Autism Spectrum DisordersNCT02928068
Telehealth Coaching for Families of Children With Autism
A study testing Occupational Performance Coaching (OPC) in people with Autism Spectrum Disorders, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 84 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Occupational Performance Coaching (OPC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 84 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Family with a child up to 72 months old with a diagnosis of ASD and primarily spoke English in the home.
Who cannot join
- Child has significant visual or hearing impairments or has a known genetic condition associated with autism (e.g., Fragile X Syndrome).
Trial locations and contacts
1 site in 1 country.
United States1 site
Occupational Therapy Education
Kansas City, Kansas, 66160
About this study
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.
Read the detailed 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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Occupational Performance Coaching (OPC)
- Keywords
- telehealth
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Performance Coaching (OPC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Occupational Performance Coaching (OPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Sense of Competence Scale
Measured: 12 weeks
Secondary outcomes (1)
Canadian Occupational Performance Measure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Little, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928068
- Sponsor's protocol ID
- STUDY00002264
- Status last verified
- Nov 2017
- First submitted
- 6 Oct 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29426380
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Coaching for Families of Children With Autism
- ClinicalTrials.gov ID
- NCT02928068
- Acronym / sponsor ID
- STUDY00002264
- Conditions
- Autism Spectrum Disorders
- Keywords
- telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 7 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occupational Performance Coaching (OPC) | Experimental | Behavioral: Occupational Performance Coaching (OPC)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. |
Who may qualify
- Ages
- 12 to 84 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Family with a child up to 72 months old with a diagnosis of ASD and primarily spoke English in the home.
Key exclusion criteria (1 listed)
- Child has significant visual or hearing impairments or has a known genetic condition associated with autism (e.g., Fragile X Syndrome).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Occupational Performance Coaching (OPC) |
Primary outcome
Parent Sense of Competence Scale
Time frame: 12 weeks
1 secondary outcome
Canadian Occupational Performance Measure
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 29426380Little 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Little, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Performance Coaching (OPC) in people with Autism Spectrum Disorders, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Sense of Competence Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02928068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.