Parent-Mediated Intervention for Autism

Recruiting at 2 trial locations

Overseen By Erin E Kosloski, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Dallas

Disqualifiers: Non-Hispanic, Income > 200% poverty, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

Duration: 18 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a parent-guided technique called the "mutual gaze procedure" can enhance social communication, language, and daily skills in young Hispanic children with autism from low-income families. The study will compare two groups: one using mutual gaze strategies and one not using them, both within the Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention program. It includes 16 sessions over 18 weeks, plus three developmental check-ups. Eligible children have been diagnosed with autism, come from low-income Hispanic families, and have English or Spanish as their primary home language.

As an unphased trial, this study offers a unique opportunity to contribute to innovative autism research that could benefit children in similar communities.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the mutual gaze procedure is safe for young Hispanic autistic children?

A previous study found that Pathways, a program where parents assist their autistic children, was culturally and linguistically sensitive for Hispanic families with young autistic children. Although specific safety data is unavailable, families have responded positively, indicating it is well-received.

The program involves parents, helping them feel more comfortable and better understand the process. While the research does not mention any negative effects, the emphasis on cultural understanding and parent involvement fosters a safe and supportive environment. As this is not a medication-based program, physical side effects are not expected. Participants can anticipate a nurturing and educational experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they focus on a parent-mediated intervention that is culturally and linguistically responsive, which is unique compared to standard autism therapies often less tailored to cultural nuances. The intervention involves coaching parents to engage with their children using a Naturalistic Developmental Behavioral Intervention (NDBI) approach, but with a twist: one version includes a mutual gaze protocol, which could enhance social interaction skills. By incorporating mutual gaze, this treatment aims to foster deeper connections and communication between parents and children, potentially opening new pathways for social development in autism.

What evidence suggests that this trial's treatments could be effective for improving social communication, language, and everyday skills in young Hispanic autistic children?

Research has shown that parent-led programs tailored to different cultures can be very effective for diverse families. These programs help improve skills like joint attention, which involves focusing together on an object or activity, and language development. In this trial, participants will be assigned to one of two treatment arms. One arm will receive the Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention with a Mutual Gaze Protocol, which has been proven to enhance eye contact, social interaction, and conversational ability. The other arm will receive the same intervention without the Mutual Gaze Protocol. This program is designed to be culturally and linguistically sensitive, making it especially helpful for Hispanic families with young autistic children. The mutual gaze technique, which involves making eye contact, is believed to further improve social communication and language skills. ^{1 2 3 5 6}

Who Is on the Research Team?

Pamela Rollins, EdD

Principal Investigator

University of Texas at Dallas

Are You a Good Fit for This Trial?

This trial is for young Hispanic children aged 18-42 months diagnosed with Autism or Autism Spectrum Disorder, who are from low-income families. The study specifically seeks to include participants that reflect the cultural and linguistic background of the Hispanic community.

Inclusion Criteria

Children must receive a Calibrated Severity Score (CSS) of 4 or higher on the Autism Diagnostic Observational Schedule-2 (ADOS-2) administered by a qualified bilingual assessment associate

I am from a low-income Hispanic family, earning less than 200% of the federal poverty level.

My child is between 18 and 42 months old.

Exclusion Criteria

English or Spanish is not the primary language spoken in my home.

Children who are from a family that is not Hispanic and/or does not have an income-to-needs ratio of < 200% of the federal poverty level, determined by their household size

My child is not between 18 and 42 months old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants attend 16 sessions of Pathways Intervention over approximately 18 weeks, with each session lasting 1.5 hours.

18 weeks

16 sessions (in-person or at a convenient location)

Post-Intervention Assessment

Participants undergo assessments to evaluate the immediate effects of the intervention.

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for long-term effects and undergo assessments 12-15 weeks after completing the intervention.

12-15 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention with Mutual Gaze
• Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze

Trial Overview

The study is testing two versions of a culturally adapted early intervention called CLR-Pathways for autistic children. One version includes 'mutual gaze' techniques aimed at improving social communication, while the other does not.

How Is the Trial Designed?

Group I: Culturally and Linguistically Responsive Pathways with a Mutual Gaze Protocol Experimental Treatment 1 Intervention

16 90-minute sessions (or 18 weeks, whichever comes first) of a Culturally and Linguistically Responsive adaptation of the Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI; research version). Pathways is parent-mediated and uses a coaching model.

Group II: Culturally and Linguistically Responsive Pathways without Mutual Gaze Protocol Active Control 1 Intervention

16 90-minute sessions (or 18 weeks, whichever comes first) of a Culturally and Linguistically Responsive adaptation of the Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI; research version) without the Mutual Gaze Protocol. Pathways is parent-mediated and uses a coaching model.

Who Is Running the Clinical Trial?

The University of Texas at Dallas

Lead Sponsor

Trials

71

Recruited

108,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Catholic Charities of Dallas

Collaborator

Trials

1

Recruited

200+

University of Kansas

Collaborator

Trials

157

Recruited

332,000+

Catholic Charities

Collaborator

Trials

5

Recruited

4,100+

Published Research Related to This Trial

In a study of 42 children with Autism Spectrum Disorder (ASD) who received a 3-month parent-mediated intervention, all participants showed significant improvements in symptom severity and adaptive functioning at both 3-month and 18-month follow-ups.

At the 18-month follow-up, 16.7% of the children achieved the 'best possible' outcome, with scores indicating they no longer qualified for an ASD diagnosis, highlighting the effectiveness of early intervention in altering developmental trajectories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of children with ASD - Preliminary findings from a 18 month follow up study. Manohar, H., Kandasamy, P.[2021]

The Pathways intervention, which includes a mutual gaze component, significantly improved social measures, communicative synchrony, and adaptive functioning in children compared to standard services-as-usual (SAU) over a 12-week period with 78 families involved.

Mutual gaze was identified as an important factor contributing to social and communication development, highlighting its potential role in early childhood interventions for autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mutual Gaze: An Active Ingredient for Social Development in Toddlers with ASD: A Randomized Control Trial. Rollins, PR., De Froy, A., Campbell, M., et al.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT06733584

Meeting the Needs of Young Hispanic Autistic Children

Purpose of the Study: The goal of this clinical trial is to find out if a technique called the "mutual gaze procedure" used in a Culturally and ...

2.

withpower.com

withpower.com/trial/phase-autistic-disorder-6-2025-eea69

Parent-Mediated Intervention for Autism

Research shows that culturally adapted parent-mediated interventions can be effective for diverse families, improving skills like joint attention and language ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10159226/

Examining Cultural and Linguistic Sensitivity of Pathways ...

Conclusion: Pathways demonstrated strengths regarding cultural and linguistic sensitivity for Hispanic families with young autistic children.

4.

pathwaysndbi.com

pathwaysndbi.com/pathways-research/

Pathways Research

The Pathways Parent Training Program was shown to be effective for the measures of eye contact, social engagement, and verbal reciprocity. Parents perceived the ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9123830/

Reexamining Pathways Early Autism Intervention in ...

We reexamined the efficacy of Pathways early autism intervention using generalized measures of social communication and language skills.

6.

mdpi.com

mdpi.com/2227-9032/12/23/2381

Parent-Mediated Autism Intervention Through a Culturally ...

Conclusions: This study suggests that culturally informed parent-mediated autism intervention coupled with parent coaching positively affects family outcomes ...