be collected for 5 minutes. Repetitive sounds or words will only be recorded once.

    Scripted vocalization data will be collected for 5 minutes during a session, 2-3 times per week for 2 to 5 months in ideal conditions. To adjust for parent schedules and commitments, as few as 0 to as many as 5 sessions per week may be conducted.

  • Child: Unscripted Vocalizations

    For child behavior, frequency of unscripted vocalizations will be measured. Unscripted vocalizations defined as words, short phrases, and play sounds (e.g. "vroom", "whoosh") that make sense in the context of play and are not portrayed in the video model. Frequency data will be collected for 5 minutes. Repetitive sounds or words will only be recorded once.

    Unscripted vocalization data will be collected for 5 minutes during a session, 2-3 times per week for 2 to 5 months in ideal conditions. To adjust for parent schedules and commitments, as few as 0 to as many as 5 sessions per week may be conducted.

Study Arms (1)

Parent-Implemented Video Modeling

EXPERIMENTAL

Parent intervention teaches the skills to implement video modeling intervention for their young child with a developmental delay. Video modeling intervention teaches the young child new play and conversation skills.

Behavioral: Parent TrainingBehavioral: Video Modeling

Interventions

Parent TrainingBEHAVIORAL

Parent training will cover the topic of creating social skills, goal setting, creating a video model, how to implement the video model intervention, and the parent-child interaction procedures during play. Parents will learn the steps in the fidelity checklist and demonstrate the steps at 90% proficiency by the end of the training. Parent coaching will continue before and after child intervention sessions.

Parent-Implemented Video Modeling
Video ModelingBEHAVIORAL

The child will be recorded for a video model engaging in play at their home. The videos will be created with the parent and researcher in the home. A video using the same materials in the same location will be created depicting the child in a play scenario. The video will be two-to-three minutes in length. Each child will receive at least three sessions of intervention and no more than five sessions of intervention per week.

Parent-Implemented Video Modeling

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parent
  • English speaking
  • Must to participate in in-home parent training, willing to participate in video interviews, willing to participate in video recorded play sessions
  • Only one parent in the home will participate
  • At least 18 years old and able to consent to participate in study
  • Child
  • between the ages 3 and 5.5
  • have a developmental delay as defined by Individuals with Disability Education Act
  • demonstrate a need for social skills intervention with ASQ:SE-2 scoring below cutoff or in the monitoring zone.
  • shows the ability to use 1 to 2-word phrases
  • imitates 10 actions and 10 words
  • attends to a video for 3 minutes

You may not qualify if:

  • English is not a primary language spoken at home
  • the home is unsafe (Defined as violence witnessed in the home, drug or alcohol use while researcher is in the home, and non-service animals in the intervention area.)
  • the child does not display minimum levels of language (e.g., 1 to 2 word phrases), imitation (e.g., 10 gestures 10 words) and/or attention (e.g., 3 minutes attending to a screen)
  • the child does not show social skills delays ASQ:SE-2 scoring above the cutoff.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

RECRUITING

Related Publications (3)

  • Cooper, J. 0., Heron, T. E., & Heward, W. L. (2020). Applied behavior analysis (3rd edition). Pearson: Hoboken, NJ.

    BACKGROUND
  • Squires, J. & Bricker, D. (2009). Ages & Stages Questionnaires®, (3rd ed., ASQ®-3): A parent-completed child monitoring system. Paul H. Brookes Publishing Co., Inc.

    BACKGROUND
  • Squires, J., Bricker, D., & Twombly, E. (2015) Ages & Stages Questionnaires®: Social-emotional (2nd ed., ASQ®:SE-2): A parent-completed child monitoring system for social-emotional behaviors. Paul H. Brookes Publishing Co., Inc.

    BACKGROUND

MeSH Terms

Conditions

Learning DisabilitiesSocial Skills

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Alain Bengochea, PhD

    University of Nevada, Las Vegas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Morgan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study will be a single subject design which will be replicated across multiple participants. The participants are pairs of one parent and one child for each session. The participants will be observed during the initial baseline phase before the intervention. The baseline phase will be used to compare the initial abilities before the intervention of the participants to their abilities after the intervention. After the baseline, the parent will participate in a parent training on how to use video modeling intervention with their child. Then the intervention phase begins. The parent and child will watch the video created to show new play skills for the child together and then have a play session. The parent will receive coaching before and after sessions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 28, 2023

Study Start

December 1, 2023

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

December 28, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations