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Optimizing Outcomes for Young Autistic Children

NCT ID: NCT05926687

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-11

Study Completion Date

2027-02-28

Brief Summary

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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

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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.

Conditions

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Autism Autism Spectrum Disorder

Keywords

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intervention early intervention toddlers autistic autism virtual tele-health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome coders will be blind to experimental condition

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Social Communication

Intervention Type BEHAVIORAL

Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week

Social Communication + Reduce Frequency

Intervention Type BEHAVIORAL

Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour once/week

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

Group Type ACTIVE_COMPARATOR

Social Communication

Intervention Type BEHAVIORAL

Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week

Social Communication + Add Tools

Intervention Type BEHAVIORAL

Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week

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

Group Type ACTIVE_COMPARATOR

Social Communication

Intervention Type BEHAVIORAL

Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week

Disruptive Behavior

Intervention Type BEHAVIORAL

Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week

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

Group Type ACTIVE_COMPARATOR

Disruptive Behavior

Intervention Type BEHAVIORAL

Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week

Disruptive Behavior + Reduce Frequency

Intervention Type BEHAVIORAL

Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour every other week

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

Group Type ACTIVE_COMPARATOR

Disruptive Behavior

Intervention Type BEHAVIORAL

Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week

Disruptive Behavior + Add Tools

Intervention Type BEHAVIORAL

Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week

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

Group Type ACTIVE_COMPARATOR

Social Communication

Intervention Type BEHAVIORAL

Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week

Disruptive Behavior

Intervention Type BEHAVIORAL

Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week

Interventions

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Social Communication

Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week

Intervention Type BEHAVIORAL

Disruptive Behavior

Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week

Intervention Type BEHAVIORAL

Social Communication + Reduce Frequency

Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour once/week

Intervention Type BEHAVIORAL

Social Communication + Add Tools

Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week

Intervention Type BEHAVIORAL

Disruptive Behavior + Reduce Frequency

Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour every other week

Intervention Type BEHAVIORAL

Disruptive Behavior + Add Tools

Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week

Intervention Type BEHAVIORAL

Other Intervention Names

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SC Project Impact RUBI DB

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Megan Roberts

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University

Evanston, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Laura J Sudec, MSW

Role: CONTACT

Phone: 8474913183

Email: [email protected]

Megan Y Roberts, PhD

Role: CONTACT

Phone: 8474913183

Email: [email protected]

Facility Contacts

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Megan Y Roberts, PhD

Role: primary

Laura J Sudec, MSW

Role: backup

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

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STU00216950

Identifier Type: -

Identifier Source: org_study_id