Autism Spectrum DisorderASPENNCT04505488
Efficacy of the ASPEN Intervention Program in Low-Resource Communities
A study testing ASD Screening Parent ENgagement Intervention Program (ASPEN) in people with Autism Spectrum Disorder, run by University of Texas at Austin at 1 site in United States.
Trial summary
The ASD Screening and Parent ENgagement (ASPEN) program is a culturally adapted, parent-mediated intervention program. The ASPEN program is tailored to address social communication and behavioral difficulties that young children with developmental delays may experience in early childhood. Read more about this study
- Who is it for?
- Ages 18 months to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- ASD Screening Parent ENgagement Intervention Program (ASPEN)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2020to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is between 18 months through 6 years of age
- Child has a medical diagnosis or educational classification of Autism or Autism Spectrum Disorder (ASD) or child is at-risk for Autism/ASD as determined by the Modified-Checklist for Autism in Toddlers - Revised/Follow-up Interview (M-CHAT-R/F) and/or Social Communication Questionnaire (SCQ)
- Child resides in a low-resource household as determined by at least one of the following criteria:
- -Child or family has Medicaid as an insurance provider
- -Child's primary caregiver has achieved a high school or lower education
- -Child resides in a household with an annual income of 200% of the Federal Poverty Level
Who cannot join
- Primary caregiver does not speak/understand English or Spanish
- Child is younger 18 months or older than 6 years of age
- Child does not have a medical diagnosis or educational classification of Autism/ASD or does not meet at-risk criteria on the M-CHAT-R/F and/or SCQ
- Child does not reside in low-resource household
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the ASD Screening and Parent ENgagement (ASPEN) Intervention Program in Low-Resource Communities
The ASD Screening and Parent ENgagement (ASPEN) program is a culturally adapted, parent-mediated intervention program. The ASPEN program is tailored to address social communication and behavioral difficulties that young children with developmental delays may experience in early childhood. The ASPEN Program includes 12 sessions where parents are provided with psychoeducation about self-care, child development, and evidence-based strategies. Coaching is also provided to train parents on using evidence-based strategies within the home setting. The ASPEN program is delivered by a student clinician and a peer leader. We hypothesize that coaching strategies delivered by the clinician will lead to primary family caregivers learning evidence-based strategies and this will result in improved child outcomes. We hypothesize that education and family support delivered by peer leaders will help primary family caregivers learn social support strategies and this will lead to improved parent outcomes.
- Conditions
- Autism Spectrum Disorder
- Being tested
- ASD Screening Parent ENgagement Intervention Program (ASPEN)
- Keywords
- Autism, Parent-mediated intervention, Naturalistic developmental behavioral intervention, Low resource households
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASD Screening Parent ENgagement Intervention Program (ASPEN)Behavioural
Also called ASPEN
The ASPEN intervention is based on naturalistic developmental behavioral intervention strategies to support the development of social communication and play skills and reduce challenging behavior.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive a parent manual, a resource packet, and 12 weekly sessions delivered by the clinician and peer leader. Receives: Behavioral: ASD Screening Parent ENgagement Intervention Program (ASPEN) |
| Control Group | No intervention | The control group will receive a parent manual and a resource packet. Four phone check-ins will be conducted across 12-14 weeks to address questions by the research team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptive Behavior
Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome
Measured: Baseline to Post-Intervention (12-14 weeks post baseline) Change
Adaptive Behavior
Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome
Measured: Baseline to Follow-Up (24-28 weeks post baseline) Change
Parenting Stress
Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome
Measured: Baseline to Post-Intervention (12-14 weeks post baseline) Change
Parenting Stress
Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome
Measured: Baseline to Follow-Up (24-28 weeks post baseline) Change
Parent Empowerment
Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome
Measured: Baseline to Post-Intervention (12-14 weeks post baseline) Change
Parent Empowerment
Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome
Measured: Baseline to Follow-Up (24-28 weeks post baseline) Change
Secondary outcomes (4)
Child Challenging Behavior
Scales of Independent Behavior-Revised: Problem Behavior Subscale Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome
Measured: Baseline to Post-Intervention (12-14 weeks post baseline) Change
Child Challenging Behavior
Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome
Measured: Baseline to Follow-Up (24-28 weeks post baseline) Change
Family Quality of Life
PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome
Measured: Baseline to Post-Intervention (12-14 weeks post baseline) Change
Family Quality of Life
PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome
Measured: Baseline to Follow-Up (24-28 weeks post baseline) Change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start11 Feb 2020
- Primary completion5 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Sandra B. Vanegas, University of Texas at Austin
- Investigators
- Sandra B Vanegas, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505488
- Sponsor's protocol ID
- 90IFST0004
- Acronym
- ASPEN
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2020
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Vanegas SB, Magana S. Outcomes from the ASPEN intervention program: a randomized clinical trial of a culturally adapted parent-mediated intervention program in low-resource settings. Front Psychiatry. 2026 Jun 19;17:1795918. doi: 10.3389/fpsyt.2026.1795918. eCollection 2026.
