Heterogeneity in ASD: Biological Mechanisms, Trajectories, and Treatment Response

Summary

Parent-mediated interventions often target social communication in young children with ASD, although to date studies yield inconsistent effects. One reason for the limited evidence may be the considerable heterogeneity in both parent and child characteristics that affect the fit of intervention to family and ultimately influence treatment outcome. For parents, these factors might include stress associated with the uncertainty of their child's diagnosis, caregiver expectations for the intervention itself, and a parent's own style of interaction that may be influenced by milder but qualitatively similar ASD characteristics, known as the broad autism phenotype (BAP). For children, these factors might include nonverbal DQ, language, or sensory impairment. The fit between type of intervention and optimal outcome for parent and child is an understudied, yet essential component of early intervention that may be susceptible to the influence of heterogeneity in the parent and child. One approach to addressing this variability is to implement an adaptive intervention approach that seeks to capitalize on heterogeneity among children and parents. Utilizing an adaptive treatment design, the current study tests the optimal sequence of intervention delivery and specific parent and child characteristics that may moderate treatment success in three 10-week stages of intervention. The first phase will randomize parents and children to a parent education condition, consisting of a parent support and education group focused on social communication development, or to a parent mediated and therapist delivered condition involving coaching of the parent with their child in social communication strategies. Phase 2 involves re-randomizing parents and children to maintain the same treatment arm, or change to the opposite arm to test the optimal sequence of intervention delivery and specific parent and child characteristics that may moderate treatment success. In the final phase, dyads are randomized to different maintenance arms, each comprised of 5 sessions with one involving skype and text contact, the other in -home visits, to explore how best to maintain treatment gains once the active intervention phase is complete. This study has the potential to dramatically improve child social communication outcomes by individualizing and personalizing parent intervention approaches with very young children, a high priority need of the Interagency Autism Coordinating Council and NIH.

Conditions

• Children With Autism

Interventions

BEHAVIORAL

PARENT focused intervention

The group will comprise 3 to 4 parents and will focus on psychoeducation and support/well-being for the parent. Sessions will include a 20-minute welcome and supportive discussion where parents can provide updates on their week and seek advice and support from the group, followed by a 45-minute interactive education session focused on the principles of JASPER, and close with a 20-minute Mindfulness session. The Mindfulness session will be led by a certified expert.

BEHAVIORAL

CHILD focused intervention

The session will be divided into 30-minute segments and include two 30-minute individualized 1-on-1 sessions with a trained interventionist. One of these two sessions will involve the parent in hands-on training while the other will be interventionist-led while the parent observes. The remaining 30-minutes will include a snack for the child and time for the parent to discuss and ask questions of the interventionist regarding the session content.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of California, Los Angeles

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

36 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-15

Primary Completion

2023-09-30

Completion

2024-09-30

Countries

• United States

Study Locations