Adaptation and Implementation of an ASD Executive Functioning Intervention in Children's Mental Health Services
Phase: NA
Conditions: Autism Spectrum Disorder, Mental Health Disorder, Executive Dysfunction
Sponsor: San Diego State University

ClinialTrials.gov Document Information 
 
Official Study Title:  
Adaptation and Implementation of an ASD Executive Functioning Intervention in Children's 
Mental Health Services 
 
ID: HS-2018-0147 
 
NCT Number: NCT04295512. 
 
Date: Apr 27, 2020 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Objectives 
Tailoring evidence-based interventions for delivery in community-based mental health services 
for youth with autism spectrum disorder (ASD)  has the potential to increase quality of care and 
improve child outcomes. Results from the current study will serve as the foundation for large-
scale hybrid implementation and effectiveness trials and a generalizable approach for different 
service systems of care and clinical populations. Youth with ASD represent a growing 
population with significant service needs. Prominent among these needs are high rates of co-
occurring psychiatric conditions that contribute to increased functional impairments and often 
necessitate mental health services. Executive functioning deficits are associated with ASD as 
well as common co-occurring conditions (e.g., attention-deficit/hyperactivity disorder) and an 
evidence-based intervention has been developed and tested to address executive functioning 
within the school context. There is an urgent need to implement indicated evidence-based 
interventions for youth with ASD receiving care in community mental health settings. 
Interventions that optimally “fit” the mental health services context as well as the complex and 
co-occurring mental health needs of these youth have the potential to improve key clinical 
outcomes for this high priority population. 
Objectives 
Specific objectives are to (1) conduct a need and context assessment to inform the systematic 
adaptation an executive functioning evidence-based intervention; (2) systematically adapt the 
clinical intervention and develop a corresponding implementation plan, together entitled 
“Executive Functioning for Enhancing Community-based Treatment for ASD,” (EFFECT for 
ASD); and (3) conduct a feasibility pilot test of EFFECT for ASD in community mental health 
settings. 
Methods 
This mixed-methods developmental study will apply the Exploration, Preparation, 
Implementation, Sustainment implementation framework and a community-academic 

partnership approach to systematically adapt and test an evidence-based executive functioning 
intervention for youth with ASD for delivery in community mental health settings. See Dickson et 
al., 2020 in the ‘References module’ for a detailed description of all methods throughout the 
multi-aim study.  
Statistical Plan 
Descriptive analyses and examination of qualitative themes related to perceptions of the 
feasibility, acceptability, and appropriateness of Unstuck and On Target will be used to evaluate 
intervention effectiveness and implementation outcomes. For quantitative implementation 
outcome measures, criteria for determining sufficient feasibility, acceptability, and 
appropriateness will be applied, including examination of mean-level ratings on relevant 
measures and whether mean scores are greater than or equal to ratings indicating perceived 
feasibility, acceptability and/or appropriateness (e.g., ≥4 on Feasibility and Acceptability of 
Interventions measures, ≥4 on subscales on the Perceived Characteristics of Intervention 
Scale). Scores will also be compared to prior relevant literature. For example, fidelity scores will 
also be analyzed and compared to prior trials of UOT to determine if providers achieve similar 
fidelity levels, indicating appropriate uptake and fidelity. Finally and informed by current 
recommendations and prior work93, objective measures of outcomes (e.g., recruitment and 
enrollment, proportion of sessions completed, attrition) will also be examined. Intervention 
effects analyses will also be conducted, including Group (intervention vs. control) x Time (pre to 
post), will be conducted to examine changes in outcome measures over time; analyses will be 
conducted using recommended procedures (e.g., maximum likelihood) to adjust for missing 
data and non-normality of outcome variables. Informed by similar pilot feasibility trials, the 
targeted sample size (n=26) allows for dropout rates similar to that of prior pilot studies in the 
same setting while also meeting the threshold for sufficiently precise parameter estimates. Per 
current recommendations, direction of effects and effect size estimation will be examined given 
the small sample size. Consistent with a Type III Scale-Out, this pilot study adapts an evidence-

based intervention for a new population and delivery systems and will borrow statistical strength 
by comparing findings to prior studies regarding evidence of UOT. As such, we anticipate an 
effect size that approximates the medium effect observed in the UOT randomized-clinical trial30 
(average Cohen’s d= .55).