PubMed 42404716
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the ASD Screening and Parent ENgagement (ASPEN) Intervention Program in Low-Resource Communities
- ClinicalTrials.gov ID
- NCT04505488
- Acronym / sponsor ID
- ASPEN / 90IFST0004
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism, Parent-mediated intervention, Naturalistic developmental behavioral intervention, Low resource households
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ASD Screening and Parent ENgagement (ASPEN) program is a culturally adapted, parent-mediated intervention program. The ASPEN program is tailored to address social communication and behavioral difficulties that young children with developmental delays may experience in early childhood. The ASPEN Program includes 12 sessions where parents are provided with psychoeducation about self-care, child development, and evidence-based strategies. Coaching is also provided to train parents on using evidence-based strategies within the home setting. The ASPEN program is delivered by a student clinician and a peer leader. We hypothesize that coaching strategies delivered by the clinician will lead to primary family caregivers learning evidence-based strategies and this will result in improved child outcomes. We hypothesize that education and family support delivered by peer leaders will help primary family caregivers learn social support strategies and this will lead to improved parent outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: ASD Screening Parent ENgagement Intervention Program (ASPEN)The intervention group will receive a parent manual, a resource packet, and 12 weekly sessions delivered by the clinician and peer leader. |
| Control Group | No intervention | –The control group will receive a parent manual and a resource packet. Four phone check-ins will be conducted across 12-14 weeks to address questions by the research team. |
Who may qualify
- Ages
- 18 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child is between 18 months through 6 years of age
- Child has a medical diagnosis or educational classification of Autism or Autism Spectrum Disorder (ASD) or child is at-risk for Autism/ASD as determined by the Modified-Checklist for Autism in Toddlers - Revised/Follow-up Interview (M-CHAT-R/F) and/or Social Communication Questionnaire (SCQ)
- Child resides in a low-resource household as determined by at least one of the following criteria:
- -Child or family has Medicaid as an insurance provider
- -Child's primary caregiver has achieved a high school or lower education
Key exclusion criteria (4 listed)
- Primary caregiver does not speak/understand English or Spanish
- Child is younger 18 months or older than 6 years of age
- Child does not have a medical diagnosis or educational classification of Autism/ASD or does not meet at-risk criteria on the M-CHAT-R/F and/or SCQ
- Child does not reside in low-resource household
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASD Screening Parent ENgagement Intervention Program (ASPEN)Also: ASPENThe ASPEN intervention is based on naturalistic developmental behavioral intervention strategies to support the development of social communication and play skills and reduce challenging behavior. | Behavioural | Intervention Group |
Primary outcome
Adaptive Behavior
Time frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome
Adaptive Behavior
Time frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome
Parenting Stress
Time frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome
Parenting Stress
Time frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome
Parent Empowerment
Time frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome
Parent Empowerment
Time frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome
4 secondary outcomes
Child Challenging Behavior
Time frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
Child Challenging Behavior
Time frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
Family Quality of Life
Time frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
Family Quality of Life
Time frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Derived from this study: PubMed 42404716Vanegas SB, Magana S. Outcomes from the ASPEN intervention program: a randomized clinical trial of a culturally adapted parent-mediated intervention program in low-resource settings. Front Psychiatry. 2026 Jun 19;17:1795918. doi: 10.3389/fpsyt.2026.1795918. eCollection 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra B Vanegas, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASD Screening Parent ENgagement Intervention Program (ASPEN) in people with Autism Spectrum Disorder, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adaptive Behavior (time frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04505488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.