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Optimizing Outcomes for Young Autistic Children

Primary Purpose

Autism, Autism Spectrum Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Social Communication
Disruptive Behavior
Social Communication + Reduce Frequency
Social Communication + Add Tools
Disruptive Behavior + Reduce Frequency
Disruptive Behavior + Add Tools
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring intervention, early intervention, toddlers, autistic, autism, virtual, tele-health

Eligibility Criteria

18 Months - 48 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Child is between 18 and 48 months old Child scores above the research cutoff for ASD on the TELE-ASD-PEDS Child has no other known diagnosis or disability at study entry Child has normal vision Child is exposed to English at least 50% of the time Child has a caregiver willing to learn the intervention strategies Caregiver wants help supporting their child's social communication and behavior regulation Caregiver understands conversational English well enough to participate in caregiver instruction

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Social Communication + Reduce Frequency

Social Communication + Add Tools

Social Communication + Switch Intervention to Disruptive Behavior

Disruptive Behavior + Reduce Frequency

Disruptive Behavior + Add Tools

Disruptive Behavior + Switch Intervention to Social Communication

Arm Description

Starting Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week Secondary Intervention: "Reduce Frequency" of Social Communication Intervention Intervention: Social Communication Who: Parent & Child & Therapist Reduce Frequency: 1-hour once/week

Starting Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week Secondary Intervention: "Add Tools" to Social Communication Intervention Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week Add: Video feedback

Starting Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week Secondary Intervention: Switch to Disruptive Behavior Intervention Who: Parent & Therapist only Frequency: 1-hour once/week

Starting Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week Secondary Intervention: "Reduce Frequency" of Disruptive Behavior Intervention Intervention: Disruptive Behavior Who: Parent & Therapist only Reduce Frequency: 1-hour every other week

Starting Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week Secondary Intervention: "Add Tools" to Disruptive Behavior Intervention Intervention: Disruptive Behavior Who: Parent & Therapist & Child Frequency: 1-hour once/week Add: Video feedback

Starting Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week Secondary Intervention: "Switch" to Social Communication Intervention Who: Parent & Child & Therapist Frequency: 1-hour twice/week

Outcomes

Primary Outcome Measures

Observed Child Social Communication
The child's observed social communication is measured from a caregiver-child interaction in which the dyad interacts across a variety of daily activities using materials in their home. This interaction will be recorded and coded for the child's social communication using the codebook from the Early Communication Indicator assessment.
Observed Child Disruptive Behavior
The child's disruptive behavior is measured from a caregiver-child interaction in which the dyad interacts across a variety of daily activities using materials in their home. This interaction will be recorded and coded for the child's disruptive behavior using the Disruptive Behavior Diagnostic Observation (DB-DOS) codebook.
Caregiver Report of Child Social Communication
The caregiver's assessment of the child's social communication is measured from the Developmental Profile 4 Social-Emotional Scale. The Social-Emotional scale values range from 0 (minimum) to 36 (maximum) with higher scores indicating better outcomes.
Caregiver Report of Child Disruptive Behavior
The caregiver's assessment of the child's disruptive behavior is measured from the Eyberg Child Behavior Inventory.
Family Life Impairment Scale
Family life participation outcomes are measured using the Family Life Impairment Scale. The measure's values range from 0 (minimum) to 38 (maximum) with higher scores indicating worse outcomes.

Secondary Outcome Measures

Caregiver Satisfaction
The caregiver's satisfaction with the intervention(s) are measured from a researcher developed satisfaction questionnaire. Sample items include asking about the caregiver's confidence in supporting their child's development, the difficulty in finding time to support their child's development, the added stress of participating in the study, the reasonableness of the study time requirement, the satisfaction with their study therapist's presentation of the material, and whether they would recommend the intervention to another family.
Caregiver Perceived Stress
The caregiver's stress levels are measured using the Perceived Stress Scale. The measure's values range from 0 (minimum) to 40 (maximum) with higher scores indicating worse outcomes.

