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Autism Spectrum Disorder (ASD)SOLVENCT06587594

Supportive Outcomes Through Listening, Validation, and Empowerment

A study testing Solution Focused Brief Therapy in people with Autism Spectrum Disorder (ASD), run by University of Texas at Austin at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This research aims to pilot an intervention that will provide practitioners and clinicians with evidenced-based behavioral health strategies for working with autistic adults. The findings will contribute to the needed, yet sparse research of evidence-based behavioral health interventions for this population. Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Autism Spectrum Disorder (ASD)
What is being tested?
Solution Focused Brief Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
14 Aug 2024to Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Autism diagnosis by a medical, mental health, or school professional
  • Between the ages of 18 and 30 years old
  • Proficient in English
  • Able to communicate verbally
  • Able to attend assessment and therapy sessions in person in a Center in Austin
  • Willing to complete two assessment sessions and 4 in-person therapy sessions

Who cannot join

  • screen positive for suicidal ideation
  • currently being treated for major mental health condition (medication or behavior intervention)
  • has a legal guardian designated by the court

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Texas, Texas Center for Disability Studies

    Austin, Texas, 78758

Other trials in United States

About this study

This research aims to pilot an intervention that will provide practitioners and clinicians with evidenced-based behavioral health strategies for working with autistic adults. The findings will contribute to the needed, yet sparse research of evidence-based behavioral health interventions for this population.

The guiding research aims for this study are:

Read more
  1. To implement a small-scale pilot study aimed at refining the Solution Focused Brief Therapy (SFBT) and protocol for use with autistic adults based on clinician expertise and lived experience.
  2. To test the feasibility and acceptability of the SFBT. Namely, how well the intervention is received by this population and if participants can attend and engage in all 4 sessions.
  3. To evaluate outcomes before and after the intervention and assess for any improvements through valid and reliable measurements of behavioral health outcomes.

This research aims to answer the following research questions:

  1. What is the retention rate of participants in the 4-weekly sessions of the SOLVE program?
  2. Do participants show progress in their self-identified goals after the intervention?
  3. What are the experiences and satisfaction rates of participants in participating in a four-session SFBT intervention?
  4. Do participants report higher scores in quality of life and lower depressive and anxiety scores between baseline and immediately post-intervention?

The five autistic participants will participate in four one-on-one weekly SFBT sessions conducted by licensed mental health professionals. The intervention is expected to take four to 5 weeks, allowing for cancelations and rescheduling as needed.

Read the detailed description

Step 1 of the first SFBT session: Introduction to SFBT Sessions and Agenda-setting The first SFBT session will include the introduction to SFBT sessions and agenda setting. The SFBT session and agenda description can be written down and given to the participants to read, take home, or be provided ahead of time in writing. The participants will be given time to ask questions.

Step 2 of the first SFBT session: Exploration of Strengths, Interests, and Support Systems After introducing the SFBT sessions, the clinician will ask about the participant's strengths, interests, and support systems. The goal of this phase should be to identify participant strengths, interests, and support systems. The participants will be reassured that they can take their time and that there are no right or wrong answers. The participants will be offered the option to use their preferred method of response and communication. The clinician will document the participant's chosen method of response and communication to maintain consistency and track preferences. The participant will be given the option to choose from multiple choice options if they are finding it challenging to answer the open-ended questions. The multiple-choice options will include an open-ended response.

Step 3 of the first SFBT session: Goal Exploration and Definition The clinician will invite the participant to develop a session topic and state their goal for the meeting. The goal will come from the participant and be co-constructed with the clinician. The goal will be described in concrete and behavioral terms. If the participant is finding it challenging to answer these open-ended, the clinician may offer multiple choice as examples or options but will be careful to not direct the participant.

Step 4 of the first SFBT session: Description of a Preferred Future The participant will describe in detail what their life will be like when they have reached their goal. The clinician will use concrete language defining each word. During the session the clinician will use a daily log to ask the participant to describe what they are doing differently at time points in the day.

Step 5 of the first SFBT session: Exploring Exceptions The clinician will help the participants identify exceptions to the problem or times when the problem has been less noticeable or is a little better for them.

Step 6 of the first SFBT session: Scaling Questions The clinicians ask the participants scaling questions to help the participants to anchor their problems or goals with descriptions on a scale and to use that rating to ask them what it will take for them to move forward to the next step. The participants will be offered to use a visual scale with pictures to represent the numbers.

Study Design. The study uses a one group pretest posttest design to assess and evaluate the feasibility and acceptability of Solution-Focused Brief Therapy (SFBT) in autistic adults. We will utilize both quantitative and qualitative measures to assess baseline and outcome. The study aims to recruit five autistic adults to participate in the pilot SFBT sessions in collaboration with community organization. Participants will undergo virtual screening (on the UT Zoom platform) and in-person pre-assessments before the first SFBT session. The assessments and four SFBT sessions will be conducted in-person. Each participant will undergo four in-person one-on-one SFBT sessions conducted by licensed mental health professionals. Post-assessments will be conducted in-person after the last SFBT session.

Data Analysis. Our main aims are to assess feasibility and acceptability. Feasibility will be determined by the number of eligible participants recruited to the study, the number of participants who completed all four sessions, and for those who didn't the number of sessions completed. Retention rates will be calculated by dividing the number that completed 4 sessions by 4.

