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

Trial Summary

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 data supports the effectiveness of the treatment Culturally and Linguistically Responsive Pathways 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 in children with autism. Specifically, brief training in Pivotal Response Treatment (PRT) has been shown to enhance communication and adaptive skills in young children with autism, suggesting that culturally responsive approaches can be beneficial. ^{1 2 3 4 5}

Is the Parent-Mediated Intervention for Autism safe for humans?

The available research does not provide specific safety data for the Parent-Mediated Intervention for Autism, but it focuses on cultural and linguistic adaptations and effectiveness in improving social and communication skills in children with autism. ^{1 2 3 4 6}

How is the Parent-Mediated Intervention for Autism unique compared to other treatments?

This treatment is unique because it is culturally and linguistically tailored to meet the needs of diverse families, particularly Hispanic and Latin American populations, which helps improve engagement and effectiveness. It also involves parents directly in the intervention process, which can be beneficial in resource-limited settings where professional services may be delayed or inaccessible. ^{1 2 3 4 7}

What is the purpose of this trial?

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 Linguistically Responsive adaptation of Pathways Early Intervention (CLR-Pathways) is the key to improving social communication, language, and everyday skills in young (18-42 months) Hispanic autistic children experiencing low income. What Will Happen: Researchers will compare two versions of CLR-Pathways. * Version 1: Includes mutual gaze strategies. * Version 2: Does not include mutual gaze strategies. What to Expect: Participants will: * Attend 16 sessions (or 18 weeks if there are cancellations) of Pathways Intervention, each lasting 1.5 hours. * Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Examining Cultural and Linguistic Sensitivity of Pathways Early Autism Intervention with Hispanic Families. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Recommendations for Diversifying Racial and Ethnic Representation in Autism Intervention Research: A Crossover Review of Recruitment and Retention Practices in Pediatric Mental Health. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Cultural Adaptations to Parent-Mediated Autism Spectrum Disorder Interventions for Latin American Families: A Scoping Review. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Helping Optimize Language Acquisition (HOLA) Online Parent Training Modules for Latinx Parents of Toddlers at Risk for ASD: Protocol for a Pilot Funded by the Organization for Autism Research. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Overcoming Language Barriers between Interventionists and Immigrant Parents of Children with Autism Spectrum Disorder. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Mutual Gaze: An Active Ingredient for Social Development in Toddlers with ASD: A Randomized Control Trial. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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