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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02928068
Other study ID # STUDY00002264
Secondary ID
Status Completed
Phase N/A
First received October 6, 2016
Last updated November 15, 2017
Start date April 2015
Est. completion date June 2017

Study information

Verified date November 2017
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy of a 12 week telehealth intervention for families of children with autism spectrum disorders under the age of 6 years on child participation and parent efficacy.


Description:

Autism spectrum disorders (ASD) are increasingly being diagnosed in children, creating a pressing need for effective and cost-efficient models of early intervention (EI) services. Many EI systems are struggling to meet the needs of the increasing number of families of children with ASD. In rural areas, there is a shortage of EI therapists, and the distances to reach families results in an inefficient use of professional time and research shows that rural families of children with ASD receive fewer EI services, which has detrimental effects on children's developmental trajectories. If occupational therapy interventions for young children with ASD utilize innovative methods of service delivery in rural areas, investigators can increase the number of families that receive services thereby positively influencing child and family outcomes. Therefore, investigators propose to test the acceptability, cost-effectiveness, and efficacy of a 12 week telehealth intervention for families of young children with ASD.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 84 Months
Eligibility Inclusion Criteria:

- Family with a child up to 72 months old with a diagnosis of ASD and primarily spoke English in the home.

Exclusion Criteria:

- Child has significant visual or hearing impairments or has a known genetic condition associated with autism (e.g., Fragile X Syndrome).

Study Design


Intervention

Behavioral:
Occupational Performance Coaching (OPC)
OPC focuses on increasing positive child-caregiver interactions and child learning opportunities in everyday routines and contexts, which positions families for improved trajectories over time. OPC capitalizes on families' strengths, while supporting caregivers in using their own resources and ideas to advance child function. Caregivers identify goals, while therapists ask reflective questions and make reflective comments, affording caregivers an opportunity to gain a deeper understanding of their own current knowledge and the impact of their strategies on their children's adaptive behavior. Thus, families generate their own solutions and are ultimately responsible for carrying out the intervention and evaluating its effectiveness.

Locations

Country Name City State
United States Occupational Therapy Education Kansas City Kansas

Sponsors (1)

Lead Sponsor Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parent Sense of Competence Scale 12 weeks
Secondary Canadian Occupational Performance Measure 12 weeks
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