Pathways Mutual Gaze Protocol for Autism

Overseen By Chrislove Ulysse

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Dallas

Disqualifiers: Neurological, Genetic disorders, others

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

Compensation: Varies

Number of Visits: 15

Duration: 15 weeks

80 Participants Needed

Trial Summary

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 Pathways Early Intervention (Pathways), is the key to helping improve social communication, language, and everyday skills in young children (16-30 months old) who are at high risk for autism, particularly those from diverse cultural and language backgrounds. What Will Happen: Researchers will compare two versions of the Pathways Intervention: * Version 1: Includes mutual gaze strategies. * Version 2: Does not include mutual gaze strategies. What to Expect: Participants will: * Attend 12 sessions of Pathways Intervention, each lasting 1.5 hours (or 15 weeks if there are cancellations). * Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways.

Do I need to stop my child's current medications for this trial?

The trial protocol does not specify whether participants must stop taking current medications.

What data supports the idea that Pathways Mutual Gaze Protocol for Autism is an effective treatment?

The available research does not provide any specific data or evidence supporting the effectiveness of the Pathways Mutual Gaze Protocol for Autism. The studies mentioned focus on early intervention for psychosis, traumatic brain injury management, and pathways to mental health care, but none of them address the Pathways Mutual Gaze Protocol or its impact on autism. Therefore, there is no data in the provided information to support the effectiveness of this treatment for autism. ^{1 2 3 4 5}

What safety data is available for the Pathways Mutual Gaze Protocol for Autism?

The provided research does not specifically mention safety data for the Pathways Mutual Gaze Protocol or its related interventions. However, it highlights the importance of monitoring and reporting adverse events in pediatric psychosocial interventions. The need for comprehensive assessment and reporting of adverse events is emphasized to ensure the safety and effectiveness of psychological treatments for children. This suggests that while specific safety data for the Pathways interventions may not be available, there is a recognized need for such data in similar interventions. ^{6 7 8 9 10}

Is Pathways Parent Mediated Intervention a promising treatment for autism?

Yes, Pathways Parent Mediated Intervention is a promising treatment for autism. It has been shown to improve social interaction, eye contact, and communication in children with autism. Parents find it beneficial and easy to use in daily life. ^{11 12 13 14 15}

Research Team

Pamela Rollins, EdD

Principal Investigator

University of Texas at Dallas

Eligibility Criteria

This trial is for young children aged 16-30 months who are at high risk for autism and have social challenges, with parents fluent in English. It's aimed at those living within 30 miles of the Callier Center Dallas without other neurological or genetic disorders.

Inclusion Criteria

My child is between 16 and 30 months old.

My child has a social disability score of 7 or lower and faces social challenges.

I am fluent in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive 12 sessions of Pathways Intervention, each lasting 1.5 hours, over approximately 15 weeks

15 weeks

12 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 of the intervention, including social communication and adaptive functioning

12-15 weeks

1 visit (in-person)

Treatment Details

Interventions

• Pathways Parent Mediated Intervention
• Pathways Parent Mediated Intervention without Mutual Gaze

Trial Overview The study tests two versions of Pathways Early Intervention to improve social skills in kids suspected of autism: one includes mutual gaze techniques, while the other doesn't. Participants will attend sessions and have developmental check-ups before, after, and three months post-intervention.

Participant Groups

Group I: Pathways with a Mutal Gaze Protocol Experimental Treatment 1 Intervention

12 90-minute sessions (or 15 weeks, whichever comes first) of Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated intervention (research version). Pathways uses a coaching model.

Group II: Pathways without Mutual Gaze Protocol Active Control 1 Intervention

12 90-minute sessions (or 15 weeks, whichever comes first) of Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated intervention (research version) without the Mutual Gaze protocol. Pathways uses a coaching model.

Pathways Parent Mediated Intervention is already approved in United States for the following indications:

Approved in United States as Pathways Early Autism Intervention for:

• Improvement of social communication skills in young children suspected of autism

Who Is Running the Clinical Trial?

The University of Texas at Dallas

Lead Sponsor

Trials

71

Recruited

108,000+

Texas Higher Education Coordinating Board

Collaborator

Trials

4

Recruited

390+

Findings from Research

Early intervention strategies, including phase-specific treatments and specialized teams, show potential benefits in preventing psychosis in individuals with prodromal symptoms, as evidenced by a small Australian trial where participants receiving low-dose risperidone and cognitive behavioral therapy were significantly less likely to develop psychosis compared to those receiving standard care (RR 0.27).

However, the overall evidence is inconclusive, with many studies showing mixed results, such as a large Scandinavian study indicating that integrated treatment improved global functioning but did not significantly reduce relapse rates over two years, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early intervention for psychosis. Marshall, M., Rathbone, J.[2020]

A small trial with 59 participants showed that a phase-specific intervention combining low-dose risperidone and cognitive behavioral therapy significantly reduced the likelihood of developing psychosis in individuals with prodromal symptoms at a 6-month follow-up, compared to standard care.

Another trial with 83 participants indicated that family therapy combined with outpatient care led to significantly lower admission rates for individuals experiencing their first episode of psychosis, suggesting that phase-specific treatments can improve outcomes, although the applicability of the findings is uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Intervention for psychosis. Marshall, M., Lockwood, A.[2018]

Implementing a standardized care pathway for managing severe traumatic brain injury (TBI) in children, known as the PEGASUS pathway, significantly improved adherence to clinical guidelines from 64% to 80% over 18 months.

