Tuberous Sclerosis ComplexNCT02687633
Early Behavioral Intervention to Improve Social Communication Function in Infants With Tuberous Sclerosis Complex
A study testing JASPER in people with Tuberous Sclerosis Complex, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The investigators are running an intervention study for young children with Tuberous Sclerosis Complex (TSC). The study will include free play-based behavioral intervention that may improve social and communication skills in children with TSC. Read more about this study
- Who is it for?
- Ages 12 to 36 months
- Conditions the study is for
- Tuberous Sclerosis Complex
- What is being tested?
- JASPER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Aug 2017
- 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 12 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A confirmed diagnosis of Tuberous Sclerosis Complex
Who cannot join
- A mental age less than 6 months. A plan for epilepsy surgery during the study participation period.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are running an intervention study for young children with Tuberous Sclerosis Complex (TSC). The study will include free play-based behavioral intervention that may improve social and communication skills in children with TSC. Eligible families will have a child in the age range of 12-36 months, with a diagnosis of TSC. A parent must also be available to attend the weekly intervention sessions at UCLA.
The intervention will focus on teaching caregivers skills to improve the social and communication outcomes of their children. The content of the intervention will be individually tailored to the child's developmental level. The intervention involves pre-assessments, an intervention period of daily 60 minute sessions for 10 days, followed by weekly 60 minute sessions for 10 weeks, and post-assessments. The classroom can have up to 3 parent-child dyad and the curriculum focuses on improving social-communication and play skills.
Read the detailed description
Most children with Tuberous Sclerosis Complex (TSC) suffer from neurodevelopmental disabilities, including intellectual disability (ID) and autism spectrum disorder (ASD). There is a tremendous need for early intervention for all infants with TSC, with a focus on improving non-verbal cognition and social communication skills. However, no studies have investigated whether early intervention can improve social communication skills in infants with TSC. As a result, families of infants with TSC struggle to receive adequate interventions targeting these areas of development.
The investigators propose to enroll 32 infants and toddlers with TSC to study an evidence-based behavioral intervention in infants with TSC, combining the efforts of investigators with expertise in autism intervention, infant development, and TSC. The proposed intervention study adapts a parent-mediated treatment called JASPER (Joint attention, symbolic play, engagement, regulation) that has successfully improved social communication outcomes in toddlers and young children with ASD.
JASPER intervention will last 3 months, and is split into two phases. Phase 1 occurs for the first 2 weeks of intervention, and consists of daily 1 hour intervention sessions (Monday through Friday) for 2 weeks. After Phase 1, Phase two begins, and consists of 60 minute sessions once a week for 10 weeks. Participants will receive behavioral assessments and EEG across 4 assessment time points during this study: At the start of participation in the study, two weeks into participation of the study, 3 months into participation of the study, and 6 months into participation in the study. The behavioral assessments administered throughout these time points will measure social communication skills, overall cognitive functioning, and non-verbal communication. EEG is sensitive to subtle changes in the brain and may be able to capture responses to treatment prior to clinical or behavioral change, and can inform researchers of the brain basis for the behavioral changes found with intervention. The EEG at each time point will be 30-45 minutes in length, and will require the participant to be awake, as they will watch several short videos on a tv screen while recording EEG data.
There are 2 randomized participation groups in this study, Treatment Group 1, and Treatment Group 2. Treatment group 1 will begin JASPER intervention immediately, and thus will complete the first 3 assessment time points while in intervention, and the 4th assessment time point 3 months after intervention ends. Treatment Group 2 will complete the 4 assessment time points while receiving services as usual in the community, and will begin intervention after the 4th assessment time point. Treatment group 1 will participate in this study for a total of 6 months, and treatment group 2 will participate in the study for a total of 9 months, since they will receive services in the community as usual for 6 months before beginning the 3 month intervention. Group assignment is randomized, and each participant has an equal chance of being assigned to either treatment group.
- Conditions
- Tuberous Sclerosis Complex
- Being tested
- JASPER
- Medical subject headings
- Tuberous Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JASPERBehavioural
Also called Joint Attention, Symbolic Play and Engagement Regulation
JASPER (Joint Attention, Symbolic Play, Engagement, and Regulation) is a treatment approach based on a combination of developmental and behavioral principles developed by Dr. Connie Kasari and Dr. Amanda Gulsrud at UCLA. It targets the foundations of social communication (joint attention, imitation, play) and uses naturalistic strategies to increase the rate and complexity of social communication.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The Treatment Group begins the JASPER intervention immediately upon enrollment in the study. Receives: Behavioral: JASPER |
| Delayed Treatment Group | Active comparator | The Delayed treatment group receives the same JASPER intervention as the Treatment Group, but after 6 months of receiving services in the community as usual. Receives: Behavioral: JASPER |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in Joint Engagement (shared engagement in a play routine) at 2 weeks into study participation, according to the parent caregiver interaction assessment.
Parent Caregiver Interaction assesses the amount of time the parent and child spend in engaged in the same play routine.
