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/22271197/Actively Recruiting
Led by Drexel University · Updated on 2026-01-28
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
"Opt-In" Early Intervention Program for Children Waiting to Receive an Autism Diagnosis
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Drexel University
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | OPT-In-Early (Online Parent Training for Early Behavioral Intervention) | Waitlist (No Intervention During Waiting Period) |
|---|---|---|
| What is it? | A self-directed online program for parents with modules teaching evidence-based behavioral methods to improve language, social, adaptive, and self-help skills in children likely to have autism. Parents access text and video demonstrations and apply techniques in daily routines. | No early intervention is delivered during the study period. Families continue standard waiting for diagnostic evaluation without additional support or new intervention. |
| Role in the trial | Assigned as the experimental arm to test whether parent-guided behavioral strategies delivered before diagnosis can improve goal attainment and adaptive functioning. | Acts as the control arm, representing usual practice of waiting for diagnosis without early autism-specific intervention. |
| Primary use or purpose | To enable caregivers to apply behavioral strategies in daily activities to improve their child's language, social, and adaptive skills while waiting for formal autism assessment. | To serve as a comparison group representing children with no new intervention during the wait for diagnostic evaluation. |
| How is it given or performed? | Parents access 14 online modules (6 mandatory, 8 optional) including text and videos, learn skills such as prompting, shaping and fading, and implement these behavioral techniques during everyday home routines. No in-person therapy required. | Families are not provided new educational resources or direct behavioral training while waiting for diagnostic evaluation. |
| Evidence status | Published literature supports goal attainment scaling as an outcome measure for evaluating psychosocial interventions in autism, but results for OPT-In-Early are not yet established. The current trial will assess effectiveness using this method. | No autism-specific intervention is given during waiting; children may not receive additional support unless enrolled in other programs. This group reflects typical waitlist outcomes, which may include slower progress until intervention is provided. |
| Important limitations | The OPT-In-Early intervention requires caregiver motivation and internet access; results may depend on parent engagement and prior experience. Effects on children with severe developmental or sensory impairments are not established. | Lack of early intervention may delay skill development and increase caregiver stress. Outcomes may be influenced by external factors such as access to informal support or length of waiting period. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (phone screen)
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)
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
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)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Lisa Ruble, John H McGrew, Michael D Toland
https://pubmed.ncbi.nlm.nih.gov/22271197/Drexel University
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor