Please assess the completion status of the following clinical trial:

Trial Title: Intensive Intervention for Toddlers With Autism (EARLY STEPS)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: None
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion criteria: (1) 12-24 months of age at the time of telephone screening and living within 60 minutes of the university clinic; (2) ambulatory; (3) unimpaired hand use; (4) parent agreement to have a caregiver present during all home sessions; (5) attendance at all intake sessions; (6) permission to videotape evaluations and ESDM treatment; (7) English as one primary language of the parent; (8) unimpaired hearing and vision; (9) developmental quotient of 35 or higher on the Mullen Scales of Early Learning (MSEL); and (10) meets all of these ASD diagnostic criteria: (a) Autism Diagnostic Observation Scale for Toddlers (ADOS-T) cutoff score of 12 if child produces no words or 10 if child produces some words; (b) agreement by two experienced psychologists that ASD is present; and that child meets DSM-IV criteria for Autistic Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS). 5,7,8 Exclusion criteria: (1) serious parental substance abuse; (2) parental self-report of bipolar disorder or psychosis; (3) known genetic syndromes; (4) serious medical conditions (e.g., encephalitis, concussion, seizure disorder); (5) significant sensory impairment; (6) birth weight \<1600 grams and/or gestational age \< 34 weeks; (7) history of intraventricular hemorrhage; (8) known exposure to neurotoxins (including alcohol, drugs); (9) non-English-speaking parents; and for the ESDM-assigned group only, (10) current enrollment in an intensive, 1:1 delivered behavioral intervention of more than 10 hours per week. There was no other restrictions on additional community-based treatment.

- Gender: ALL
- Minimum Age: 12 Months
- Maximum Age: 24 Months
- Healthy Volunteers: f

Study Arms:
- 1 Early Start Denver Model (Type: EXPERIMENTAL): Phase 1 of ESDM intervention: 12 weekly, 1 to 1.5 hr. sessions focused on teaching \& coaching parents to use the ESDM in all natural caretaking routines \& play periods with their child. Parents are taught \& coached on 1 aspect of the ESDM each week in the clinic session, \& then practice it at home daily in natural family routines \& play.~Phase 2: each child in the ESDM will receive 25 hrs. a week of ESDM intervention in their homes, 50 wks. a year, for 2 years. 20 hrs. weekly will be delivered by trained interventionists (ITs); 5 hrs. weekly will be delivered by parents. (ITs) will provide ten 2 hour teaching episodes involving play activities per week in the home. Parents will continue to deliver the ESDM in natural family routines \& play activities. In addition, each child will receive additional services through public services, or other therapies that the parents may choose, for several more hrs. per week.
- 2 Standard Care available in the Community (Type: OTHER): Any intervention that were available and that families accessed in their communities

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete