Optimizing Outcomes for Young Autistic Children

Optimizing Outcomes Through Sequencing Parent-Mediated Interventions for Young Children With Autism

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Behavioral: Social Communication; Behavioral: Social Communication + Reduce Frequency; Behavioral: Social Communication + Add Tools; Behavioral: Disruptive Behavior; Behavioral: Disruptive Behavior + Reduce Frequency; Behavioral: Disruptive Behavior + Add Tools

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.

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Megan Y Roberts, PhD; Phone Number: 8474913183; Email: megan.y.roberts@northwestern.edu
• Study Contact Backup: Name: Laura J Sudec, MSW; Phone Number: 8474913183; Email: Laura.Sudec@northwestern.edu

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Recruiting
      • Northwestern University
      • Contact: Megan Y Roberts, PhD; Phone Number: 847-491-3183; Email: megan.y.roberts@northwestern.edu
      • Contact: Laura J Sudec, MSW; Phone Number: 847-491-3183; Email: laura.sudec@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Social Communication + Reduce Frequency; 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	Behavioral: Social Communication; Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week; Other Names: SC; Project Impact; Behavioral: Social Communication + Reduce Frequency; Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour once/week
Active Comparator: Social Communication + Add Tools; 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	Behavioral: Social Communication; Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week; Other Names: SC; Project Impact; Behavioral: Social Communication + Add Tools; Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week
Active Comparator: Social Communication + Switch Intervention to Disruptive Behavior; 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	Behavioral: Social Communication; Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week; Other Names: SC; Project Impact; Behavioral: Disruptive Behavior; Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week; Other Names: DB; RUBI
Active Comparator: Disruptive Behavior + Reduce Frequency; 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	Behavioral: Disruptive Behavior; Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week; Other Names: DB; RUBI; Behavioral: Disruptive Behavior + Reduce Frequency; Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour every other week
Active Comparator: Disruptive Behavior + Add Tools; 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	Behavioral: Disruptive Behavior; Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week; Other Names: DB; RUBI; Behavioral: Disruptive Behavior + Add Tools; Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week
Active Comparator: Disruptive Behavior + Switch Intervention to Social Communication; 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	Behavioral: Social Communication; Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week; Other Names: SC; Project Impact; Behavioral: Disruptive Behavior; Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week; Other Names: DB; RUBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Between 25-30 weeks
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.	Between 25-30 weeks
Caregiver Report of Child Disruptive Behavior	The caregiver's assessment of the child's disruptive behavior is measured from the Eyberg Child Behavior Inventory.	Between 25-30 weeks
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.	Between 25-30 weeks
Caregiver Report of Child Social Communication	The caregiver's assessment of the child's social communication is measured from the Developmental Profile 4 (DP-4) Social-Emotional and Communication Scales. This assessment will yield a total raw score ranging from 0 (minimum) to 70 (maximum), with higher scores indicating better outcomes.	Between 25-30 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Between 25-30 weeks
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.	Between 25-30 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: autism; intervention; early intervention; virtual; autistic; tele-health; toddlers
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: STU00216950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No