Autism Spectrum DisorderNCT05604326
Evaluating the Efficacy of Pathways Parent-Mediated Early Autism Intervention on Social Attention and Language
A study testing Pathways Intervention and Parent Education Intervention (PEI) in people with Autism Spectrum Disorder, run by The University of Texas at Dallas at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the efficacy of Pathways parent-mediated early autism intervention (Pathways) and a parent education intervention (PEI) delivered to culturally and linguistically diverse families with children 12-42 months of age suspected of or diagnosed with autism. Read more about this study
- Who is it for?
- Ages 12 to 42 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Pathways Intervention and Parent Education Intervention (PEI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2022to 1 Feb 2025
- 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 42 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Caregivers and their children who
- are between 12-42 months old at the start of the study;
- diagnosed with or suspected of having autism
- have no other known neurological or genetic concerns or disorders;
- have a primary home language of English or Spanish;
- has an ASD diagnosis corroborated by the Autism Diagnostic Observation Schedule (ADOS-2) administered by study researchers;
- live in Dallas Texas within a 30-mile radius of the downtown location of the UTD/Callier Center for Communication Disorders.
Who cannot join
- anyone not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas/Callier Center for Communication Disorders
Dallas, Texas, 75235
About this study
Official title: Evaluating the Efficacy of Pathways Early Autism Intervention on Social Orienting, Joint Attention and Social Language: a Randomized Control Trial
The goal of this clinical trial is to compare the efficacy of Pathways parent-mediated early autism intervention (Pathways) and a parent education intervention (PEI) delivered to culturally and linguistically diverse families with children 12-42 months of age suspected of or diagnosed with autism.
Question 1: Is Pathways more effective than a PEI at (a) fostering the development of social orienting, joint attention, and social communication and language in children with a research diagnosis of autism and (b) relieving their parents' stress?
Read more
Question 2: Is the magnitude of the relationship between early and later developing attention greater in children whose parents receive Pathways compared to children whose parents receive PEI?
Question 3: Is the magnitude of the relationship between joint attention and social communication and language greater in children whose parents receive Pathways compared to children whose parents receive PEI?
Participants will be randomized into 24 weeks of Pathways or PEI. Participants will receive a battery of assessments to evaluate the child's cognitive, social attention, social communication, language, and adaptive functioning, and parental stress at four different time points spaced every 12 weeks from baseline to three-month follow-up.
Read the detailed description
This study aims to evaluate the efficacy of all ten units of Pathways parent-coaching early autism intervention. A limitation of our previous 12-week intervention research was that in 12 weeks, we could only assess efficacy for the first five Pathways units. The first five units focus on dyadic social skills (i.e., social orienting, mutual gaze, getting the social partner's attention, and mutual imitation). The last five Pathways units (units 6-10) build on these foundational skills and focus on facilitating triadic social skills (i.e., joint attention, social communication, and language). Joint attention is an essential component of social communication and provides the context for social communication and language. Therefore, it is vital to establish the efficacy of the entire Pathways program (i.e., all ten units) on the development of social orienting, joint attention, social communication, and language.
Aim 1: To identify the effectiveness of the entire Pathways program on (a) the development of social orienting, joint attention, and social communication and language in children with a research diagnosis of autism; and (b) relieving their parents' stress.
Aim 2: To identify the relationship between early social orienting and later joint attention, social communication, and language skills.
