NCT02928068

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

2.2 years

First QC Date

October 6, 2016

Last Update Submit

November 15, 2017

Conditions

Keywords

telehealth

Outcome Measures

Primary Outcomes (1)

  • Parent Sense of Competence Scale

    12 weeks

Secondary Outcomes (1)

  • Canadian Occupational Performance Measure

    12 weeks

Study Arms (1)

Occupational Performance Coaching (OPC)

EXPERIMENTAL

This group received approximately 12 sessions of the telehealth intervention. The intervention consisted of parent-therapist conversations via telehealth to increase child function and participation.

Behavioral: Occupational Performance Coaching (OPC)

Interventions

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.

Occupational Performance Coaching (OPC)

Eligibility Criteria

Age12 Months - 84 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Occupational Therapy Education

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • Little LM, Pope E, Wallisch A, Dunn W. Occupation-Based Coaching by Means of Telehealth for Families of Young Children With Autism Spectrum Disorder. Am J Occup Ther. 2018 Mar/Apr;72(2):7202205020p1-7202205020p7. doi: 10.5014/ajot.2018.024786.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Lauren Little, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 7, 2016

Study Start

April 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations