Goal attainment scaling as an outcome measure in randomized controlled trials of psychosocial interventions in autism.
Lisa Ruble, John H McGrew, Michael D Toland
https://pubmed.ncbi.nlm.nih.gov/22271197Actively Recruiting
Phase Not Applicable
Age: 16Months - 48Months
All Genders
ID07081724
Opt In - Implementation and Evaluation of an Early Intervention Program for Children Waiting to Receive an Autism Diagnosis
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 children's 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 child's 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
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
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
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (phone screen)
Baseline Assessments and Enrollment
Duration - Up to 1 month prior to intervention
Participants complete baseline assessments including online forms and phone interviews to capture child's adaptive functioning, autism symptom severity, and individualized goals. Caregivers provide videos illustrating current child behavior related to goals.
1 baseline visit (online and phone)
Treatment
Duration - 6 months
Participants randomized to the OPT-In-Early group receive access to a self-directed online early behavioral intervention program for 6 months. Caregivers learn and apply intervention strategies with optional clinician support calls for guidance. Participants in the waitlist group do not receive intervention during this time.
Participants use the online program at their own pace with optional support calls up to three times per week
Post-intervention Assessments
Duration - Within 1 month after intervention
After 6 months, participants undergo post-intervention assessments identical to baseline, including caregiver interviews and videos to evaluate changes in child skills and parental wellbeing.
1 post-intervention visit (online and phone)
Trial Site Locations
Total: 1 location
1
A.J. Drexel Autism Institute
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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