Autism Spectrum DisorderNCT03592654
Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder
A study testing infant telehelp in people with Autism Spectrum Disorder and Developmental Delay, run by University of California, Davis at 1 site in United States.
Trial summary
Caregiver coaching will be provided using telehealth technology, in order to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD. Read more about this study
- Who is it for?
- Ages 5 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Developmental Delay
- What is being tested?
- infant telehelp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 1 Oct 2019
- 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 5 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants must exhibit early symptoms of ASD as indicated by a combination of Autism Observation Scale for Infants (AOSI) scores of 7 or higher
- and Infant Toddler Checklist (ITC) scores in the autism concern range
- Expression of clinical concern about ASD risk by the assessor and caregiver
- Caregivers must be identified as the infants' primary caregivers
- Caregivers be English speaking
- Caregivers must have access to wired or wireless network technology to access the internet in their homes.
Who cannot join
- Infants may not have had significant abnormalities in the pre-, peri-, and postnatal period or gestational age younger than 34 weeks
- Infants may not have serious medical conditions involving repeated or lengthy hospitalizations, head injuries, seizures, cerebral palsy or impaired hand use
- Infants may not have multiple daily administrations of medical treatment (e.g., nebulizers daily)
- Infants may not have known genetic syndrome associated with ASD (e.g., fragile X syndrome) Infants may not have moderate to severe visual, auditory, or motor impairments
- A caregiver may be excluded from participation if the caregiver is engaging in the majority of all possible caregiver treatment target behaviors at therapeutic levels during intake (Fidelity of Implementation scores of 80% or higher on each caregiver target behavior).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder- Infant TeleHelp Study
Caregiver coaching will be provided using telehealth technology, in order to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD.
Read the detailed description
Ideally, all caregivers with an infant identified with concern for ASD would have immediate access to good quality caregiver coaching provided in the most natural environment possible. However, this is currently not the case for the majority of families. There are no empirically validated treatment programs for infants showing ASD risk. The proposed research project will use Applied Behavior Analysis-based single-subject experimental designs to further develop a promising caregiver-mediated intervention designed for infants showing early signs of ASD. Caregiver coaching will be provided using telehealth technology, in order to maximize recruitment opportunities and to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD.
- Conditions
- Autism Spectrum Disorder, Developmental Delay
- Being tested
- infant telehelp
- Medical subject headings
- Autism Spectrum Disorder, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infant telehelpBehavioural
Adapted from Early Start Denver Model (ESDM), a naturalistic developmental behavioral intervention
| Study group | Role | What they receive |
|---|---|---|
| infant telehelp condition | Experimental | caregiver coaching to improve infant behaviors that indicate they are at risk for autism spectrum disorder Receives: Behavioral: infant telehelp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Behaviors Targeted by Intervention
Treatment-targeted child behaviors (e.g., visual fixations on objects, abnormal repetitive behaviors, lack of age-appropriate phonemic development, lack of coordination of gaze, affect, and voice in reciprocal, turn-taking interactions) will be coded from 10-minute caregiver-infant dyad intervention video probes taken throughout all phases of the study.
Measured: 7 months
Secondary outcomes (7)
Autism Observation Scale for Infants
(AOSI; Bryson et al., 2006) The AOSI will be administered by caregivers at intake and exit. During the AOSI, infants are engaged in semi-structured play and systematic presses are designed to assess various target behaviors, including visual tracking and attention disengagement, coordination of eye gaze and action, imitation, affective responses, early social-communicative behaviors, behavioral reactivity, and sensory-motor development.
Measured: 7 months
Ages and Stages Questionnaires, 3rd Edition
(ASQ-3; Squires \& Bricker, 2015) The ASQ-3 are a series of questionnaires completed by a child's caregiver designed to assess the developmental performance of infants and children ages 1-66 months across five developmental areas: communication, gross motor, fine motor, problem solving, and personal-social. The ASQ-3 takes approximately 15 minutes to be completed.
Measured: 7 months
Individual Growth and Development Indices
(IGDIs; Carta et al., 2010) IGDIs were developed to gather very frequent assessment of child developmental progress. We will use the Early Communication Index, ECI, and the Early Problem Solving Index, EPSI, domains appropriate for ages 5 to 50 mos. Two 6-minute semi-structured and video recorded play procedures will be carried out at intake and exit.
Measured: 7 months
Vineland Adaptive Behavior Scales, 2nd edition
(VABS-II; Sparrow et al., 2005) The VABS-II consists of four domains of adaptive behavior: communication, self-care, social, and motor skills. The VABS-II is a semi-standardized caregiver questionnaire or interview designed to assess children's behavior in real life, everyday settings.
