An interventional study of PARENT focused intervention and CHILD focused intervention in Children With Autism, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 12 Months to 36 Months. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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.
While social communication is a core developmental deficit that characterizes children with ASD, there is great heterogeneity in both presentation and gains with treatment. Long term outcomes of children with ASD vary with nearly 40% remaining minimally verbal by school age. Beginning early and providing high doses of intervention appears critical to child outcomes, and one cost-effective, efficient way to accomplish these goals is to involve parents. Particularly, for very young children (under the age of 3 years) who may not have a confirmed ASD diagnosis, parent mediated interventions have several advantages. One is that there is potential for earlier access to evidence based interventions. Parents can intervene with their child immediately without waiting for access through a lengthy diagnostic process or for therapist -delivered interventions that can have long wait times. Another is that parents can increase the dose of an intervention since they are with their child for many more hours than non-family members.
Despite the increasing numbers of parent mediated interventions, inconsistent results are noted. A few studies have found significant differences in both child and parent outcomes but others find limited to no effects on parent and/or child. This heterogeneity in outcomes is often attributed to child characteristics or to the intervention itself. However, the fit between type of intervention-focused on the parent-(education about social communication in their child, or stress reduction interventions), or focused on the child-(parent coached to work directly with their child)-has rarely been examined in parents engaged in these interventions. Fit may be influenced by parent characteristics that can affect their ability to implement the interventions.
These include stress associated with the uncertainty of their child's diagnosis, caregiver expectations for the intervention itself, and parent's own style of interaction that may be influenced by milder but qualitatively similar ASD characteristics, known as the broad autism phenotype.
It is widely recognized that a single intervention is not effective for all parents and children. One approach to addressing this variability is to implement an adaptive intervention approach that seeks to capitalize on heterogeneity and evolving status among children and parents. An adaptive intervention is a replicable, sequence of treatment decision rules designed to help guide clinicians concerning whether, how or when-and based on which measures-to provide certain intervention components. This type of intervention design provides information on the most effective intervention for children and parents who need it (leading to individualized and personalized sequences of treatment). Using a novel experimental design, the proposed study will develop a more effective adaptive intervention by addressing the following specific aims:
Primary Aim (Best Initial Strategy): To determine the effect of PARENT focused intervention vs CHILD focused intervention on change in child initiated joint engagement (primary outcome), play, and joint attention (secondary outcomes) from baseline to end of phase 1. Hypothesis: Children will improve more, on average, when offered CHILD focused intervention.
Secondary Aim 1 (Best Sequence): To compare and contrast the four pre-specified adaptive interventions from baseline to end of phase 2 on primary and secondary outcomes. Hypothesis: The sequential intervention beginning with CHILD focused interventions followed by PARENT education sessions will lead to the most improved outcomes.
Secondary Aim 2 (Toward More Personalized Intervention Sequences): To develop a more individually- tailored adaptive intervention by examining whether parental factors including BAP, parental stress, or parent's expectancies for the intervention, and child factors including non-verbal DQ, language or sensory impairment at baseline moderates the effect of Phase 1 interventions from baseline to end of Phase 1 on primary and secondary outcomes. Hypotheses: (i) Children with parents who report greater BAP and parenting stress will benefit more from PARENT focused intervention and children with parents who report greater expectancy will benefit more from CHILD focused intervention. (ii) Children with low non-verbal DQ and high levels of sensory impairment at baseline will benefit more from the CHILD focused intervention from baseline to end of phase 1. Secondary Aim 3 (Maintenance Protocol): To determine the maintenance effect of in person home visits versus technology supported maintenance protocol on change in primary and secondary outcomes from (i) baseline to end of phase 3 and (ii) from end of phase 2 to end of phase 3. Hypothesis: Children in the home visit maintenance protocol will have more improved outcomes from baseline to end of phase 3 compared to the children in the technology supported maintenance protocol.
Secondary Aim 4 (Exploratory: Biomarkers and Genetics): To characterize children at risk of ASD in terms of electrophysiological biomarkers (neural synchrony measured by EEG power, peak alpha frequency and coherence) and genetic risk (as measured by the presence of CNVs and polygenetic risk score) and to explore each's role as a biological moderator of treatment effects.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's enrollment of 81 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Do not have seizures or are stable on anti-seizure medication
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
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
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.
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.
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.
Time frame: 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
Early Social- Communication Scales
In this semi-structured interaction, the child and tester sit facing each other at a table with a set of toys in view but out of reach of the child which are introduced one by one (Mundy, Sigman, Ungerer, \& Sherman, 1986; Seibert, Hogan, \& Mundy, 1982).
Time frame: 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
SPA-R is designed to obtain the child's highest levels of spontaneous play acts. The child is presented with 5 different play sets by the experimenter; the entire play interaction last about 15-20 minutes. The child's play behaviors are videotaped and later coded. The variables of interest include the frequency of child initiated functional and symbolic play acts and also the count of different novel types of acts. This measure has shown excellent reliability and validity across a range of studies (Kasari et al., 2006; Sigman \& Ruskin, 1999; Sigman \& Ungerer, 1984).
Time frame: 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)
total parental stress
Time frame: 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)
score comprised of three subscales: aloof, rigid and pragmatic language.
Time frame: Baseline (entry)
Caregiver Expectancies /Belief in the Intervention
This measure (Nock \& Kazdin, 2001) assesses parent's beliefs about whether the intervention is appropriate and working for his/her child. It reflects the parent's motivation to participate, their belief in the intervention's value, and its effectiveness. Scoring of the measure consists of a series of ratings on a Likert scale summed to obtain a total score.
Time frame: Baseline (entry)
BOSCC
Social Communication Total Score
Time frame: Baseline(entry), Phase 1 mid(5 weeks post entry) and end(10 weeks post entry); Phase 2 mid (15 weeks post entry) and end(20 weeks post entry); Phase 3 mid (25 weeks post entry) and end (30 weeks post entry) and I year follow up post entry
Caregiver-child interaction (CCX)
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). Change will be recorded and measured throughout the study for joint attention and play.
Time frame: 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
Nonverbal Developmental Quotients (DQ) from Mullen
Nonverbal Development Quotients (DQ) (DQ; mental age ÷ chronological age)
Time frame: Baseline
An electroencephalogram (EEG) test
EEG
Time frame: Baseline
Presence of copy-number variations (CNVs)
DNA
Time frame: Baseline
Polygenetic risk score (PRS)
DNA
Time frame: Baseline
Sensory Impairment from ITSP
Sensory impairment score
Time frame: Baseline
Ran from Jun 2018 to primary completion in Sep 2023, 63 months.
Of 354 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's 63 months is above that.
Counting every sponsor, half of 366 studies reached it within 26 months; a quarter within 13 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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