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

NCT03253081 | Completed

• 1 other identifier: 2P50HD055784-11
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Joint Engagement on the Caregiver-child interaction (CCX) over the course of the study

  A 10-minute interaction between parent and child. These sessions will be carried out with a standard set of toys and videotaped. Parents will be asked to engage their child in play as usual. Coders blind to child treatment assignment and time point will code the videotapes according to Adamson et al, 2004 coding procedures, the same as used in our previous studies (Harris, Kasari, \& Sigman, 1996; Kasari et al, 2006; Kasari, et al, 2008). Joint engagement change will be recorded and measured throughout the study.

  Baseline(entry), Phase1 midpoint (5 weeks post entry) and end(10 weeks post entry), Phase2 midpoint (15 weeks post entry) and end(20 weeks post entry), and Phase3 midpoint(25 weeks post entry) and end(30 weeks post entry), and 1 year follow-up post entry

Secondary Outcomes (7)

• Early Social- Communication Scales

  Baseline(entry), Phase 1 end(10 weeks post entry), Phase 2 end(20 weeks post entry), Phase 3 end(30 weeks post entry), and 1 year follow-up post entry

• The Structured Play Assessment-R

  Baseline(entry), Phase 1 end(10 weeks post entry), Phase 2 end (20 weeks post entry), Phase 3 end (30 weeks post entry), and 1 year follow-up post entry

• Parenting Stress Index (PSI)

  Baseline(entry), Phase 1 end(10 weeks post entry), Phase 2 end(20 weeks post entry), Phase 3 end(30 weeks post entry), and 1 year follow-up post entry

• The Broader Autism Phenotype Questionnaire (BAPQ)

  Baseline (entry)

• Caregiver Expectancies /Belief in the Intervention

  Baseline (entry)

Other Outcomes (5)

• Nonverbal Developmental Quotients (DQ) from Mullen

  Baseline

• An electroencephalogram (EEG) test

  Baseline

• Presence of copy-number variations (CNVs)

  Baseline

Study Arms (2)

PARENT focused intervention

ACTIVE COMPARATOR

The PF condition will consist of a 90-minute parent group session twice per week. The group will comprise 3 to 4 parents and will focus on psychoeducation and support/well-being for the parent.

Behavioral: PARENT focused intervention

CHILD focused intervention

ACTIVE COMPARATOR

In the CF condition both parent and child will attend the 90-minute session twice weekly. The session will be divided into 30-minute segments and include two 30-minute individualized 1-on-1 sessions with a trained interventionist.

Behavioral: CHILD focused intervention

Interventions

PARENT focused intervention BEHAVIORAL

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.

PARENT focused intervention

CHILD focused intervention BEHAVIORAL

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.

CHILD focused intervention

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Have elevated scores on the ADOS-2 and clinical concern from a professional (Pediatrician, Psychologist, etc.). For children under the age of 30 months, some of whom may not have a diagnosis of ASD, they must show elevated risk in the mild-to-moderate or moderate-to-severe risk categories on the ADOS-T. For children over the age of 30 months, they must meet clinical cutoff on the ADOS-2, Module 1 or 2.
• Are between 12 months and 36 months
• Have a parent available for parent-mediated sessions 2 times per week in the classroom

You may not qualify if:

• Do not have seizures or are stable on anti-seizure medication
• Do not have associated physical disorders
• Are not co-morbid with other syndromes or diseases unless they come from Project I in our center- 22q11 deletion or TSC children at 12 months with concern for ASD on the ADOS-T.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90024, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 17, 2017
• Study Start: June 15, 2018
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)