Autism Spectrum DisorderNCT06859918
Randomized Clinical Trial of TUNE In 3.0: A Social/Emotional Program for Adults With Autism Spectrum Disorder
A study testing TUNE In: Training to Understand and Navigate Emotions and Interactions in people with Autism Spectrum Disorder and Autism, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to test a novel, cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder, Autism, Autistic Disorder
- What is being tested?
- TUNE In: Training to Understand and Navigate Emotions and Interactions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Meet ASD diagnostic criteria supported by an outside diagnostic evaluation and/or by the clinical and developmental information gathered from a phone screen
- Be willing to complete screening surveys (outcome measures)
- Social Responsiveness Score, Second Edition, self-report SRS survey score of greater than or equal to 60
Who cannot join
- Severe self-injurious or aggressive behaviors; or with suicidal or homicidal ideation or behaviors (e.g. suicide attempt) within the last 6 months
- Major mood episode (major depressive episode, manic episode), psychotic symptoms, or a psychiatric hospitalization within the last 6 months
- A history of intellectual disability or low Shipley-2 score
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brodkin Lab contact
United States1 site, 1 recruiting
- Recruiting
Brodkin Lab: Perelman School of Medicine, Department of Psychiatry, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Giulietta Flaherty, flahertyg@pennmedicine.upenn.edu
About this study
Official title: ASPE Subproject - Training to Understand and Navigate Emotions and Interactions (TUNE In)
The purpose of this study is to test a novel, cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder.
The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings.
The Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.
- Conditions
- Autism Spectrum Disorder, Autism, Autistic Disorder, Asperger Syndrome
- Being tested
- TUNE In: Training to Understand and Navigate Emotions and Interactions
- Keywords
- Social Skills, Emotion Regulation, Autistic Adults
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome, Social Skills, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUNE In: Training to Understand and Navigate Emotions and InteractionsBehavioural
A cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. TUNE In includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, and social skills.
| Study group | Role | What they receive |
|---|---|---|
| Delay Start Group | Other | The Delay Start Group receives the intervention 1-6 months after the Immediate Start Group. Receives: Behavioral: TUNE In: Training to Understand and Navigate Emotions and Interactions |
| Immediate Start Group | Experimental | The Immediate Start Group receives the intervention as soon as the trial starts. Receives: Behavioral: TUNE In: Training to Understand and Navigate Emotions and Interactions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Responsiveness Scale (SRS) - Self Report
A 65 item self-report measure that identifies the presence and severity of social impairment within the autism spectrum.
Measured: From enrollment to 6 months follow up
Secondary outcomes (11)
Social Responsiveness Scale (SRS) - Informant Report
A 65 item measure that identifies the presence and severity of social impairment within the autism spectrum. This is completed by a friend/family member of the participant based on their perceptions of the participants' behavior.
Measured: From enrollment to 6 months follow up
CAT-Q - Camouflaging Autistic Traits Questionnaire
A 25 item measure that assesses the extent to which individuals with autism mask or camouflage their autistic traits in social situations.
Measured: From enrollment to 6 months follow up
Five Facet Mindfulness Questionnaire
A 39-item measure that assesses five aspects of mindfulness: observing, describing, acting with awareness, non-judging, and non-reactivity.
Measured: From enrollment to 6 months follow up
Generalized Anxiety Disorder-7
A 7-item measure that assesses the severity of generalized anxiety disorder symptoms.
Measured: From enrollment to 6 months follow up
Glasgow Sensory Questionnaire
A 42-item measure that assesses sensory sensitivities and differences across multiple sensory modalities.
Measured: From enrollment to 6 months follow up
Insomnia Severity Inde
A 7-item measure that assesses the severity of insomnia symptoms and their impact on daily functioning.
Measured: From enrollment to 6 months follow up
Inventory of Socially Supportive Behaviors
A 40-item measure that assesses the frequency and types of social support individuals receive.
Measured: From enrollment to 6 months follow up
Social Network Index
A 12-item measure that assesses the size, diversity, and level of engagement in an individual's social network.
Measured: From enrollment to 6 months follow up
Scales of Psychological Wellbeing
A 42 item measure that assesses six dimensions of psychological well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance.
Measured: From enrollment to 6 months follow up
Attunement Quiz
A 25 item measure that assess attunement: one's ability to perceive, interpret, and respond to one's internal and external environment, in particular the social environment.
