Family Support Program for Autism

Overseen By Mei L Elansary, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Non-English/Spanish speakers, Independent living, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a program called Transitioning Together (also known as Juntos en la Transicion), which includes both individual and group sessions, can assist families of autistic youth in navigating the transition to adulthood. The study will compare this program to usual care options to assess any differences in outcomes for families. Conducted at a safety net hospital, sessions are available in both English and Spanish. Families with autistic teens or young adults aged 14-21, who live at home and have been seen at a specific hospital since 2015, might be suitable candidates. As an unphased trial, this study provides families with a unique opportunity to explore new support strategies during a crucial transition period.

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 Transitioning Together program is safe for families?

Research shows that the "Transitioning Together" program helps families manage changes related to autism. This program combines learning and support for both individuals and their families. It includes individual and group sessions, focusing on helping families handle the challenges of autism.

Programs like this generally have a good safety record. They are well-tolerated because they do not involve medication or medical procedures. Instead, they provide support through organized sessions and are unlikely to cause harm. Previous studies on similar programs have not reported any negative effects.

In summary, current research indicates that the "Transitioning Together" program is safe. It focuses on education and family support, minimizing any risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard care options for autism, which often focus on medical or behavioral therapies, the Transitioning Together program offers a unique approach by providing structured family support. This intervention, available in both English and Spanish, emphasizes the involvement of families in the transition process, which is crucial for adolescents with autism as they move into adulthood. Researchers are excited about this program because it aims to empower families with strategies and resources, potentially leading to better long-term outcomes for individuals with autism.

What evidence suggests that this trial's treatments could be effective for autism?

Research shows that the Transitioning Together (TT) program, which participants in this trial may receive, benefits families with teenagers on the autism spectrum. Participants have expressed high satisfaction, highlighting the importance of connecting with other families in similar situations. Studies have found that this program reduces family stress and improves overall quality of life. The program supports families during the challenging transition to adulthood, providing structured guidance and shared experiences that ease this period. ^{1 2 5 6 7}

Who Is on the Research Team?

Mei L Elansary, MD, MD

Principal Investigator

Boston Medical Center, Pediatrics

Jocelyn L Kuhn, PhD

Principal Investigator

Emory School of Medicine

Are You a Good Fit for This Trial?

This trial is for families with a youth aged 14-21 diagnosed with autism, who have visited BMC since 2015 and are in high school or specialized schooling. Parents must be comfortable with English/Spanish and live with the youth.

Inclusion Criteria

For youth: Currently live at home with a parent/legal guardian

I am a parent and I am at least 21 years old.

My parent or legal guardian meets the required criteria.

Exclusion Criteria

The autistic youth currently resides independently, in supported housing, or with a foster family or other Department of Children and Families (DCF) placement

Both my child and I agree to participate in the study.

My family's primary language at home is neither English nor Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Transitioning Together intervention, consisting of one individual family joining session and four 2.5-hour multi-family group sessions

5 weeks

5 sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in quality of life, transition readiness, and other outcomes

3-12 months

What Are the Treatments Tested in This Trial?

Interventions

• Transitioning Together (TT) / Juntos en la Transicion (JET)
• Usual autism transition care

Trial Overview The study tests 'Transitioning Together/Juntos en la Transición,' an intervention involving one family session and four group sessions to improve outcomes for families dealing with autism transitions.

How Is the Trial Designed?

Group I: Transitioning Together Experimental Treatment 1 Intervention

Participants in this arm will receive the Transitioning Together intervention in English or Spanish either at BMC, at BMC's Supporting Parents \& Resilient Kids (SPARK) Center or on BMC Zoom.

Group II: Usual Care Active Control 1 Intervention

Participants in this arm will receive a referral to usual transition-related care through the BMC Developmental and Behavioral Pediatrics (DBP) clinic/the BMC Autism Program.

Transitioning Together (TT) / Juntos en la Transicion (JET) is already approved in United States for the following indications:

Approved in United States as Transitioning Together for:

• Supporting families of adolescents on the autism spectrum in transitioning to adulthood

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Deborah Munroe Noonan Memorial Research Fund

Collaborator

Trials

6

Recruited

390+

Published Research Related to This Trial

The BOOST-A™ program is an online interactive transition planning tool designed specifically for adolescents on the autism spectrum, aiming to enhance their self-determination and support successful transitions from high school to further education or employment.

The trial will assess the program's effectiveness by comparing outcomes in self-determination and other related factors between participants using BOOST-A™ and those receiving regular transition planning practices, with data collected at baseline and after 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the effectiveness of an online transition planning program for adolescents on the autism spectrum: trial protocol. Hatfield, M., Falkmer, M., Falkmer, T., et al.[2020]

The BOOST-A™ online transition planning program was positively received by adolescents with autism (n=33) and their parents (n=39), highlighting its effectiveness in helping participants take actionable steps towards future planning.

Key benefits included empowering adolescents by focusing on their strengths and providing guidance through a 'champion,' which facilitated clearer planning and overcame initial inertia in transition processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process Evaluation of the BOOST-A™ Transition Planning Program for Adolescents on the Autism Spectrum: A Strengths-Based Approach. Hatfield, M., Falkmer, M., Falkmer, T., et al.[2019]

The study evaluated an 8-week psychoeducation program called Transitioning Together for families of adolescents with Autism Spectrum Disorder (ASD), involving 41 participants in a randomized waitlist control design.

