Optimizing Outcomes for Young Autistic Children

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05926687

Collaborator

University of Texas at Austin (Other)

184

Enrollment

Location

Arms

44.9

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Autism Spectrum Disorder	Behavioral: Social Communication Behavioral: Disruptive Behavior Behavioral: Social Communication + Reduce Frequency Behavioral: Social Communication + Add Tools Behavioral: Disruptive Behavior + Reduce Frequency Behavioral: Disruptive Behavior + Add Tools	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

184 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention 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).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:

Single (Outcomes Assessor)

Masking Description:

Outcome coders will be blind to experimental condition

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Feb 28, 2027

Anticipated Study Completion Date :

Feb 28, 2027

Arms and Interventions

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: RUBI DB
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: RUBI DB 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: RUBI DB 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: RUBI DB

Outcome Measures

Primary Outcome Measures

Observed Child Social Communication [Between 25-30 weeks]
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 [Between 25-30 weeks]
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 [Between 25-30 weeks]
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 [Between 25-30 weeks]
The caregiver's assessment of the child's disruptive behavior is measured from the Eyberg Child Behavior Inventory.
Family Life Impairment Scale [Between 25-30 weeks]
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 [Between 25-30 weeks]
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 [Between 25-30 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 48 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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