We hypothesize that Pathways will moderate the effect of (1) growth in social orienting after receiving 12 weeks of intervention and (2) growth in joint attention and social communication and language after receiving 24 weeks of intervention. Further, we hypothesize social orienting after 12 weeks of intervention is significantly related to joint attention at 24 weeks. Finally, we expect that joint attention at 24 weeks will be significantly related to language at 36 weeks (i.e., at a 3-month follow-up). In terms of parenting stress, we expect to find a significant effect of Pathways on decreasing parent stress during the first 12 weeks of intervention, followed by a plateau.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Pathways Intervention, Parent Education Intervention (PEI)
- Keywords
- Autism Intervention, parent mediated intervention, social orienting, joint attention, social development, social communication, language, parenting stress
- Medical subject headings
- Autism Spectrum Disorder, Communication, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathways InterventionBehavioural
Pathways-trained research clinicians will conduct 90-minute weekly coaching sessions with caregivers (in English or Spanish) in the family's home or other convenient location. Caregivers will receive a written and audio version of the program manual in English or Spanish, depending on the family's home language. Sessions will review information about autism, interactional strategies, and Applied Behavioral Analysis (ABA) techniques from the program manual, demonstrate intervention strategies, and provide caregivers with practice feedback and self-reflection.
Parent Education Intervention (PEI)Behavioural
Caregivers will access a 20-30-minute video lesson and associated handouts (in English or Spanish, depending on the parent's home language) every other week for 24 weeks. On the off week, the caregiver will meet with a trained clinician (in English or Spanish) for 30 minutes without the child. Lessons will cover autism, social attention delays, evidence-based interventions, self-regulation, talking with your child, playing with your child, principles of managing behavior, knowing your rights, and self-care. The first and last visit will occur in the family's home or another convenient location. All other visits will take place over Zoom videoconferencing software.
| Study group | Role | What they receive |
|---|---|---|
| Pathways Intervention | Experimental | Twenty-four weeks of a manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated early autism intervention that uses a coaching model. Receives: Behavioral: Pathways Intervention |
| Parent Education Intervention (PEI) | Active comparator | Twenty-four weeks of individual caregiver training without the child being present. Receives: Behavioral: Parent Education Intervention (PEI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in child social orienting
Assessors blind to group and time will code video recordings from two structured clinician-child interactions (CCI). Both CCIs will be recorded using an iPad or small video camera for a wide-angle view of the interaction and hidden camera eyeglasses worn by the clinician to capture the location and direction of the child's eye gaze. Change in the rate of social orienting (number of occurrences/total time engaged with the clinicians across the two structured interactions) will be measured.
Measured: Assessed for changes every 12 weeks from baseline to 36 weeks
Changes in child Joint attention
Assessors blind to group and time will code video recordings from two structured clinician-child interactions (CCI). Both CCIs will be recorded using an iPad or small video camera for a wide-angle view of the interaction and hidden camera eyeglasses worn by the clinician to capture the location and direction of the child's eye gaze. Change in the rate of joint attention (number of occurrences/total time engaged with the clinicians across the two structured interactions) will be measured.
Measured: Assessed for changes every 12 weeks from baseline to 36 weeks
Change in child social communication
Change in the raw scores obtained on the social, speech and symbolic composite of The Communication and Symbolic Behavior Scales- Developmental Profile (CSBS-DP) will be measured. Raw scores for the social, speech and symbolic composite range from 0-64, 0-54 and 0-53 respectively. The CSBS-DP is a direct assessment of early social communication.
Measured: Assessed for changes every 12 weeks from baseline to 36 weeks
Change in child language
Change in the raw scores obtained on The Preschool Language Scales 5th Edition (PLS-5) will be measured. The PLS-5 is a standardized measure of language.
Measured: Assessed for changes every 12 weeks from baseline to 36 weeks
change in intentional communication
Assessors blind to group and time will code video recordings from six minutes of a structured clinician-child interactions using the Early Communication Indicator (ECI). The ECI is a weighted measure of intentional communication.
Measured: Assessed for changes every 12 weeks from baseline to 36 weeks
Secondary outcomes (2)
Changes in parenting stress
Change in percentile scores obtained on Parenting Stress Index-4 (PSI-4) will be measured. PSI-4 is a standardized parent questionnaire on which parents rate agreement on 36 items using a five-point Likert scale.