Measured: 7 months
Parent Satisfaction Rating
(Charlop-Christy \& Carpenter, 2000) This is a measure of social validity, or acceptability, of the experimental treatment, to caregivers. This scale will be administered to the caregivers at intake and exit. This tool allows caregivers to rate the ease of implementation in the home and their opinions concerning treatment utility.
Measured: 7 months
Working Alliance Scale for Interventions with Children
(Davis et al., 2006). These measures will be administered to the caregivers at intake and exit and will be used to describe the response of the families to the experimental intervention, and thus constitutes another measure of social validity.
Measured: 7 months
Caregiver Fidelity of Treatment Implementation
Caregiver fidelity of implementation (FI) of the Infant Start intervention will be coded from 10-minute caregiver-child dyad intervention video probes to determine caregivers' FI of intervention techniques over the course of the study. The fidelity tool involves having experts in Infant Start rate caregiver use of each of the intervention strategies on a 1-5 Likert rating scale, with a code of "1" meaning the caregiver did not implement the technique throughout the session and a code of "5" meaning the caregiver implemented the technique correctly throughout the session.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Jul 2018
- Primary completion18 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- single subject multiple baseline design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Dufek, PhD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592654
- Sponsor's protocol ID
- 1249018
- Status last verified
- Sep 2020
- First submitted
- 25 Jun 2018
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder- Infant TeleHelp Study
- ClinicalTrials.gov ID
- NCT03592654
- Acronym / sponsor ID
- 1249018
- Conditions
- Autism Spectrum Disorder, Developmental Delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 19 Jul 2018 (actual)
- 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.
Caregiver coaching will be provided using telehealth technology, in order to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD.
Detailed description
Ideally, all caregivers with an infant identified with concern for ASD would have immediate access to good quality caregiver coaching provided in the most natural environment possible. However, this is currently not the case for the majority of families. There are no empirically validated treatment programs for infants showing ASD risk. The proposed research project will use Applied Behavior Analysis-based single-subject experimental designs to further develop a promising caregiver-mediated intervention designed for infants showing early signs of ASD. Caregiver coaching will be provided using telehealth technology, in order to maximize recruitment opportunities and to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single subject multiple baseline design
| Arm | Type | Receives |
|---|---|---|
| infant telehelp condition | Experimental | Behavioral: infant telehelpcaregiver coaching to improve infant behaviors that indicate they are at risk for autism spectrum disorder |
Who may qualify
- Ages
- 5 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infants must exhibit early symptoms of ASD as indicated by a combination of Autism Observation Scale for Infants (AOSI) scores of 7 or higher
- and Infant Toddler Checklist (ITC) scores in the autism concern range
- Expression of clinical concern about ASD risk by the assessor and caregiver
- Caregivers must be identified as the infants' primary caregivers
- Caregivers be English speaking
Key exclusion criteria (5 listed)
- Infants may not have had significant abnormalities in the pre-, peri-, and postnatal period or gestational age younger than 34 weeks
- Infants may not have serious medical conditions involving repeated or lengthy hospitalizations, head injuries, seizures, cerebral palsy or impaired hand use
- Infants may not have multiple daily administrations of medical treatment (e.g., nebulizers daily)
- Infants may not have known genetic syndrome associated with ASD (e.g., fragile X syndrome) Infants may not have moderate to severe visual, auditory, or motor impairments
- A caregiver may be excluded from participation if the caregiver is engaging in the majority of all possible caregiver treatment target behaviors at therapeutic levels during intake (Fidelity of Implementation scores of 80% or higher on each caregiver target behavior).
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 |
|---|---|---|
| infant telehelpAdapted from Early Start Denver Model (ESDM), a naturalistic developmental behavioral intervention | Behavioural | infant telehelp condition |
Primary outcome
Child Behaviors Targeted by Intervention
Time frame: 7 months
Treatment-targeted child behaviors (e.g., visual fixations on objects, abnormal repetitive behaviors, lack of age-appropriate phonemic development, lack of coordination of gaze, affect, and voice in reciprocal, turn-taking interactions) will be coded from 10-minute caregiver-infant dyad intervention video probes taken throughout all phases of the study.
7 secondary outcomes
Autism Observation Scale for Infants
Time frame: 7 months
Ages and Stages Questionnaires, 3rd Edition
Time frame: 7 months
Individual Growth and Development Indices
Time frame: 7 months
Vineland Adaptive Behavior Scales, 2nd edition
Time frame: 7 months
Parent Satisfaction Rating
Time frame: 7 months
Working Alliance Scale for Interventions with Children
Time frame: 7 months
Caregiver Fidelity of Treatment Implementation
Time frame: 7 months
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 4 Sep 2020.
- 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.
Sarah Dufek, PhD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infant telehelp in people with Autism Spectrum Disorder and Developmental Delay, run by University of California, Davis 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 6 inclusion and 5 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 4 Sep 2020. 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?
Child Behaviors Targeted by Intervention (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2020.