NCT04295512

Adaptation and Implementation of an ASD Executive Functioning Intervention in Children's Mental Health Services

Completed NA Results posted Last updated 27 February 2025

What this trial tests

NA trial testing Unstuck and on Target in Autism Spectrum Disorder in 75 participants. Completed in 31 May 2023.

Timeline

15 July 2021

Primary endpoint
20 May 2023

31 May 2023

Quick facts

Lead sponsor	San Diego State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	75
Start date	15 July 2021
Primary completion	20 May 2023
Estimated completion	31 May 2023
Sites	1 location across United States

Drugs / interventions tested

• Unstuck and on Target

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
• Mental Health Disorder — all drugs for Mental Health Disorder →
• Executive Dysfunction — all drugs for Executive Dysfunction →

Sponsor

San Diego State University

Who can join

Adults 5 to 13, any sex, with Autism Spectrum Disorder or Mental Health Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acceptability of Intervention Measure Primary · 6 months after starting implementation

The Acceptability of Intervention Measure (AIM) measure includes four items assessing the acceptability of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher acceptability. This measure were designed to assess mental health providers' perceptions regarding acceptability of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores

Group	Value	95% CI
Therapists- Unstuck and On Target	4.58	± 0.46

Intervention Appropriateness Measure Primary · 6 months after starting implementation

The Intervention Appropriateness Measure (IAM) measure includes four items assessing the appropriateness of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher appropriateness. This measure was designed to assess mental health providers' perceptions regarding appropriateness of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Sc

Group	Value	95% CI
Therapists - Unstuck and On Target	4.62	± 0.47

Feasibility of Intervention Measure Primary · 6 months after starting implementation

The Feasibility of Intervention Measure (FIM) measure includes 4 items assessing the feasibility of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher feasibility. This measure was designed to assess mental health providers' perceptions regarding feasibility of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an over

Group	Value	95% CI
Therapists- Unstuck and On Target	4.5	± 0.61

Average of Provider Fidelity Throughout Implementation Period Primary · A single, averaged value of all fidelity scores has been calculated. Average fidelity represents scores over the course of 6 months of therapist implementation. Table rows represent different aspects of fidelity that were scored.

Provider adherence or fidelity to the Unstuck and On Target intervention will be measured through observational coding of provider in-session behaviors using the fidelity measure developed as part of the Unstuck and On Target intervention. Observers rate the provider's use of Unstuck and On Target on 9 components, using a 5-point (1 to 5) Likert scale, with higher scores indicating higher fidelity. For this report, a single, averaged value of all fidelity scores has been calculated per component.

Home Practice Review

Group	Value	95% CI
Usual Care	1.36	± 0.56
Unstuck and On Target	3.26	± 1.42

Content Delivery

Group	Value	95% CI
Usual Care	1.44	± 0.84
Unstuck and On Target	4.74	± 0.61

Use of Visuals

Group	Value	95% CI
Usual Care	2.10	± 1.13
Unstuck and On Target	4.64	± 0.66

Use of Handouts

Group	Value	95% CI
Usual Care	1.57	± 0.82
Unstuck and On Target	4.70	± 0.76

Use of Vocabulary

Group	Value	95% CI
Usual Care	1.75	± 1.00
Unstuck and On Target	4.47	± 0.67

Goal, Why, Plan, Do, Check

Group	Value	95% CI
Usual Care	1.25	± 0.77
Unstuck and On Target	4.18	± 1.05

Models Skills (Flexibility, planning)

Group	Value	95% CI
Usual Care	2.47	± 0.78
Unstuck and On Target	3.95	± 0.79

Use of More Positive Praise than Correction

Group	Value	95% CI
Usual Care	4.63	± 0.44
Unstuck and On Target	4.79	± 0.57

Child Behavior Checklist Primary · At baseline and 6 months post-implementation.

Child Behavior Checklist (CBCL) is a parent-report measure of child problem behavior. The CBCL is divided into three broadband scales (Internalizing, Externalizing, and Total Problem Scores) and several associate subscale scores. For this study, only the broadband scales were utilized for analyses. Scores are represented as T-scores with a population mean of 50 with standard deviation of 10 and ranges from 30 (minimum) to 95 (maximum. Higher scores reflect more mental health symptoms. The values reported below represent the mean change in the T-scores from the Total, Internalizing, and Externa

Change in Total Problem Score

Group	Value	95% CI
Usual Care: Children	-4.54	± 6.22
Unstuck and On Target: Children	-2.33	± 4.53

Change in Internalizing Behavior Score

Group	Value	95% CI
Usual Care: Children	-2.64	± 6.38
Unstuck and On Target: Children	-1.67	± 4.17

Change in Externalizing Behavior Score

Group	Value	95% CI
Usual Care: Children	-5.36	± 5.35
Unstuck and On Target: Children	-1.87	± 6.97

Eyberg Child Behavior Inventory Secondary · At baseline and 6 months post-implementation.

