跳至主要内容
临床试验/NCT05926687
NCT05926687招募中2 期

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

Northwestern University1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2023年7月11日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
184
试验地点
1
主要终点
Observed Child Disruptive Behavior

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome coders will be blind to experimental condition

入排标准

年龄范围
18 Months 至 48 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

Social Communication + Reduce Frequency

Active Comparator

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

干预措施: Social Communication (Behavioral)

Social Communication + Reduce Frequency

Active Comparator

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

干预措施: Social Communication + Reduce Frequency (Behavioral)

Social Communication + Add Tools

Active Comparator

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

干预措施: Social Communication (Behavioral)

Social Communication + Add Tools

Active Comparator

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

干预措施: Social Communication + Add Tools (Behavioral)

Social Communication + Switch Intervention to Disruptive Behavior

Active Comparator

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

干预措施: Social Communication (Behavioral)

Social Communication + Switch Intervention to Disruptive Behavior

Active Comparator

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

干预措施: Disruptive Behavior (Behavioral)

Disruptive Behavior + Reduce Frequency

Active Comparator

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

干预措施: Disruptive Behavior (Behavioral)

Disruptive Behavior + Reduce Frequency

Active Comparator

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

干预措施: Disruptive Behavior + Reduce Frequency (Behavioral)

Disruptive Behavior + Add Tools

Active Comparator

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

干预措施: Disruptive Behavior (Behavioral)

Disruptive Behavior + Add Tools

Active Comparator

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

干预措施: Disruptive Behavior + Add Tools (Behavioral)

Disruptive Behavior + Switch Intervention to Social Communication

Active Comparator

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

干预措施: Social Communication (Behavioral)

Disruptive Behavior + Switch Intervention to Social Communication

Active Comparator

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

干预措施: Disruptive Behavior (Behavioral)

结局指标

主要结局

Observed Child Disruptive Behavior

时间窗: 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 Disruptive Behavior

时间窗: 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

时间窗: 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.

Observed Child Social Communication

时间窗: 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.

Caregiver Report of Child Social Communication

时间窗: 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.

次要结局

  • Caregiver Perceived Stress(Between 25-30 weeks)
  • Caregiver Satisfaction(Between 25-30 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Megan Roberts

Principal Investigator

Northwestern University

研究点 (1)

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