STEPS Program for Autism

Overseen By Nicole Powell, PHD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama, Tuscaloosa

Disqualifiers: Suicidal/homicidal intent

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

Compensation: Varies

Number of Visits: 14

Duration: 14 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called STEPS, which aims to help young adults with autism spectrum disorder (ASD) become more independent. The research evaluates the program's effectiveness when community agencies deliver it. Participants will either receive STEPS counseling, which includes 14 sessions focused on adult independence skills, or continue with their usual services (referred to as Services as Usual, SAU). This trial may suit those aged 16-25 with a confirmed ASD diagnosis who have a caregiver or parent to assist with assessments. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches for enhancing independence in young adults with ASD.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the STEPS Program is safe for emerging adults with autism?

Research has shown that the STEPS program has been used with young adults with autism in community settings. One study involved 24 participants who took part in the program through a local agency. The program aims to develop skills for independent living, and no serious side effects or harm were reported from these sessions.

Although the STEPS program is not a drug or medication, and no approved medicines exist for the main symptoms of autism, behavioral programs like STEPS are generally considered safe. The program focuses on skills that assist with everyday life, emphasizing learning and support rather than medical treatment.

In summary, the STEPS program appears safe and well-received based on past use. Participants might find it helpful for building skills without worrying about negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STEPS Program for Autism because it focuses on building adult independence skills through a 14-session counseling program. Unlike standard treatments for autism, which often emphasize early childhood interventions and behavioral therapies, STEPS targets the unique challenges adults with autism face as they strive for independence. This program stands out because it specifically aims to enhance daily living skills, social interactions, and self-reliance—areas that are crucial for improving quality of life but often overlooked in traditional approaches.

What evidence suggests that the STEPS program is effective for supporting emerging adults with autism?

Research has shown that the STEPS program, which participants in this trial may receive, is promising for helping teens and young adults with autism transition into adulthood. One study found that participants in the program at local community centers achieved positive results. They improved skills necessary for independence, such as securing jobs and continuing their education. The program is carefully designed to address the needs and challenges of people with autism. Overall, the STEPS program aims to help young adults with autism become more independent and successful in their communities. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for young individuals aged 16-25 with a confirmed diagnosis of Autism Spectrum Disorder (ASD) who are interested in participating in the STEPS program. They must also have a caregiver or parent available to complete assessments.

Inclusion Criteria

Willing to participate in STEPS

Have a caregiver/parent who can complete assessments

I am between 16 and 25 years old.

Exclusion Criteria

Presence of suicidal/homicidal intent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the STEPS program, a 14-session counseling targeting adult independence skills

14 weeks

14 sessions (in-person or virtual)

Follow-up

Participants are monitored for adult functional outcomes and vocational engagement

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Services as usual (SAU)
• STEPS

Trial Overview The trial is testing the STEPS support program, designed specifically for people with ASD, against standard services (SAU). It aims to see how well STEPS works when community agencies deliver it and what factors affect its success.

How Is the Trial Designed?

Group I: STEPS Experimental Treatment 1 Intervention

14 session counseling targeting adult independence skills

Group II: Control Experimental Treatment 1 Intervention

Services as usual

Who Is Running the Clinical Trial?

University of Alabama, Tuscaloosa

Lead Sponsor

Trials

49

Recruited

17,900+

Published Research Related to This Trial

The British Pain Society's care pathway emphasizes early patient education and self-management for persistent pain, aiming to improve initial pain management before a full diagnosis is completed.

Identifying patients at high risk for chronic disability early on can lead to more effective management and resource use, although implementing these recommendations presents significant challenges and requires further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial assessment and management of pain: a pathway for care developed by the British Pain Society. Price, C., Lee, J., Taylor, AM., et al.[2022]

Pain remains a significant public health issue in the U.S., despite efforts to improve pain assessment and management, indicating a need for more effective strategies.

South Nassau Communities Hospital has established a Pain Management Task Force to create a comprehensive pain management program, aiming to enhance patient care and meet accreditation standards for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain management: an organizational commitment. Ryan, M., Ambrosio, DA., Gebhard, C., et al.[2007]

Only one-third of authors involved in systematic reviews and randomized controlled trials for postoperative pain in children were aware of the PedIMMPACT core outcome set (COS), highlighting a significant gap in knowledge.

