Efficacy of the ASPEN Intervention Program in Low-Resource Communities (NCT04505488) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of the ASPEN Intervention Program in Low-Resource Communities
United States180 participantsStarted 2020-02-11
Plain-language 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. 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.
Who can participate
Age range
18 Months – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adaptive Behavior
Timeframe: Baseline to Post-Intervention (12-14 weeks post baseline) Change
2
Adaptive Behavior
Timeframe: Baseline to Follow-Up (24-28 weeks post baseline) Change
3
Parenting Stress
Timeframe: Baseline to Post-Intervention (12-14 weeks post baseline) Change
4
Parenting Stress
Timeframe: Baseline to Follow-Up (24-28 weeks post baseline) Change
5
Parent Empowerment
Timeframe: Baseline to Post-Intervention (12-14 weeks post baseline) Change
6
Parent Empowerment
Timeframe: Baseline to Follow-Up (24-28 weeks post baseline) Change