Full Information

First Posted
June 7, 2023
Last Updated
July 18, 2023
Sponsor
Northwestern University
Collaborators
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT05926687
Brief Title
Optimizing Outcomes for Young Autistic Children
Official Title
Optimizing Outcomes Through Sequencing Parent-Mediated Interventions for Young Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
February 28, 2027 (Anticipated)
Study Completion Date
February 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
University of Texas at Austin

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
The overarching goal of the proposed study is to: (a) determine how best to sequence two parent-mediated interventions: a social communication intervention (Project ImPACT, Improving Parents as Communication Teachers) and a disruptive behavior intervention (Parent Training for Disruptive Behavior) and (b) examine moderators and mediators of intervention outcomes.
Detailed Description
Despite advances in early identification of and intervention for children with autism spectrum disorders (ASD), the long-term outcomes for children with ASD remain variable. As many as 40% of children with ASD are minimally verbal at 9 years of age, and 75% of adults with ASD have persistent social communication (SC) difficulties. Furthermore, as many as 70% of children with ASD have a co-occurring diagnosis of disruptive behavior (DB) disorder. Parents play an important role in SC development and in the prevention of and intervention for DB. As such, the overarching goal of the proposed study is to: (a) determine how best to sequence two parent-mediated interventions: an SC intervention (Project ImPACT, Improving Parents as Communication Teachers) and a DB intervention (Parent Training for Disruptive Behavior) and (b) examine moderators and mediators of intervention outcomes. While evidence of efficacy and feasibility exist for both of these interventions individually, an adaptive intervention approach that considers and optimizes both interventions has not been evaluated. This type of adaptive intervention approach may be particularly needed in parent-mediated interventions due to the cost, burden, and complexity of teaching parents to use multiple intervention strategies. To determine the optimal intervention sequence that considers parent moderators and parent use of intervention strategies, the investigators propose a sequential, multiple assignment, randomized trial (SMART) design in which the investigators will initially randomly assign 184 children with ASD, between 18 and 48 months of age, to receive either the SC or DB intervention. Following each respective manualized, 12-week intervention (first-stage intervention; SC or DB), the interventionist will measure the parents' use of intervention strategies. At this point, all parents will be re-randomized before starting the second-stage intervention. Second-stage intervention decisions are designed to be responsive to parents' implementation of the first-stage intervention strategies. That is, parents who are implementing the first-stage intervention strategies with high fidelity (high implementers) will be re-randomized to receive the same intervention at a lower frequency (Reduce) or to receive the other intervention (Switch). Parents who are implementing the first-stage intervention strategies with low fidelity (low implementers) will be re-randomized to receive the same intervention with an additional parent instructional method, such as video feedback (Augment) or to receive the other intervention (Switch). After 24 weeks of intervention (12 weeks for first stage, 12 weeks for second stage), the investigators will assess child SC skills, child DB, and family life participation in everyday activities. The investigators will also measure parent-child joint engagement continually during intervention to examine the extent to which joint engagement mediates intervention outcomes. The proposed research is significant because if an intervention for one domain (SC or DB) has an impact on the other, an intervention sequence that systematically includes both interventions may have an even greater impact on both domains.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorder
Keywords
intervention, early intervention, toddlers, autistic, autism, virtual, tele-health

