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

Trial Summary

What is the purpose of this trial?

This study will inform understanding of how to support emerging adults with autism spectrum disorder (ASD). The investigators will use a theoretically informed and research-based transition support program developed for people with ASD and test how effective it is when delivered by community agencies. Results will provide information on the effectiveness of the program as well as on mechanisms of change and contextual factors that promote or impede implementation.

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 data supports the effectiveness of the STEPS Program for Autism treatment?

The STEPS Pain Self-Management Program may be effective for autism as it includes elements like patient education and self-management, which have shown benefits in managing chronic pain and improving patient outcomes in other conditions. ^{1 2 3 4 5}

How is the STEPS treatment for autism different from other treatments?

The STEPS Program for Autism is unique because it focuses on self-management of pain, which is not typically addressed in autism treatments. It emphasizes patient education and supported self-management, potentially involving peer support, to help individuals manage their symptoms more effectively. ^{3 6 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. England 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. [2019]

2. England 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. [2018]

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

Initial assessment and management of pain: a pathway for care developed by the British Pain Society. [2022]

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

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

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

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

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

Pain management: an organizational commitment. [2007]

7. England pubmed.ncbi.nlm.nih.gov

'Power to the People, to the people': Training for social prescribers improves support of persistent pain. [2023]

8. United States 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. [2021]

9. United States 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. [2023]