TSCTRAINNCT04698538
TSC Remote Assessment and Intervention
A study testing JASPER in people with TSC, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The investigators propose a study to adapt an evidence-based caregiver training program to improve access in order to better serve the TSC community. The proposed adapted caregiver training program is based on a targeted behavioral intervention called JASPER (Joint attention, symbolic play, engagement, and regulation)… Read more about this study
- Who is it for?
- Ages 12 to 36 months
- Conditions the study is for
- TSC
- 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
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2020to 28 Oct 2024
- 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
- Confirmed clinical diagnosis of TSC
- Chronological age of 12--36 months
- English as primary language at home
- Have a parent available for weekly remote video conferencing
- Scores of 22.5 Gross Motor and 25.14 Fine Motor on the Ages and Stages Questionnaire (ASQ).
Who cannot join
- Plan for epilepsy surgery during study period
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose a study to adapt an evidence-based caregiver training program to improve access in order to better serve the TSC community. The proposed adapted caregiver training program is based on a targeted behavioral intervention called JASPER (Joint attention, symbolic play, engagement, and regulation) that has successfully improved outcomes in children with ASD. Importantly, JASPER specifically targets two key developmental domains known to be critical for young children with TSC, social communication and play. Recent work with JASPER in children with TSC shows promise, but still requires a commitment to regular in-person sessions. The investigators hope to test an adapted version of the caregiver training version of JASPER, where the entire training is provided remotely through weekly teleconferences and video feedback. The investigators goal is to determine if remote caregiver training can improve social engagement and communication between caregivers and their child with TSC.
The investigators hope that by adapting the caregiver training version of JASPER to be delivered through telehealth methods, the investigators can help more families gain access to high quality training. There is a tremendous need for high quality early intervention, and remote caregiver training can give families the skills they need to make impactful and lasting improvements for their child with TSC.
The investigators will recruit 66 children, 22 per year whom have been clinically diagnosed with TSC, are 12-36 months of age, English as primary language at home, and have one parent available for weekly remote video conferencing. Participants that meet criteria will be asked to complete assessments from their home (kits will be mailed to them), which will take several sessions (approximately 2.5 hours). During these assessment sessions via Zoom, participants will be shown how to do BOSA, SPACE and CCX assessments. A Vineland and Ages and Stages Questionnaire will also be done during these sessions, but it's just questionnaires. The SPACE and CCX are particulary important because the participants will have to record themselves throughout the study doing these assessments. A brief introduction to JASPER will also be given during this period of assessments. Randomization will occur after assessments are complete. Participants randomized to intervention will need to meet with the research staff for 12 weeks via Zoom to discuss their recorded sessions. Each participant in the intervention group is expected to submit (via UCLA Box) a 30-40 minute video doing JASPER with their child. These videos will be discussed during the Zoom calls. The group not randomized to intervention, will continue to care for their child as usual for those 12 weeks. They will not need to record or meet via Zoom with the research staff. At the end of the 12 weeks, all participants will record themselves doing the two assessments that were taught at UCLA. They will do and record these assessments again 12 weeks after that in the 3-month follow up. The total study is for 6 months.
Read the detailed description
Sixty-six participants (22 per year) will be recruited, consented, and complete remote assessments. The assessments consist of the BOSA, Vineland, the Short Play and Communication Evaluation (SPACE), and Caregiver Child Interaction (CCX). The SPACE and CCX will be done throughout the study. The JASPER introduction and information consist of a self-guided module introducing caregivers to the developmental concepts of joint engagement, social communication, and play. They will receive online handouts and strategies as well. A demographic form and Caregiver Expectancies Belief form wlll also be completed at this point. After assessments and this JASPER introduction meeting, participants will be randomized to receive self guided JASPER intervention materials with remote JASPER coaching intervention or self guided materials only. Both conditions, JASPER materials plus coaching or JASPER materials only, will last for 12 weeks. The caregivers randomized to intervention, will do JASPER 30-40 minutes per day (Monday through Friday). They will record one of these days and share it with the UCLA research staff via a secure network, such as UCLA box. Each week one of the UCLA research staff will meet via Zoom or Skype to discuss the video. During these 12 weeks, parents will fill out Caregiver Involvement Scale, and Caregiver Diary forms weekly. After the 12 weeks, the participants will all do a remote SPACE and CCX. The Vineland and Ages and Stages Questionnaire (Gross and Fine Motors sections only), which was done during the screening will also be done at this time point over the phone or through Zoom. Participants will have a follow up SPACE and CCX, 3 months after entry (24 weeks of study) as well. The Vineland and Ages and Stages Questionnaire (Gross and Fine Motors sections only) will also be done at this time point over the phone or through Zoom as well.The Caregiver Expectancies/Belief forms will also be completed at week 1, after the 12 weeks of intervention (exit), and at the 3 month follow up.