Results showed significant improvements in parental depressive symptoms and problem-solving skills, as well as enhanced social interactions for adolescents in the intervention group, indicating the program's potential effectiveness in supporting families during the transition to adulthood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitioning Together: A Multi-family Group Psychoeducation Program for Adolescents with ASD and Their Parents. DaWalt, LS., Greenberg, JS., Mailick, MR.[2019]

The 'Transitioning Together' psychoeducation program was developed to help reduce family stress and improve the quality of life for families with adolescents who have autism, highlighting its potential efficacy in supporting these families.

A case study demonstrated that the program effectively reduced family stress and enhanced the overall family environment, suggesting positive outcomes for families involved in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The family context of autism spectrum disorders: influence on the behavioral phenotype and quality of life. Smith, LE., Greenberg, JS., Mailick, MR.[2021]

The transition from pediatric to adult care for youth with autism spectrum disorders is often poorly coordinated, which can negatively impact their long-term health outcomes.

A survey study revealed that both pediatric and adult healthcare providers face challenges in implementing best practices for this transition, indicating a need for improved medical coordination and additional training resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitioning youth with autism spectrum disorders and other special health care needs into adult primary care: A provider survey. Ames, JL., Massolo, ML., Davignon, MN., et al.[2021]

The BOOST-A™ program, designed for adolescents on the autism spectrum, showed promising results in enhancing specific areas of self-determination and career exploration, particularly at home, based on a quasi-randomized controlled trial with 94 participants over 12 months.

While the program did not significantly improve overall self-determination or career planning at school, it suggests potential benefits for career readiness, indicating a need for further research to explore its effectiveness in post-secondary education and employment contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the BOOST-A™ online transition planning program for adolescents on the autism spectrum: a quasi-randomized controlled trial. Hatfield, M., Falkmer, M., Falkmer, T., et al.[2022]

The Transitioning Together intervention, aimed at supporting families of adolescents with autism during their transition to adulthood, was successfully implemented in 17 out of 30 high schools, indicating its potential for real-world application.

Factors such as higher community socioeconomic status and better pre-existing family involvement and transition planning were key predictors of successful implementation, although schools faced challenges in maintaining session structure and collecting family feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a multi-family autism transition program in the high school setting. Kuhn, J., Szidon, K., Kraemer, B., et al.[2022]

The study highlights that strong trust among team members in the team-around-the-child (TAC) network is significantly linked to successful school transitions for children with autism from lower-income families.

Collaborative problem-solving within the TAC may also play a role, but the emphasis on trust suggests that fostering positive relationships among parents, school staff, and community providers is crucial for minimizing disruptions in care during school transitions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disrupted Care Continuity: Testing Associations between Social Networks and Transition Success for Children with Autism. Hassrick, EM., Shih, W., Nuske, HJ., et al.[2022]

Family caregivers of adolescents and young adults with autism spectrum disorders (ASD) identified five key areas for improving services: providing clear guidance on available services, enhancing access to these services, addressing unmet needs, increasing autism education for families and society, and fostering strong relationships with families.

These insights were gathered from a study involving 174 family caregivers, highlighting the importance of caregiver perspectives in shaping effective support systems for youth with ASD transitioning to adulthood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Don't Promise Something You can't Deliver:" Caregivers' Advice for Improving Services to Adolescents and Young Adults with Autism. Berg, KA., Ishler, KJ., Lytle, S., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05599711

NCT05599711 | Transitioning Together Boston A randomized controlled trial will be conducted to determine the effects of an adapted family-centered autism transition intervention called ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5762411/

Transitioning Together: A Multi-Family Group ... Parents reported satisfaction with the program and particularly valued the opportunity to interact with other families. Keywords: autism spectrum disorder, ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05599711/transitioning-together-boston

Transitioning Together Boston | Clinical Research Trial ... A randomized controlled trial will be conducted to determine the effects of an adapted family-centered autism transition intervention called Transitioning ...

4. files.eric.ed.gov files.eric.ed.gov/fulltext/EJ1333681.pdf

Implementation of a multi-family autism transition program in ... Transitioning Together is an intervention that supports families of adolescents on the autism spectrum as they prepare for the transition to adulthood. While it ...

5. withpower.com withpower.com/trial/phase-relations-family-11-2022-2453e

Family Support Program for Autism The 'Transitioning Together' psychoeducation program was developed to help reduce family stress and improve the quality of life for families with adolescents ...

6. trialx.com trialx.com/clinical-trials/listings/242499/transitioning-together-boston/

Transitioning Together Boston | Clinical Research Trial ... ... Transitioning Together/Juntos en la Transición on meaningful outcomes for families. The study will occur in a safety net hospital setting.

7. clinicaltrial.be clinicaltrial.be/en/details/77124?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Transitioning Together Boston Data will be abstracted from the electronic medical record on how many visits each family completes with a BMC Autism Program Transition/Resource Specialist or ...