Measured: Assessed for changes every 12 weeks from baseline to 36 weeks
changes in child adaptive functioning
Change in raw scores obtained on Vineland Adaptive Behavior Scales, Second Edition (Vineland II) will be measured. The Vineland II is a standardized parent interview to assess adaptive functioning.
Measured: Assessed for changes from baseline to 24 weeks and from 24-to-36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start27 Oct 2022
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Rollins, The University of Texas at Dallas
- Investigators
- Pamela R Rollins, Ed.D, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604326
- Sponsor's protocol ID
- UTD IRB 22 - 665
- Status last verified
- Aug 2024
- First submitted
- 27 Oct 2022
- Last updated
- 21 Mar 2025
- 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Pathways Early Autism Intervention on Social Orienting, Joint Attention and Social Language: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05604326
- Acronym / sponsor ID
- UTD IRB 22 - 665
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Intervention, parent mediated intervention, social orienting, joint attention, social development, social communication, language, parenting stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 3 Nov 2022 (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.
The goal of this clinical trial is to compare the efficacy of Pathways parent-mediated early autism intervention (Pathways) and a parent education intervention (PEI) delivered to culturally and linguistically diverse families with children 12-42 months of age suspected of or diagnosed with autism.
Question 1: Is Pathways more effective than a PEI at (a) fostering the development of social orienting, joint attention, and social communication and language in children with a research diagnosis of autism and (b) relieving their parents' stress?
Question 2: Is the magnitude of the relationship between early and later developing attention greater in children whose parents receive Pathways compared to children whose parents receive PEI?
Question 3: Is the magnitude of the relationship between joint attention and social communication and language greater in children whose parents receive Pathways compared to children whose parents receive PEI?
Participants will be randomized into 24 weeks of Pathways or PEI. Participants will receive a battery of assessments to evaluate the child's cognitive, social attention, social communication, language, and adaptive functioning, and parental stress at four different time points spaced every 12 weeks from baseline to three-month follow-up.
Detailed description
This study aims to evaluate the efficacy of all ten units of Pathways parent-coaching early autism intervention. A limitation of our previous 12-week intervention research was that in 12 weeks, we could only assess efficacy for the first five Pathways units. The first five units focus on dyadic social skills (i.e., social orienting, mutual gaze, getting the social partner's attention, and mutual imitation). The last five Pathways units (units 6-10) build on these foundational skills and focus on facilitating triadic social skills (i.e., joint attention, social communication, and language). Joint attention is an essential component of social communication and provides the context for social communication and language. Therefore, it is vital to establish the efficacy of the entire Pathways program (i.e., all ten units) on the development of social orienting, joint attention, social communication, and language.
Aim 1: To identify the effectiveness of the entire Pathways program on (a) the development of social orienting, joint attention, and social communication and language in children with a research diagnosis of autism; and (b) relieving their parents' stress.
Aim 2: To identify the relationship between early social orienting and later joint attention, social communication, and language skills.