- Conditions
- TSC
- Being tested
- JASPER
- Keywords
- TSC, tuberous sclerosis complex
- 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
JASPER is a naturalistic, developmental, behavioral intervention (NDBI) that focuses on developing social communication and language skills in the context of a play based intervention.
| Study group | Role | What they receive |
|---|---|---|
| Educational Materials | No intervention | Caregivers in this arm will receive intervention material, but no coaching. The material consists of a self-guided module introducing caregivers to the developmental concepts of joint engagement, social communication, and play. |
| JASPER intervention | Experimental | The caregivers randomized to intervention, will meet twice a week with UCLA staff to do session planning one day and JASPER remote, live coaching another day. The caregivers are expected to meet with the UCLA team twice a week. Receives: Behavioral: JASPER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Caregiver-Child Interaction (CCX)-joint engagement
The child is jointly engaged with the caregiver in recorded play interactions. A change from entry (1st month of study) to exit (month 3 of study) will be assessed and exit (3 month of study) to follow up (month 6) as well as entry to follow up (month 6) will be assessed.
Measured: entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)
Change in Short Play and Communication Evaluation (SPACE)- joint engagement
The child is jointly engaged with the caregiver in recorded play interactions. A change from entry (1st month of study) to exit (month 3 of study) will be assessed and exit (3 month of study) to follow up (month 6) as well as entry to follow up (month 6) will be assessed.
Measured: entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)
Secondary outcomes (2)
Short Play and Communication Evaluation (SPACE)- Joint attention
The child is initiating social communication with the caregiver in recorded assessments.
Measured: entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)
Short Play and Communication Evaluation (SPACE)- Play
The child is initiating play acts that are characterized by developmental level in recorded assessments.
Measured: entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start31 Oct 2020
- Primary completion31 Aug 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TSCStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Connie Kasari, Ph.D., University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698538
- Sponsor's protocol ID
- 20-000010
- Acronym
- TRAIN
- Status last verified
- Oct 2024
- First submitted
- 2 Nov 2020
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TSC Remote Assessment and Intervention
- ClinicalTrials.gov ID
- NCT04698538
- Acronym / sponsor ID
- TRAIN / 20-000010
- Conditions
- TSC
- Keywords
- TSC, tuberous sclerosis complex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 31 Oct 2020 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 7 Jan 2021 (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 investigators propose a study to adapt an evidence-based caregiver training program to improve access in order to better serve the TSC community. The proposed adapted caregiver training program is based on a targeted behavioral intervention called JASPER (Joint attention, symbolic play, engagement, and regulation) that has successfully improved outcomes in children with ASD. Importantly, JASPER specifically targets two key developmental domains known to be critical for young children with TSC, social communication and play. Recent work with JASPER in children with TSC shows promise, but still requires a commitment to regular in-person sessions. The investigators hope to test an adapted version of the caregiver training version of JASPER, where the entire training is provided remotely through weekly teleconferences and video feedback. The investigators goal is to determine if remote caregiver training can improve social engagement and communication between caregivers and their child with TSC.
The investigators hope that by adapting the caregiver training version of JASPER to be delivered through telehealth methods, the investigators can help more families gain access to high quality training. There is a tremendous need for high quality early intervention, and remote caregiver training can give families the skills they need to make impactful and lasting improvements for their child with TSC.
The investigators will recruit 66 children, 22 per year whom have been clinically diagnosed with TSC, are 12-36 months of age, English as primary language at home, and have one parent available for weekly remote video conferencing. Participants that meet criteria will be asked to complete assessments from their home (kits will be mailed to them), which will take several sessions (approximately 2.5 hours). During these assessment sessions via Zoom, participants will be shown how to do BOSA, SPACE and CCX assessments. A Vineland and Ages and Stages Questionnaire will also be done during these sessions, but it's just questionnaires. The SPACE and CCX are particulary important because the participants will have to record themselves throughout the study doing these assessments. A brief introduction to JASPER will also be given during this period of assessments. Randomization will occur after assessments are complete. Participants randomized to intervention will need to meet with the research staff for 12 weeks via Zoom to discuss their recorded sessions. Each participant in the intervention group is expected to submit (via UCLA Box) a 30-40 minute video doing JASPER with their child. These videos will be discussed during the Zoom calls. The group not randomized to intervention, will continue to care for their child as usual for those 12 weeks. They will not need to record or meet via Zoom with the research staff. At the end of the 12 weeks, all participants will record themselves doing the two assessments that were taught at UCLA. They will do and record these assessments again 12 weeks after that in the 3-month follow up. The total study is for 6 months.
