Optimizing Outcomes for Young Autistic Children

Northwestern University

Status and phase: Enrolling; Phase 2

Conditions: Autism Spectrum Disorder; Autism

Treatments: Behavioral: Social Communication + Add Tools; Behavioral: Social Communication; Behavioral: Disruptive Behavior + Add Tools; Behavioral: Social Communication + Reduce Frequency; Behavioral: Disruptive Behavior + Reduce Frequency; Behavioral: Disruptive Behavior

Study type: Interventional

Funder types: Other

Identifiers

NCT05926687

STU00216950

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 estimated patients

Sex: All

Ages: 18 to 48 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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184 participants in 6 patient groups

Social Communication + Reduce Frequency

Active Comparator group

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

Treatment:

Behavioral: Social Communication + Reduce Frequency

Behavioral: Social Communication

Social Communication + Add Tools

Active Comparator group

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

Treatment:

Behavioral: Social Communication + Add Tools

Behavioral: Social Communication

Social Communication + Switch Intervention to Disruptive Behavior

Active Comparator group

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

Treatment:

Behavioral: Disruptive Behavior

Behavioral: Social Communication

Disruptive Behavior + Reduce Frequency

Active Comparator group

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

Treatment:

Behavioral: Disruptive Behavior + Reduce Frequency

Behavioral: Disruptive Behavior

Disruptive Behavior + Add Tools

Active Comparator group

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

Treatment:

Behavioral: Disruptive Behavior

Behavioral: Disruptive Behavior + Add Tools

Disruptive Behavior + Switch Intervention to Social Communication

Active Comparator group

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

Treatment:

Behavioral: Disruptive Behavior

Behavioral: Social Communication