Measured: 2 weeks
change from baseline in Joint Engagement (shared engagement in a play routine) at 3 months into study participation, according to the parent caregiver interaction assessment.
Parent Caregiver Interaction assesses the amount of time the parent and child spend in engaged in the same play routine.
Measured: 3 months
change from baseline in Joint Engagement (shared engagement in a play routine) at 6 months into study participation, according to the parent caregiver interaction assessment.
Parent Caregiver Interaction assesses the amount of time the parent and child spend in engaged in the same play routine.
Measured: 6 months
Secondary outcomes (11)
Change from baseline in the amount of time spent in a Joint Attention (the coordination of attention between objects and people for the purpose of sharing) state at 2 weeks
ESCS (Early Social Communication Scales) Assessment.
Measured: 2 weeks
Change from baseline in the amount of time spent in a Joint Attention (the coordination of attention between objects and people for the purpose of sharing) state at 3 months
ESCS (Early Social Communication Scales) Assessment.
Measured: 3 months
Change from baseline in the amount of time spent in a Joint Attention (the coordination of attention between objects and people for the purpose of sharing) state at 6 months
ESCS (Early Social Communication Scales) Assessment.
Measured: 6 months
Change from baseline in Symbolic Play (types of play and level of play) at 2 weeks, according to the Structured Play Assessment (SPA)
The Structured Play Assessment measures the child's play level, based on distinct sets of toys that target specific developmental markers of play.
Measured: 2 weeks
Change from baseline in Symbolic Play (types of play and level of play) at 3 months, according to the Structured Play Assessment (SPA)
The Structured Play Assessment measures the child's play level, based on distinct sets of toys that target specific developmental markers of play.
Measured: 3 months
Change from baseline in Symbolic Play (types of play and level of play) at 6 months, according to the Structured Play Assessment (SPA)
The Structured Play Assessment measures the child's play level, based on distinct sets of toys that target specific developmental markers of play.
Measured: 6 months
Change from baseline at 3 months in developmental quotient, as determined by the Mullen Scales of Early Learning
Cognition will be determined by a Developmental Quotient on a traditional cognitive measure, the Mullen Scales of Early Learning
Measured: 3 months
Change from baseline at 6 months in developmental quotient, as determined by the Mullen Scales of Early Learning
Cognition will be determined by a Developmental Quotient on a traditional cognitive measure, the Mullen Scales of Early Learning
Measured: 6 months
Change from baseline at 2 weeks in the amount of Parent use of social communication support strategies
Parent use of social communication support strategies as taught by JASPER will be measured by a parent-child interaction assessment.
Measured: 2 weeks
Change from baseline at 3 months in the amount of Parent use of social communication support strategies
Parent use of social communication support strategies as taught by JASPER will be measured by a parent-child interaction assessment.
Measured: 3 months
Change from baseline at 6 months in the amount of Parent use of social communication support strategies
Parent use of social communication support strategies as taught by JASPER will be measured by a parent-child interaction assessment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberous Sclerosis ComplexStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Shafali Jeste, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687633
- Sponsor's protocol ID
- 15-000699
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2016
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Behavioral Intervention to Improve Social Communication Function in Infants With Tuberous Sclerosis Complex
- ClinicalTrials.gov ID
- NCT02687633
- Acronym / sponsor ID
- 15-000699
- Conditions
- Tuberous Sclerosis Complex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Boston Children's Hospital
- Study start
- Sep 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Feb 2016 (estimated)
- 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 investigators are running an intervention study for young children with Tuberous Sclerosis Complex (TSC). The study will include free play-based behavioral intervention that may improve social and communication skills in children with TSC. Eligible families will have a child in the age range of 12-36 months, with a diagnosis of TSC. A parent must also be available to attend the weekly intervention sessions at UCLA.
The intervention will focus on teaching caregivers skills to improve the social and communication outcomes of their children. The content of the intervention will be individually tailored to the child's developmental level. The intervention involves pre-assessments, an intervention period of daily 60 minute sessions for 10 days, followed by weekly 60 minute sessions for 10 weeks, and post-assessments. The classroom can have up to 3 parent-child dyad and the curriculum focuses on improving social-communication and play skills.
Detailed description
Most children with Tuberous Sclerosis Complex (TSC) suffer from neurodevelopmental disabilities, including intellectual disability (ID) and autism spectrum disorder (ASD). There is a tremendous need for early intervention for all infants with TSC, with a focus on improving non-verbal cognition and social communication skills. However, no studies have investigated whether early intervention can improve social communication skills in infants with TSC. As a result, families of infants with TSC struggle to receive adequate interventions targeting these areas of development.
The investigators propose to enroll 32 infants and toddlers with TSC to study an evidence-based behavioral intervention in infants with TSC, combining the efforts of investigators with expertise in autism intervention, infant development, and TSC. The proposed intervention study adapts a parent-mediated treatment called JASPER (Joint attention, symbolic play, engagement, regulation) that has successfully improved social communication outcomes in toddlers and young children with ASD.