Measured: From enrollment to 6 months follow up
Liebowitz Social Anxiety Scale - Self-Report
A 24-item measure that assesses the severity of social anxiety symptoms related to fear and avoidance in social and performance situations.
Measured: From enrollment to 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start24 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study involves two groups of participants, who both receive the intervention at different times. The "Immediate Start Group" will get the intervention at the beginning of the trial, while the "Delay Start Group" will receive the intervention 1-6 months after the Immediate Start Group. Participants will be randomly assigned to groups.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Brodkin, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859918
- Sponsor's protocol ID
- TUNE In 3.0
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available through NIH NDAR registry
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASPE Subproject - Training to Understand and Navigate Emotions and Interactions (TUNE In)
- ClinicalTrials.gov ID
- NCT06859918
- Acronym / sponsor ID
- TUNE In 3.0
- Conditions
- Autism Spectrum Disorder, Autism, Autistic Disorder, Asperger Syndrome
- Keywords
- Social Skills, Emotion Regulation, Autistic Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test a novel, cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder.
The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings.
The Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study involves two groups of participants, who both receive the intervention at different times. The "Immediate Start Group" will get the intervention at the beginning of the trial, while the "Delay Start Group" will receive the intervention 1-6 months after the Immediate Start Group. Participants will be randomly assigned to groups.
| Arm | Type | Receives |
|---|---|---|
| Delay Start Group | Other | Behavioral: TUNE In: Training to Understand and Navigate Emotions and InteractionsThe Delay Start Group receives the intervention 1-6 months after the Immediate Start Group. |
| Immediate Start Group | Experimental | Behavioral: TUNE In: Training to Understand and Navigate Emotions and InteractionsThe Immediate Start Group receives the intervention as soon as the trial starts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Meet ASD diagnostic criteria supported by an outside diagnostic evaluation and/or by the clinical and developmental information gathered from a phone screen
- Be willing to complete screening surveys (outcome measures)
- Social Responsiveness Score, Second Edition, self-report SRS survey score of greater than or equal to 60
Key exclusion criteria (3 listed)
- Severe self-injurious or aggressive behaviors; or with suicidal or homicidal ideation or behaviors (e.g. suicide attempt) within the last 6 months
- Major mood episode (major depressive episode, manic episode), psychotic symptoms, or a psychiatric hospitalization within the last 6 months
- A history of intellectual disability or low Shipley-2 score
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TUNE In: Training to Understand and Navigate Emotions and InteractionsA cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. TUNE In includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, and social skills. | Behavioural | Delay Start Group, Immediate Start Group |
Primary outcome
Social Responsiveness Scale (SRS) - Self Report
Time frame: From enrollment to 6 months follow up
A 65 item self-report measure that identifies the presence and severity of social impairment within the autism spectrum.
11 secondary outcomes
Social Responsiveness Scale (SRS) - Informant Report
Time frame: From enrollment to 6 months follow up
CAT-Q - Camouflaging Autistic Traits Questionnaire
Time frame: From enrollment to 6 months follow up
Five Facet Mindfulness Questionnaire
Time frame: From enrollment to 6 months follow up
Generalized Anxiety Disorder-7
Time frame: From enrollment to 6 months follow up
Glasgow Sensory Questionnaire
Time frame: From enrollment to 6 months follow up
Insomnia Severity Inde
Time frame: From enrollment to 6 months follow up
Inventory of Socially Supportive Behaviors
Time frame: From enrollment to 6 months follow up
Social Network Index
Time frame: From enrollment to 6 months follow up
Scales of Psychological Wellbeing
Time frame: From enrollment to 6 months follow up
Attunement Quiz
Time frame: From enrollment to 6 months follow up
Liebowitz Social Anxiety Scale - Self-Report
Time frame: From enrollment to 6 months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Yes. Data will be available through NIH NDAR registry
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brodkin Lab contact
Edward Brodkin, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TUNE In: Training to Understand and Navigate Emotions and Interactions in people with Autism Spectrum Disorder and Autism, run by University of Pennsylvania 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 4 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward Brodkin, M.D (215-746-4100, ebrodkin@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Responsiveness Scale (SRS) - Self Report (time frame: From enrollment to 6 months follow up). 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 13 Mar 2026.