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
The investigators propose a sequential, multiple assignment, randomized trial (SMART) design in which the investigators will initially randomly assign 184 children with ASD, between 18 and 48 months of age, to receive either the SC or DB intervention. Following each respective manualized, 12-week intervention (first-stage intervention; SC or DB), the interventionist will measure the parents' use of intervention strategies. At this point, all parents will be re-randomized before starting the second-stage intervention. Participants will be re-randomized to receive the same intervention at a lower frequency (Reduce) or to receive the other intervention (Switch). Parents who need additional parent instructional method, such as video feedback will be randomized to receive additional tools (Augment).
Masking
Outcomes Assessor
Masking Description
Outcome coders will be blind to experimental condition
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social Communication + Reduce Frequency
Arm Type
Active Comparator
Arm Description
Starting Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week Secondary Intervention: "Reduce Frequency" of Social Communication Intervention Intervention: Social Communication Who: Parent & Child & Therapist Reduce Frequency: 1-hour once/week
Arm Title
Social Communication + Add Tools
Arm Type
Active Comparator
Arm Description
Starting Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week Secondary Intervention: "Add Tools" to Social Communication Intervention Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week Add: Video feedback
Arm Title
Social Communication + Switch Intervention to Disruptive Behavior
Arm Type
Active Comparator
Arm Description
Starting Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week Secondary Intervention: Switch to Disruptive Behavior Intervention Who: Parent & Therapist only Frequency: 1-hour once/week
Arm Title
Disruptive Behavior + Reduce Frequency
Arm Type
Active Comparator
Arm Description
Starting Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week Secondary Intervention: "Reduce Frequency" of Disruptive Behavior Intervention Intervention: Disruptive Behavior Who: Parent & Therapist only Reduce Frequency: 1-hour every other week
Arm Title
Disruptive Behavior + Add Tools
Arm Type
Active Comparator
Arm Description
Starting Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week Secondary Intervention: "Add Tools" to Disruptive Behavior Intervention Intervention: Disruptive Behavior Who: Parent & Therapist & Child Frequency: 1-hour once/week Add: Video feedback
Arm Title
Disruptive Behavior + Switch Intervention to Social Communication
Arm Type
Active Comparator
Arm Description
Starting Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week Secondary Intervention: "Switch" to Social Communication Intervention Who: Parent & Child & Therapist Frequency: 1-hour twice/week
Intervention Type
Behavioral
Intervention Name(s)
Social Communication
Other Intervention Name(s)
SC, Project Impact
Intervention Description
Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week
Intervention Type
Behavioral
Intervention Name(s)
Disruptive Behavior
Other Intervention Name(s)
RUBI, DB
Intervention Description
Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week
Intervention Type
Behavioral
Intervention Name(s)
Social Communication + Reduce Frequency
Intervention Description
Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour once/week
Intervention Type
Behavioral
Intervention Name(s)
Social Communication + Add Tools
Intervention Description
Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week
Intervention Type
Behavioral
Intervention Name(s)
Disruptive Behavior + Reduce Frequency
Intervention Description
Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour every other week
Intervention Type
Behavioral
Intervention Name(s)
Disruptive Behavior + Add Tools
Intervention Description
Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week
Primary Outcome Measure Information:
Title
Observed Child Social Communication
Description
The child's observed social communication is measured from a caregiver-child interaction in which the dyad interacts across a variety of daily activities using materials in their home. This interaction will be recorded and coded for the child's social communication using the codebook from the Early Communication Indicator assessment.
Time Frame
Between 25-30 weeks
Title
Observed Child Disruptive Behavior
Description
The child's disruptive behavior is measured from a caregiver-child interaction in which the dyad interacts across a variety of daily activities using materials in their home. This interaction will be recorded and coded for the child's disruptive behavior using the Disruptive Behavior Diagnostic Observation (DB-DOS) codebook.
Time Frame
Between 25-30 weeks
Title
Caregiver Report of Child Social Communication
Description
The caregiver's assessment of the child's social communication is measured from the Developmental Profile 4 Social-Emotional Scale. The Social-Emotional scale values range from 0 (minimum) to 36 (maximum) with higher scores indicating better outcomes.
Time Frame
Between 25-30 weeks
Title
Caregiver Report of Child Disruptive Behavior
Description
The caregiver's assessment of the child's disruptive behavior is measured from the Eyberg Child Behavior Inventory.
Time Frame
Between 25-30 weeks
Title
Family Life Impairment Scale
Description
Family life participation outcomes are measured using the Family Life Impairment Scale. The measure's values range from 0 (minimum) to 38 (maximum) with higher scores indicating worse outcomes.
Time Frame
Between 25-30 weeks
Secondary Outcome Measure Information:
Title
Caregiver Satisfaction
Description
The caregiver's satisfaction with the intervention(s) are measured from a researcher developed satisfaction questionnaire. Sample items include asking about the caregiver's confidence in supporting their child's development, the difficulty in finding time to support their child's development, the added stress of participating in the study, the reasonableness of the study time requirement, the satisfaction with their study therapist's presentation of the material, and whether they would recommend the intervention to another family.
Time Frame
Between 25-30 weeks
Title
Caregiver Perceived Stress
Description
The caregiver's stress levels are measured using the Perceived Stress Scale. The measure's values range from 0 (minimum) to 40 (maximum) with higher scores indicating worse outcomes.
Time Frame
Between 25-30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Child is between 18 and 48 months old Child scores above the research cutoff for ASD on the TELE-ASD-PEDS Child has no other known diagnosis or disability at study entry Child has normal vision Child is exposed to English at least 50% of the time Child has a caregiver willing to learn the intervention strategies Caregiver wants help supporting their child's social communication and behavior regulation Caregiver understands conversational English well enough to participate in caregiver instruction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura J Sudec, MSW
Phone
8474913183
Email
Laura.Sudec@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Y Roberts, PhD
Phone
8474913183
Email
megan.y.roberts@northwestern.edu
Facility Information:
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Y Roberts, PhD
Phone
847-491-3183
Email
megan.y.roberts@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Laura J Sudec, MSW
Phone
847-491-3183
Email
laura.sudec@northwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share the final dataset in two ways: the National Database for Autism Research (NDAR) and the Inter-University Consortium for Political and Social Research (ICPSR).
IPD Sharing Time Frame
Data will be shared once the first published article is available. Data will be available for 10 years.

Learn more about this trial

Optimizing Outcomes for Young Autistic Children

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