Acceptability will be assessed using the open-ended questions in the interviews. To analyze open-ended questions, we will use a mixed approach combining inductive reasoning with predetermined codes related to the acceptability and satisfaction of the intervention (Tariq \& Woodman, 2013).

Secondary aims are to determine whether there are changes between pre and post-test that show promising trends.

All demographic variables (e.g. race/ethnicity, sex, sexual orientation, employment status, education level) will be summarized by standard descriptive statistics (means and standard deviations for continuous variables and frequencies for categorial variables). As the sample size is small, inferential analyses will be approached with caution. Assumptions for parametric analyses will be checked; if violated, nonparametric methods will be considered.

We will calculate summary statistics for total scores and scores on individual items on outcome measures. We will assess the normality of the differences between the pre and post test scores. We will analyze the pre and post scores using either a paired-sample t-test or the Wilcoxon signed-rank test depending on the distributional characteristics of the data. Effect sizes will be calculated.

Study measures. Social Responsiveness Scale Short Form (16 items): This scale is used with autistic individuals to identify and quantify the severity of social impairment. A study on a large sample of youth from four ASD databases demonstrated that the Social Responsiveness Scale Short Form (SRS-SF) has high reliability, with a Cronbach's alpha coefficient of 0.96, indicating strong internal consistency. The study suggested validity with the SRS-SF showing strong relationships with established measures of ASD severity, including the Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview-Revised (ADI-R), and Vineland Adaptive Behavior Scales. This suggests that the SRS-SF effectively captured core symptoms of ASD (Sturm et al., 2017).

Demographics and Household SES: A study-specific demographics questionnaire will be developed to capture background information. The demographic questions will take participants approximately 10 minutes to complete and will include sex and gender identity, SES, race/ethnicity, co-morbid ADHD and mental health diagnoses. Anxiety Scale for Adults-Autism The Anxiety Scale for Adults- Autism is a 20 item self-reported measure consisting of a General Anxiety Factor and three group factors: Social Anxiety, Anxious Arousal, and Uncertainty (Rodgers et al).

Depression Scale for Adults-Autism (ADAT-A): The ADAT-A is a self-reported 21 items measure designed with feedback from autistic adults, based on DSM-V and ICD-10 criteria for depression and adapted from the PHQ9. There are three subscales: Cognitive/Affective symptoms of depression according to DSM-V/ICD-10 criteria, Somatic symptoms of depression according to DSM-V/ICD-10 criteria and Autistic, autism-specific signs of depression (Cassidy et al).

PROMIS General Life Satisfaction- Short Form: The PROMIS General Life Satisfaction Short Form questionnaire is a 4 item self-reported measure assessing how much one agrees with each item in general rather than over a specified time period (PROMIS).

PROMIS Positive Affect Short Form: The PROMIS Positive Affect Short Form is a 15 item self-reported measure that assesses positive emotional experiences.

Open-ended questions: Before the SBFT sessions, we will ask participants questions regarding their current concerns, strengths and resources, expectations and goals, session feedback, and future outlook. After completing the four sessions, we will ask similar questions to see if there are any behavioral changes.

Post-intervention open ended questions:

  1. Current Concerns - Reflecting on the past sessions, have there been any changes in the challenges or difficulties you mentioned at the beginning?
  2. Strengths and Resources - Have you noticed any new strengths or resources that you did not recognize before starting the sessions?
  3. Expectations and Goals - Looking back, have your expectations or goals for the therapy been met? If so, how?
  4. Session Feedback - How would you describe your overall experience during the therapy sessions? What aspects did you find helpful or challenging? How do you feel about the number of SFBT sessions you received? What do you want to improve?
  5. Future Outlook - After completing the therapy sessions, how do you see yourself moving forward? What changes, if any, do you anticipate?
Being tested
Solution Focused Brief Therapy
Keywords
autism, mental health, solution focused brief therapy, autistic adults
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Solution Focused Brief TherapyBehavioural

    A behavioral health intervention designed to help autistic adults to make a positive change in their life using strength-based approach.

Study groups in NCT06587594
Study groupRoleWhat they receive
SFBT interventionExperimentalBehavioral: Solution-focused Brief Therapy (SFBT) A behavioral health intervention designed to help autistic adults to make a positive change in their life using strength-based approach.
Receives: Behavioral: Solution Focused Brief Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PROMIS General Life Satisfaction

    minimum 4 maximum 9, higher scores indicate higher general life satisfaction

    Measured: Change from baseline positive affect at one month

  2. PROMIS Positive Affect - Short Form

    minimum 15 maximum 75; higher scores indicate higher positive affect

    Measured: Change from baseline positive affect at one month

Secondary outcomes (2)
  1. Anxiety Scale for Adults - Autism

    minimum 20 maximum 80, higher scores indicate greater levels of anxiety

    Measured: Change from baseline depression at one month

  2. Depression Scale for Adults - Autism

    minimum 21 maximum 84, higher scores indicate greater levels of depression

    Measured: Change from baseline depression at one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start14 Aug 2024
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
One group pre and post-test design
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06587594
Sponsor's protocol ID
STUDY00006256
Acronym
SOLVE
Status last verified
Jul 2024
First submitted
4 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a small pilot study

Questions about this trial

What is this clinical trial studying?

A study testing Solution Focused Brief Therapy in people with Autism Spectrum Disorder (ASD), run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PROMIS General Life Satisfaction (time frame: Change from baseline positive affect at one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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