Barriers to using the COS included lack of awareness, implementation difficulties, and insufficient resources, suggesting a need for increased education and support to improve its adoption in pediatric pain research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Authors' lack of awareness and use of core outcome set on postoperative pain in children is hindering comparative effectiveness research. Boric, K., Boric, M., Dosenovic, S., et al.[2019]

A new pain management pathway for total joint replacement patients at Virginia Mason Medical Center led to the identification of gaps in patient education and communication regarding pain management.

The development of an evidence-based patient education tool, using quality improvement strategies, improved communication between patients and providers and enhanced pain assessment accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better pain management after total joint replacement surgery: a quality improvement approach. Gillaspie, M.[2019]

Training for social prescribers significantly improved their confidence in supporting patients with self-management of pain, particularly in areas like understanding pain and setting goals.

Despite the training's success, challenges remain in effectively communicating the nature of pain to patients, which is crucial for encouraging self-management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Power to the People, to the people': Training for social prescribers improves support of persistent pain. Corline, A., Cole, F., Trewern, L., et al.[2023]

The Stanford Chronic Pain Self-Management Programme (CPSMP) did not significantly reduce pain-related disability or healthcare costs in a study of 424 adults with chronic pain, indicating it may not be an effective treatment for this issue.

While there were small improvements in emotional distress and illness worry three months after the program, these changes were clinically insignificant, suggesting that the CPSMP may not provide meaningful benefits for individuals suffering from chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a lay-led, group-based self-management program for patients with chronic pain: a randomized controlled trial of the Danish version of the Chronic Pain Self-Management Programme. Mehlsen, M., Hegaard, L., Ørnbøl, E., et al.[2023]

The management of cancer pain is complicated and requires consideration of both patient and healthcare professional factors, highlighting the need for a comprehensive approach.

The article reviews various outcome measures used to assess improvements in cancer pain management, demonstrating the challenges and advantages of documenting changes in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes that provide evidence of change in cancer pain management. Dalton, JA.[2019]

A randomized controlled trial involving 215 veterans with chronic musculoskeletal pain tested a peer coach-delivered pain self-management program, but adherence to the program was low, with only 13% of patients attending the recommended number of meetings.

Both the peer support and control groups showed a decrease in total pain over 9 months, but there was no significant difference in pain reduction or other secondary outcomes between the two groups, suggesting that the peer support model may need to be revised for better effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer Support for Self-Management of Chronic Pain: the Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (ECLIPSE) Trial. Matthias, MS., Bair, MJ., Ofner, S., et al.[2021]

The Learning About My Pain study is a significant trial involving 294 participants that aims to compare the effectiveness of cognitive-behavioral and educational pain interventions against usual care for chronic pain management.

This study is one of the first funded by the Patient-Centered Outcomes Research Institute, emphasizing low-risk psychosocial treatments that may provide benefits without the undesirable side effects associated with medical pain treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Learning About My Pain study protocol: Reducing disparities with literacy-adapted psychosocial treatments for chronic pain, a comparative behavioral trial. Eyer, JC., Thorn, BE.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12396826/

Stepped Transition to Employment and Postsecondary ... In the Hybrid Type 1 trial, 24 adolescents and young adults with autism received STEPS in their communities at a local agency unaffiliated with ...

2. mdpi.com mdpi.com/2227-9067/12/9/1184

Effective Interventions in the Treatment of Self-Harming ... These interventions offered positive results, achieving significant improvements in reducing self-injurious behaviors and in the management of associated ...

3. jpain.org jpain.org/article/S1526-5900(24)00735-1/fulltext

The effects of autistic traits in adolescents on the efficacy ... Our study suggests that adolescents with greater autistic traits may benefit from existing pain rehabilitation programs at similar rates to their peers.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2324242623000281

Recent advancement in interventions for autism spectrum ... Physiotherapy is a tool for autistic children to maintain and improve their deficits and upcoming motor challenges. The investigated results of the studies ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5922249/

Development of a College Transition and Support Program ... The Stepped Transition in Education Program for Students with ASD (STEPS) is theoretically based and consumer-informed. Conceptually, the mechanisms of action ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11956318/

Health economic evaluation of Autism Adapted Safety Plans Autism Adapted Safety Plans (AASP) have been proposed to help prevent self-harm and suicidality among autistic adults.

7. uofmhealth.org uofmhealth.org/our-care/specialties-services/steps-autism-treatment-program

STEPS Autism Treatment Program The U-M Health STEPS Autism Treatment Program provides individualized treatment for children with autism in a small group setting and/or a combined speech ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0163725823002280

Retracing our steps: A review on autism research in ... There are no approved medications to treat the core symptoms of the disorder and behavioral interventions are typically used as first line treatment.