Detailed description
Sixty-six participants (22 per year) will be recruited, consented, and complete remote assessments. The assessments consist of the BOSA, Vineland, the Short Play and Communication Evaluation (SPACE), and Caregiver Child Interaction (CCX). The SPACE and CCX will be done throughout the study. The JASPER introduction and information consist of a self-guided module introducing caregivers to the developmental concepts of joint engagement, social communication, and play. They will receive online handouts and strategies as well. A demographic form and Caregiver Expectancies Belief form wlll also be completed at this point. After assessments and this JASPER introduction meeting, participants will be randomized to receive self guided JASPER intervention materials with remote JASPER coaching intervention or self guided materials only. Both conditions, JASPER materials plus coaching or JASPER materials only, will last for 12 weeks. The caregivers randomized to intervention, will do JASPER 30-40 minutes per day (Monday through Friday). They will record one of these days and share it with the UCLA research staff via a secure network, such as UCLA box. Each week one of the UCLA research staff will meet via Zoom or Skype to discuss the video. During these 12 weeks, parents will fill out Caregiver Involvement Scale, and Caregiver Diary forms weekly. After the 12 weeks, the participants will all do a remote SPACE and CCX. The Vineland and Ages and Stages Questionnaire (Gross and Fine Motors sections only), which was done during the screening will also be done at this time point over the phone or through Zoom. Participants will have a follow up SPACE and CCX, 3 months after entry (24 weeks of study) as well. The Vineland and Ages and Stages Questionnaire (Gross and Fine Motors sections only) will also be done at this time point over the phone or through Zoom as well.The Caregiver Expectancies/Belief forms will also be completed at week 1, after the 12 weeks of intervention (exit), and at the 3 month follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Materials | No intervention | –Caregivers in this arm will receive intervention material, but no coaching. The material consists of a self-guided module introducing caregivers to the developmental concepts of joint engagement, social communication, and play. |
| JASPER intervention | Experimental | Behavioral: JASPERThe caregivers randomized to intervention, will meet twice a week with UCLA staff to do session planning one day and JASPER remote, live coaching another day. The caregivers are expected to meet with the UCLA team twice a week. |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Confirmed clinical diagnosis of TSC
- Chronological age of 12--36 months
- English as primary language at home
- Have a parent available for weekly remote video conferencing
- Scores of 22.5 Gross Motor and 25.14 Fine Motor on the Ages and Stages Questionnaire (ASQ).
Key exclusion criteria (1 listed)
- Plan for epilepsy surgery during study 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 |
|---|---|---|
| JASPERJASPER is a naturalistic, developmental, behavioral intervention (NDBI) that focuses on developing social communication and language skills in the context of a play based intervention. | Behavioural | JASPER intervention |
Primary outcome
Change in Caregiver-Child Interaction (CCX)-joint engagement
Time frame: entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)
The child is jointly engaged with the caregiver in recorded play interactions. A change from entry (1st month of study) to exit (month 3 of study) will be assessed and exit (3 month of study) to follow up (month 6) as well as entry to follow up (month 6) will be assessed.
Change in Short Play and Communication Evaluation (SPACE)- joint engagement
Time frame: entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)
The child is jointly engaged with the caregiver in recorded play interactions. A change from entry (1st month of study) to exit (month 3 of study) will be assessed and exit (3 month of study) to follow up (month 6) as well as entry to follow up (month 6) will be assessed.
2 secondary outcomes
Short Play and Communication Evaluation (SPACE)- Joint attention
Time frame: entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)
Short Play and Communication Evaluation (SPACE)- Play
Time frame: entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)
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 30 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 TSC, 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 5 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 30 Oct 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?
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 in Caregiver-Child Interaction (CCX)-joint engagement (time frame: entry (1st month of study), exit (month 3 of the study), follow up (month 6 of the study)). 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 30 Oct 2024.