Optimizing Outcomes for Young Autistic Children

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926687
• Other study ID #: STU00216950
• Status: Recruiting
• Phase: Phase 2
• Start date: July 11, 2023
• Est. completion date: February 28, 2027

Study information

• Verified date: June 2023
• Source: Northwestern University
• Contact: Laura J Sudec, MSW
• Phone: 8474913183
• Email: Laura.Sudec[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: February 28, 2027
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 48 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• Social Communication
Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week
• Disruptive Behavior
Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week
• Social Communication + Reduce Frequency
Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour once/week
• Social Communication + Add Tools
Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week
• Disruptive Behavior + Reduce Frequency
Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour every other week
• Disruptive Behavior + Add Tools
Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week

Locations

Country	Name	City	State
United States	Northwestern University	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.	Between 25-30 weeks
Primary	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
Primary	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
Secondary	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
Secondary	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