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

256 Participants Needed

Trial Summary

What is the purpose of this trial?

A randomized controlled trial will be conducted to determine the effects of an adapted family-centered autism transition intervention called Transitioning Together/Juntos en la Transición on meaningful outcomes for families. The study will occur in a safety net hospital setting. The adapted version of this multi-family group psychoeducation intervention is delivered across one individual family joining session and four 2.5 hour multi-family group sessions. The parent and youth groups are held in separately, at the same time.

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 Transitioning Together (TT) / Juntos en la Transicion (JET) for autism?

Research shows that the Transitioning Together program helps reduce family stress and improve social interactions for adolescents with autism. Parents also reported feeling less depressed and better at solving problems after participating in the program. ^{1 2 3 4 5}

Is the Family Support Program for Autism, also known as Transitioning Together, safe for participants?

The Transitioning Together program has been implemented in various settings and received positive feedback from families, with no reported safety concerns. Participants have reported improvements in family distress and social functioning, suggesting it is generally safe for use. ^{2 4 5 6 7}

How is the Transitioning Together treatment unique for autism?

Transitioning Together is unique because it is a multi-family group psychoeducation program specifically designed to reduce family stress and improve social interactions for adolescents with autism and their families. Unlike other treatments, it focuses on the family environment and provides a platform for families to interact and support each other during the transition to adulthood. ^{1 2 4 8 9}

Research Team

Jocelyn L Kuhn, PhD

Principal Investigator

Emory School of Medicine

Mei L Elansary, MD, MD

Principal Investigator

Boston Medical Center, Pediatrics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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 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 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]

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]

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]

References

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

The family context of autism spectrum disorders: influence on the behavioral phenotype and quality of life. [2021]

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

Evaluation of the effectiveness of an online transition planning program for adolescents on the autism spectrum: trial protocol. [2020]

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

Transitioning youth with autism spectrum disorders and other special health care needs into adult primary care: A provider survey. [2021]

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

Transitioning Together: A Multi-family Group Psychoeducation Program for Adolescents with ASD and Their Parents. [2019]

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

Process Evaluation of the BOOST-A™ Transition Planning Program for Adolescents on the Autism Spectrum: A Strengths-Based Approach. [2019]

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

Implementation of a multi-family autism transition program in the high school setting. [2022]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

Disrupted Care Continuity: Testing Associations between Social Networks and Transition Success for Children with Autism. [2022]

8. England 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. [2022]

9. Egypt 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. [2023]