Higher adherence to TBI management guidelines is associated with better discharge survival rates, highlighting the importance of following established protocols in pediatric trauma care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and implementation of a standardized pathway in the Pediatric Intensive Care Unit for children with severe traumatic brain injuries. Rakes, L., King, M., Johnston, B., et al.[2022]

Young people accessing a specialist youth mental health service in Norfolk experienced an average of 3.74 years and 5.53 different pathways before receiving appropriate care, indicating significant delays in accessing treatment.

Those with a history of mental health issues had shorter pathways to care, suggesting that prior experiences may influence the speed of accessing services, while longer pathways were associated with poorer functioning outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathways to care of young people accessing a pilot specialist youth mental health service in Norfolk, United Kingdom. Hodgekins, J., Clarke, T., Cole, H., et al.[2021]

A one-year community awareness program aimed at improving knowledge and referral pathways for early intervention services (EIS) in first episode psychosis showed significant improvements in staff attitudes and knowledge, but did not reduce the duration of untreated psychosis (DUP) or improve referral pathways.

Despite training 367 staff across 41 workshops, the program did not lead to a noticeable increase in direct referrals to EIS from community organizations, indicating that barriers such as stigma and lack of awareness about early psychosis symptoms still hinder access to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a community awareness programme to reduce delays in referrals to early intervention services and enhance early detection of psychosis. Lloyd-Evans, B., Sweeney, A., Hinton, M., et al.[2023]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

Most parents were unaware of the adverse events following immunization (AEFI) surveillance system but expressed interest in participating, indicating a potential for increased reporting through parental involvement.

Parents preferred online reporting over paper forms due to its convenience and speed, and they would be more likely to report AEFI if the website was endorsed by their vaccine provider and offered secure, interactive features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Factors determining utilization of a Web site by parents in order to report side effects of vaccines]. Kimpton, A., Dubé, E., Sauvageau, C., et al.[2021]

The safety of psychological interventions is critical, as adverse events (AEs) can occur and must be carefully evaluated to ensure that these interventions do not cause harm before being deemed beneficial.

There is a pressing need for standardized protocols for assessing and reporting AEs in psychological interventions to improve transparency, consistency, and ultimately enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? Purgato, M., Cortese, S.[2023]

This study will analyze adverse events in psychotherapy for youth with OCD by including at least 128 participants aged 8-17, comparing family-based cognitive behavioral therapy (FCBT) and family-based psychoeducation and relaxation training (FPRT).

The mixed methods approach will combine quantitative assessments of adverse events with qualitative interviews to better understand their nature and causes, aiming to improve the safety and effectiveness of psychotherapy for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. Pretzmann, L., Christensen, SH., Bryde Christensen, A., et al.[2023]

A family-based reporting system for adverse events in pediatric inpatients did not significantly increase the reporting rates by healthcare providers, indicating a disconnect between family and staff perceptions of safety events.

Out of 321 events reported by families, 48% were legitimate safety concerns, highlighting that families can provide valuable insights into patient safety that are often overlooked by healthcare staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification by families of pediatric adverse events and near misses overlooked by health care providers. Daniels, JP., Hunc, K., Cochrane, DD., et al.[2022]

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]

A 12-week parent training program based on the Early Start Denver Model (ESDM) led to an increase in the use of various intervention strategies by five mothers of young children with autism, indicating the program's effectiveness in enhancing parental skills.

The study revealed that different ESDM strategies had varying impacts on children's engagement and language development, suggesting that parent training should be personalized to better meet individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining parent use of specific intervention techniques during a 12-week training program based on the Early Start Denver Model. Waddington, H., van der Meer, L., Sigafoos, J., et al.[2020]

Early intervention for children with autism spectrum disorder (ASD) has seen significant growth, focusing primarily on child outcomes like language acquisition, but there is a need to also consider family outcomes such as quality of life and parent self-efficacy.

Parent buy-in is crucial for the success of parent-mediated interventions, highlighting the importance of evaluating and improving family outcomes to ensure the sustainability and effectiveness of these interventions in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remembering parents in parent-mediated early intervention: An approach to examining impact on parents and families. Wainer, AL., Hepburn, S., McMahon Griffith, E.[2019]

The Pathways Early Autism Intervention program effectively improved eye contact, social engagement, and verbal reciprocity in four boys with autism spectrum disorder, as measured by a single-subject design with multiple baselines.

Parents found the intervention beneficial and easy to integrate into their daily routines, highlighting its potential for broader application in state-funded early intervention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-based early intervention program for toddlers with autism spectrum disorders. Rollins, PR., Campbell, M., Hoffman, RT., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Early intervention for psychosis. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Early Intervention for psychosis. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Development and implementation of a standardized pathway in the Pediatric Intensive Care Unit for children with severe traumatic brain injuries. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Pathways to care of young people accessing a pilot specialist youth mental health service in Norfolk, United Kingdom. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of a community awareness programme to reduce delays in referrals to early intervention services and enhance early detection of psychosis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Factors determining utilization of a Web site by parents in order to report side effects of vaccines]. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

Identification by families of pediatric adverse events and near misses overlooked by health care providers. [2022]

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

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

12. Netherlands pubmed.ncbi.nlm.nih.gov

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

13. England pubmed.ncbi.nlm.nih.gov

Examining parent use of specific intervention techniques during a 12-week training program based on the Early Start Denver Model. [2020]

14. England pubmed.ncbi.nlm.nih.gov

Remembering parents in parent-mediated early intervention: An approach to examining impact on parents and families. [2019]

15. England pubmed.ncbi.nlm.nih.gov

A community-based early intervention program for toddlers with autism spectrum disorders. [2019]