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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 16Months - 48Months
All Genders
ID07081724

Online Parent Training for Caregivers of Toddlers Waiting for an Autism Diagnosis A Self-Directed Early Intervention Program for Children Aged 16 to 48 Months

Led by Drexel University · Updated on 2026-01-28

120

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

D

Drexel University

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating an early behavioral intervention program for toddlers aged 16 to 48 months who are waiting to receive a formal autism diagnosis. The study aims to address delays in autism diagnosis and intervention by offering caregivers access to a self-directed online training resource during the waitlist period. This approach seeks to empower parents to support their childrens development early, potentially reducing the harms associated with waiting for diagnosis and intervention services. Participants will be randomly assigned to either receive access to the Online Parent Training in Early Behavioral Intervention OPT-In-Early program or be placed on a waitlist without intervention for six months. The OPT-In-Early program includes 14 modules 6 mandatory and 8 optional with text and video materials teaching caregivers strategies to improve language, social, and adaptive skills and reduce disruptive behaviors. Parents can also schedule brief support calls with a clinician for guidance during the intervention period. After six months, waitlist participants will gain access to the program, but outcomes will not be measured for them. Throughout the study, caregivers complete assessments including individualized goal setting with video recordings to capture their childs current skills and progress. Standardized measures of adaptive behavior, parental stress, and autism-related challenges are collected at baseline and after six months. Researchers will monitor program engagement using website usage data and support call frequency. The primary outcome is change in goal attainment as measured by Goal Attainment Scaling, with additional measures assessing adaptive functioning and parental well-being. The total participation time is six months, during which families receive ongoing support and data collection.

CONDITIONS

Brief Title

"Opt-In" Early Intervention Program for Children Waiting to Receive an Autism Diagnosis

Who Can Participate

Age: 16Months - 48Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 16 and 48 months
  • Parental consent provided
  • Currently on a waitlist for a formal diagnostic evaluation due to autism concerns
  • Parent or caregiver speaks English
  • Initial score of 8 or greater or Follow-Up score of 2 or greater on the Modified Checklist for Autism in Toddlers, Revised, with Follow-Up (M-CHAT-R/F) indicating autism likelihood
Not Eligible

You will not qualify if you...

  • Already received a formal diagnosis of autism
  • Enrolled in early intervention programs delivering more than 5 hours per week of evidence-based autism-specific interventions at consent
  • Child born before 36 weeks gestational age with birth weight less than 2500 grams
  • Child is not yet walking
  • Child has severe hearing or vision impairment not corrected with aids
  • Child has a known neurological disorder or genetic syndrome such as Down syndrome

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