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NCT Number: NCT05926687

Optimizing Outcomes for Young Autistic Children

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.

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Key information

Age range

18 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social Communication

Behavioral

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

Other names: SC, Project Impact

Disruptive Behavior

Behavioral

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

Other names: RUBI, DB

Social Communication + Reduce Frequency

Behavioral

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

Social Communication + Add Tools

Behavioral

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

Disruptive Behavior + Reduce Frequency

Behavioral

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

Disruptive Behavior + Add Tools

Behavioral

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

Primary outcomes

  1. Observed Child Social Communication

    Time frame: 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.

  2. Observed Child Disruptive Behavior

    Time frame: 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.

  3. Caregiver Report of Child Social Communication

    Time frame: Between 25-30 weeks

    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.

  4. Caregiver Report of Child Disruptive Behavior

    Time frame: Between 25-30 weeks

    The caregiver's assessment of the child's disruptive behavior is measured from the Eyberg Child Behavior Inventory.

  5. Family Life Impairment Scale

    Time frame: 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 outcomes

  1. Caregiver Satisfaction

    Time frame: 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.

  2. Caregiver Perceived Stress

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura J Sudec, MSW

CONTACT

[email protected]

8474913183

Megan Y Roberts, PhD

CONTACT

[email protected]

8474913183

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • University of Texas at Austin

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 3, 2023
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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