JASPER intervention will last 3 months, and is split into two phases. Phase 1 occurs for the first 2 weeks of intervention, and consists of daily 1 hour intervention sessions (Monday through Friday) for 2 weeks. After Phase 1, Phase two begins, and consists of 60 minute sessions once a week for 10 weeks. Participants will receive behavioral assessments and EEG across 4 assessment time points during this study: At the start of participation in the study, two weeks into participation of the study, 3 months into participation of the study, and 6 months into participation in the study. The behavioral assessments administered throughout these time points will measure social communication skills, overall cognitive functioning, and non-verbal communication. EEG is sensitive to subtle changes in the brain and may be able to capture responses to treatment prior to clinical or behavioral change, and can inform researchers of the brain basis for the behavioral changes found with intervention. The EEG at each time point will be 30-45 minutes in length, and will require the participant to be awake, as they will watch several short videos on a tv screen while recording EEG data.
There are 2 randomized participation groups in this study, Treatment Group 1, and Treatment Group 2. Treatment group 1 will begin JASPER intervention immediately, and thus will complete the first 3 assessment time points while in intervention, and the 4th assessment time point 3 months after intervention ends. Treatment Group 2 will complete the 4 assessment time points while receiving services as usual in the community, and will begin intervention after the 4th assessment time point. Treatment group 1 will participate in this study for a total of 6 months, and treatment group 2 will participate in the study for a total of 9 months, since they will receive services in the community as usual for 6 months before beginning the 3 month intervention. Group assignment is randomized, and each participant has an equal chance of being assigned to either treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: JASPERThe Treatment Group begins the JASPER intervention immediately upon enrollment in the study. |
| Delayed Treatment Group | Active comparator | Behavioral: JASPERThe Delayed treatment group receives the same JASPER intervention as the Treatment Group, but after 6 months of receiving services in the community as usual. |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- A confirmed diagnosis of Tuberous Sclerosis Complex
Key exclusion criteria (1 listed)
- A mental age less than 6 months. A plan for epilepsy surgery during the study participation period.
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 |
|---|---|---|
| JASPERAlso: Joint Attention, Symbolic Play and Engagement RegulationJASPER (Joint Attention, Symbolic Play, Engagement, and Regulation) is a treatment approach based on a combination of developmental and behavioral principles developed by Dr. Connie Kasari and Dr. Amanda Gulsrud at UCLA. It targets the foundations of social communication (joint attention, imitation, play) and uses naturalistic strategies to increase the rate and complexity of social communication. | Behavioural | Delayed Treatment Group, Treatment Group |
Primary outcome
change from baseline in Joint Engagement (shared engagement in a play routine) at 2 weeks into study participation, according to the parent caregiver interaction assessment.
Time frame: 2 weeks
Parent Caregiver Interaction assesses the amount of time the parent and child spend in engaged in the same play routine.
change from baseline in Joint Engagement (shared engagement in a play routine) at 3 months into study participation, according to the parent caregiver interaction assessment.
Time frame: 3 months
Parent Caregiver Interaction assesses the amount of time the parent and child spend in engaged in the same play routine.
change from baseline in Joint Engagement (shared engagement in a play routine) at 6 months into study participation, according to the parent caregiver interaction assessment.
Time frame: 6 months
Parent Caregiver Interaction assesses the amount of time the parent and child spend in engaged in the same play routine.
11 secondary outcomes
Change from baseline in the amount of time spent in a Joint Attention (the coordination of attention between objects and people for the purpose of sharing) state at 2 weeks
Time frame: 2 weeks
Change from baseline in the amount of time spent in a Joint Attention (the coordination of attention between objects and people for the purpose of sharing) state at 3 months
Time frame: 3 months
Change from baseline in the amount of time spent in a Joint Attention (the coordination of attention between objects and people for the purpose of sharing) state at 6 months
Time frame: 6 months
Change from baseline in Symbolic Play (types of play and level of play) at 2 weeks, according to the Structured Play Assessment (SPA)
Time frame: 2 weeks
Change from baseline in Symbolic Play (types of play and level of play) at 3 months, according to the Structured Play Assessment (SPA)
Time frame: 3 months
Change from baseline in Symbolic Play (types of play and level of play) at 6 months, according to the Structured Play Assessment (SPA)
Time frame: 6 months
Change from baseline at 3 months in developmental quotient, as determined by the Mullen Scales of Early Learning
Time frame: 3 months
Change from baseline at 6 months in developmental quotient, as determined by the Mullen Scales of Early Learning
Time frame: 6 months
Change from baseline at 2 weeks in the amount of Parent use of social communication support strategies
Time frame: 2 weeks
Change from baseline at 3 months in the amount of Parent use of social communication support strategies
Time frame: 3 months
Change from baseline at 6 months in the amount of Parent use of social communication support strategies
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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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. This study is not recruiting at the moment.
Shafali Jeste, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JASPER in people with Tuberous Sclerosis Complex, run by University of California, Los Angeles 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change from baseline in Joint Engagement (shared engagement in a play routine) at 2 weeks into study participation, according to the parent caregiver interaction assessment. (time frame: 2 weeks). The study lists 3 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 23 Jul 2026.