The Eyberg Child Behavior Inventory is a 36 item questionnaire of child behavior. Caregivers of participating youth completed the questionnaire to assess their perceptions of their child's disruptive behaviors. The Eyberg Child Behavior Inventory Intensity Scale score measures the frequency of a child's behavioral problems and ranges from 36 (minimum value) to 352 (maximum). A score of 127 or higher is considered to be in the clinical range. The values reported below represent the mean change in the average T-score from baseline to 6 months post intervention for each condition group. Negati

Group	Value	95% CI
Children- Usual Care	-7.09	± 8.47
Children- Unstuck and On Target	1.85	± 9.53

Wechsler Abbreviated Scale of Intelligence Second Edition- Block Design Subscale Secondary · At baseline and 6 months post-implementation.

The Wechsler Abbreviated Scale of Intelligence Second Edition, is a brief measure of intelligence. We administered the Block Design subscale, a timed visual construction task that measures changes in nonverbal reasoning ability by assessing an individual's capacity to analyze and synthesize abstract visual stimuli, demonstrating visual-spatial skills, and coordinating visual perception with motor actions to replicate geometric patterns using colored blocks.The subtest is scored by converting the raw scores into scale scores using standardized norms. Scores range from 1 (minimum) to 19 (maximum

Group	Value	95% CI
Children- Usual Care	5.18	± 7.99
Children- Unstuck and On Target	.79	± 6.29

Executive Functioning Challenge Task Secondary · At baseline and 6 months post-implementation.

The Executive Functioning Challenge Task deliberately tests a child's ability to utilize key executive functions like planning and flexibility by presenting scenarios that reveal potential areas of difficulty in their executive functioning skills. The test yields Flexibility and Planning raw scores with a minimum of 0 and maximum of 8. Higher scores indicate greater impairment in executive functioning. A total executive functioning raw score is also calculated as the sum of planning and flexibility scores. Values below represent the change in average raw scores from baseline to post-intervent

Change in Planning Score

Group	Value	95% CI
Children- Usual Care	-0.09	± 1.81
Children- Unstuck and On Target	-2.21	± 1.97

Change in Flexibility Score

Group	Value	95% CI
Children- Usual Care	-.82	± 2.93
Children- Unstuck and On Target	-0.79	± 1.63

Change in Executive Functioning Total Score

Group	Value	95% CI
Children- Usual Care	-.91	± 4.01
Children- Unstuck and On Target	-3.00	± 2.80

Behavior Rating Inventory of Executive Function Second Edition Secondary · At baseline and 6 months post-implementation.

The Behavior Rating Inventory of Executive Function- Second Edition is a 63-item rating scale completed by caregivers to assess executive function impairment in children. T scores have a population mean of 50 and standard deviation of 10, with a minimum score of 30 and maximum score of 95. Scales assessed included the Behavioral Regulation Index, Emotion Regulation Index and Cognitive Regulation Index, together forming an overall composite score, the Global Executive Composite. Values below represent the change in T-scores scores from baseline to post-intervention for participating children. T

Change in Behavioral Regulation Index T-Score

Group	Value	95% CI
Children- Usual Care	-2.82	± 8.94
Children- Unstuck and On Target	-3.54	± 5.39

Change in Emotion Regulation Index T-Score

Group	Value	95% CI
Children- Usual Care	-2.82	± 10.42
Children- Unstuck and On Target	-0.31	± 6.96

Change in Cognitive Regulation Index T-Score

Group	Value	95% CI
Children- Usual Care	-1.55	± 7.09
Children- Unstuck and On Target	-2.62	± 7.68

Change in Global Executive Composite T-Score

Group	Value	95% CI
Children- Usual Care	-2.82	± 7.43
Children- Unstuck and On Target	-2.46	± 6.12

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events data monitored throughout the 2 year study. Broader oversight for adverse events was provided by a Data Safety and Monitoring Committee (DSMB) selected before data collection began. The DSMB met repeatedly during the study at an average of 2 times a year through study completion (average of 4 meetings over the 2 year duration of the study).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Usual Care: Therapists

Serious: 0/18 (0%)

Deaths: 0/18

Unstuck and On Target: Therapists

Serious: 0/23 (0%)

Deaths: 0/23

Usual Care: Children

Serious: 0/12 (0%)

Deaths: 0/12

Unstuck and On Target: Children

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (1 terms — click to expand)

Reaction	System	Usual Care: Therapists	Unstuck and On Target: The…	Usual Care: Children	Unstuck and On Target: Chi…
No Adverse Events were observed during the course of the study	Psychiatric disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04295512 adverse events section.

Sponsor's own description

The purpose of this project is to conduct a feasibility test of an ASD executive functioning intervention adapted for mental health settings, including examining the effectiveness and process of implementing this adapted intervention in community mental health programs.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Adaption and pilot implementation of an autism executive functioning intervention in children's mental health services: a mixed-methods study protocol.
   Dickson KS, Aarons GA, Anthony LG, Kenworthy L, et al · · 2020 · cited 12× · PMID 32699642 · DOI 10.1186/s40814-020-00593-2