We hypothesize that Pathways will moderate the effect of (1) growth in social orienting after receiving 12 weeks of intervention and (2) growth in joint attention and social communication and language after receiving 24 weeks of intervention. Further, we hypothesize social orienting after 12 weeks of intervention is significantly related to joint attention at 24 weeks. Finally, we expect that joint attention at 24 weeks will be significantly related to language at 36 weeks (i.e., at a 3-month follow-up). In terms of parenting stress, we expect to find a significant effect of Pathways on decreasing parent stress during the first 12 weeks of intervention, followed by a plateau.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pathways Intervention | Experimental | Behavioral: Pathways InterventionTwenty-four weeks of a manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated early autism intervention that uses a coaching model. |
| Parent Education Intervention (PEI) | Active comparator | Behavioral: Parent Education Intervention (PEI)Twenty-four weeks of individual caregiver training without the child being present. |
Who may qualify
- Ages
- 12 to 42 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Caregivers and their children who
- are between 12-42 months old at the start of the study;
- diagnosed with or suspected of having autism
- have no other known neurological or genetic concerns or disorders;
- have a primary home language of English or Spanish;
Key exclusion criteria (1 listed)
- anyone not meeting the inclusion criteria
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 |
|---|---|---|
| Pathways InterventionPathways-trained research clinicians will conduct 90-minute weekly coaching sessions with caregivers (in English or Spanish) in the family's home or other convenient location. Caregivers will receive a written and audio version of the program manual in English or Spanish, depending on the family's home language. Sessions will review information about autism, interactional strategies, and Applied Behavioral Analysis (ABA) techniques from the program manual, demonstrate intervention strategies, and provide caregivers with practice feedback and self-reflection. | Behavioural | Pathways Intervention |
| Parent Education Intervention (PEI)Caregivers will access a 20-30-minute video lesson and associated handouts (in English or Spanish, depending on the parent's home language) every other week for 24 weeks. On the off week, the caregiver will meet with a trained clinician (in English or Spanish) for 30 minutes without the child. Lessons will cover autism, social attention delays, evidence-based interventions, self-regulation, talking with your child, playing with your child, principles of managing behavior, knowing your rights, and self-care. The first and last visit will occur in the family's home or another convenient location. All other visits will take place over Zoom videoconferencing software. | Behavioural | Parent Education Intervention (PEI) |
Primary outcome
Changes in child social orienting
Time frame: Assessed for changes every 12 weeks from baseline to 36 weeks
Assessors blind to group and time will code video recordings from two structured clinician-child interactions (CCI). Both CCIs will be recorded using an iPad or small video camera for a wide-angle view of the interaction and hidden camera eyeglasses worn by the clinician to capture the location and direction of the child's eye gaze. Change in the rate of social orienting (number of occurrences/total time engaged with the clinicians across the two structured interactions) will be measured.
Changes in child Joint attention
Time frame: Assessed for changes every 12 weeks from baseline to 36 weeks
Assessors blind to group and time will code video recordings from two structured clinician-child interactions (CCI). Both CCIs will be recorded using an iPad or small video camera for a wide-angle view of the interaction and hidden camera eyeglasses worn by the clinician to capture the location and direction of the child's eye gaze. Change in the rate of joint attention (number of occurrences/total time engaged with the clinicians across the two structured interactions) will be measured.
Change in child social communication
Time frame: Assessed for changes every 12 weeks from baseline to 36 weeks
Change in the raw scores obtained on the social, speech and symbolic composite of The Communication and Symbolic Behavior Scales- Developmental Profile (CSBS-DP) will be measured. Raw scores for the social, speech and symbolic composite range from 0-64, 0-54 and 0-53 respectively. The CSBS-DP is a direct assessment of early social communication.
Change in child language
Time frame: Assessed for changes every 12 weeks from baseline to 36 weeks
Change in the raw scores obtained on The Preschool Language Scales 5th Edition (PLS-5) will be measured. The PLS-5 is a standardized measure of language.
change in intentional communication
Time frame: Assessed for changes every 12 weeks from baseline to 36 weeks
Assessors blind to group and time will code video recordings from six minutes of a structured clinician-child interactions using the Early Communication Indicator (ECI). The ECI is a weighted measure of intentional communication.
2 secondary outcomes
Changes in parenting stress
Time frame: Assessed for changes every 12 weeks from baseline to 36 weeks
changes in child adaptive functioning
Time frame: Assessed for changes from baseline to 24 weeks and from 24-to-36 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 21 Mar 2025.
- 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.
Pamela R Rollins, Ed.D principal investigator
The University of Texas at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathways Intervention and Parent Education Intervention (PEI) in people with Autism Spectrum Disorder, run by The University of Texas at Dallas 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 7 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 21 Mar 2025. 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?
Changes in child social orienting (time frame: Assessed for changes every 12 weeks from baseline to 36 weeks). The study lists 5 primary outcomes in all. 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 21 Mar 2025.