Opt-In Early Pilot Study

Official title

Parent Training for Autistic Toddlers: Development and Preliminary Testing

Overview

Latinx and Rural-living children with diagnosed or suspected autism have especially long wait times for diagnoses and intervention, up to a year or even more. This delayed access to intervention is likely to prevent children from reaching their full potential in skills and adaptive functioning. A comprehensive, online mobile device-based, free intervention that can be used by parents while on these wait lists may optimize their child's development. The investigators have developed such a program, the Online Parent Training in Early Intervention (OPT-In-Early) program. It teaches parents the fundamental principles of both applied behavior analysis and naturalistic interventions, uses non-technical language, video demonstrations, guidance in selecting appropriate skills to teach, embedding teaching into daily routines, and reducing interfering behaviors. It is a self-paced, individualized platform giving parents strategies to strengthen the parent-child relationship, to teach basic skills, such as simple communication, to reduce interfering behaviors, and to establish helpful routines. In pilot the RCT, parents (half of whom were self-identified as Latinx) rated the program very highly and showed positive changes in behavior and knowledge. The goal of the current project is to develop, and pilot test a bilingual Spanish/English culturally tailored version of OPT-In-Early for Latinx families in the US, as well as tailoring and testing the program for rural communities of Oregon. First, the investigators will obtain detailed, iterative feedback from bilingual Latinx parents with an autistic child regarding OPT-In-Early. Similar feedback will also be obtained from participants from rural communities of Oregon who also have an autistic child. The investigators will use this feedback to culturally adapt the program content and format. Next, the adapted program will be modified via user testing with Spanish speaking parents and English speaking parents. Finally, the bilingual version will be tested in a six-month pilot RCT, in preparation for a fully powered R01 trial. The investigators will use a wait-list control design: the Intervention Now arm will be given the online program and the Intervention Later arm (controls) will be given educational material about autism. All children will receive a baseline and 6-month follow-up assessment, which will measure parent fidelity in using the intervention principles (the primary outcome), child social communication, level of autism symptoms, impact of autism symptoms, and degree of developmental delays. The Intervention Now group will have two subgroups. One will test the online program with an emphasis placed on the Spanish version, while the other will focus on the English version and complete the program through a rural lens. At the conclusion of this research, the investigators will have developed an evidence-based, comprehensive, freely available, parent-delivered intervention that can be used by US Latinx and rural families on their mobile devices as they await diagnosis and intervention. This will increase parent efficacy and reduce their stress, accelerate children's skills, reduce interfering behavior, and enhance PCPs' willingness to implement universal autism screening.

Interventions

• Other Opt-In Early Latinx intervention
  Participants will access to the Opt-In Early training program website, but will be able to access the Spanish language version as well. Families will fill out a usage diary to record their experience.
• Other Opt-In Early Rural Intervention
  Participants will access to the Opt-In Early training program website. Parents will be able to interact with the rural community-oriented aspects of the program. Families will fill out a usage diary to record their experience.

Primary outcome measures

• Social Interaction Rating Scale (SIRS) [Time frame: It is administered pre- and post-six months of intervention to both groups.]

Secondary outcome measures (4)

• Autism Impact Measure (AIM) [Time frame: Once at baseline evaluation and a second at the end of the six months of intervention.]
• Brief Observation of Social Communication Change (BOSCC) [Time frame: It is administered at the baseline evaluation and after the six months of intervention or psycho-education.]
• Early Intervention Parenting Self-Efficacy Scale (EIPSES) [Time frame: Responses are averaged across items to produce a single parenting self-efficacy score at the baseline evaluation and at the six month post-treatment evaluation.]
• Parenting Stress Index (PSI-4) [Time frame: It is administered at the baseline evaluation and at the six month post-treatment evaluation.]

Eligibility criteria

Inclusion criteria

• Parent-child dyads where the child has a definitive or provisional diagnosis of autism
• Children must be aged 15 - 42 months
• Latinx arm parents must be primarily Spanish-speaking or balanced bilinguals
• Rural arm participants would ideally reside in primarily rural communities (identified with RUCA codes; RUCA score >5)

Exclusion criteria

• Diagnosed with another major developmental condition (e.g., Down Syndrome, Hearing Impairment)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Connecticut Children's Medical Center — Hartford
• Oregon Health & Science University — Portland

Publications

• Ruble, L., McDuffie, A., King, A. S., & Lorenz, D. (2008). Caregiver responsiveness and social interaction behaviors of young children with autism. Topics in Early Childhood Special Education, 28(3), 158-170
• Nielsen J. Usability Engineering. San Diego, CA: Academic Press; 1993.
• Mazurek MO, Carlson C, Baker-Ericzen M, Butter E, Norris M, Kanne S. Construct Validity of the Autism Impact Measure (AIM). J Autism Dev Disord. 2020 Jul;50(7):2307-2319. doi: 10.1007/s10803-018-3462-8. PMID 29344761
• Mazurek MO, Carlson C, Baker-Ericzen M, Butter E, Norris M, Barr C, Kanne S. The Autism Impact Measure (AIM): Examination of Sensitivity to Change. Autism Res. 2020 Nov;13(11):1867-1879. doi: 10.1002/aur.2397. Epub 2020 Oct 1. PMID 33001561
• Kelley, M. L., Hefer, R. W., Gresham, F. M., & Elliott, S. N. (1989). Development of a modified treatment evaluation inventory. Journal of Psychopathology and Behavioral Assessment, 11(3), 235-247.
• Kanne SM, Mazurek MO, Sikora D, Bellando J, Branum-Martin L, Handen B, Katz T, Freedman B, Powell MP, Warren Z. The Autism Impact Measure (AIM): initial development of a new tool for treatment outcome measurement. J Autism Dev Disord. 2014 Jan;44(1):168-79. doi: 10.1007/s10803-013-1862-3. PMID 23748386
• Herlihy L, Knoch K, Vibert B, Fein D. Parents' first concerns about toddlers with autism spectrum disorder: effect of sibling status. Autism. 2015 Jan;19(1):20-8. doi: 10.1177/1362361313509731. Epub 2013 Nov 11. PMID 24216070
• Guimond, A. B., Wilcox, M. J., & Lamorey, S. G. (2008). The Early Intervention Parenting SelfEfficacy Scale (EIPSES) scale construction and initial psychometric evidence. Journal of Early Intervention, 30(4), 295-320

Identifiers

NCT: NCT06908187 · STUDY00025956 · R34MH132712 · no number

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