Autism Spectrum DisorderDRTPNCT03131635
Effectiveness of a Developmental Reciprocity Treatment Program in Autism
A study testing Developmental Reciprocity Treatment Program (DRT-P) in people with Autism Spectrum Disorder and Autism, run by Stanford University at 1 site in United States.
Trial summary
This is a research study examining the effectiveness of a Developmental Reciprocity Treatment Program (DRT-P) in treating social deficits in children with Autism Spectrum Disorders (ASD). Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- Developmental Reciprocity Treatment Program (DRT-P)
- 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
- 26 Jul 2017to 16 Jul 2020
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Autism Spectrum Disorder based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS-2), DSM-5, and expert clinical opinion;
- Males and females in good medical health between 2.0 and 5 years 11 months;
- Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;
- Stable treatment (e.g., applied behavior analysis), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation;
- Availability of at least one English-speaking parent who can consistently participate in parent training and research measures;
- Clinical Global Impression(CGI) Severity Social Interaction and Communication Integrated Subscale ≥4;
- Meet the cutoff for Autism on the ADOS-2.
Who cannot join
- Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
- A well-established genetic syndrome, such as Fragile X;
- Presence of active medical problem (e.g., unstable seizure disorder or heart disease);
- Child's primary language other than English;
- Previous adequate trial or training of a developmentally based intervention;
- Participants living more than 45 miles from Stanford University;
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- Children with more than 20 hours of in-home ABA;
- At least one room of the house must be available to be dedicated to treatment during session times;
- There must be no serious health and safety risks present in the home environment;
- The research team has the right to refuse to perform sessions in-home even if the criteria above are met.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University
Stanford, California, 94305-5719
About this study
This is a research study examining the effectiveness of a Developmental Reciprocity Treatment Program (DRT-P) in treating social deficits in children with Autism Spectrum Disorders (ASD). Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits.
Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement DRP with in-home, therapist-implemented treatment. To determine the effectiveness of the DRT-P, it will be compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid in providing better care for children with autism.
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- Developmental Reciprocity Treatment Program (DRT-P)
- Keywords
- Developmental
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Developmental Reciprocity Treatment Program (DRT-P)Behavioural
Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits.
| Study group | Role | What they receive |
|---|---|---|
| Developmental Reciprocity Treatment Program (DRT-P) | Experimental | Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits. Receives: Behavioral: Developmental Reciprocity Treatment Program (DRT-P) |
| Delayed Treatment Group (DTG) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
Measured: Baseline, 6, 12, and 24 weeks
Change from Baseline on the Brief Observation of Social Communication Change (BOSCC) at 24 weeks
Measured: Baseline and 24 weeks
Secondary outcomes (2)
Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 12, and 24 weeks
Measured: Baseline, 12, and 24 weeks
Change from Baseline on the Stanford Social Dimensions Scale (SSDS) Questionnaire.
Measured: Baseline, 12, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start26 Jul 2017
- Primary completion16 Jul 2020
- Study completion16 Jul 2020
Why it stopped: Terminated (halted prematurely) due to COVID-19.
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 Stanford UniversityThe 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Hardan, Stanford University
- Investigators
- Antonio Y. Hardan, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131635
- Sponsor's protocol ID
- IRB 40026
- Acronym
- DRTP
- Status last verified
- Sep 2022
- First submitted
- 24 Apr 2017
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Developmental Reciprocity Treatment Program in Autism
- ClinicalTrials.gov ID
- NCT03131635
- Acronym / sponsor ID
- DRTP / IRB 40026
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- Developmental
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated (halted prematurely) due to COVID-19.
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 27 Apr 2017 (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.
This is a research study examining the effectiveness of a Developmental Reciprocity Treatment Program (DRT-P) in treating social deficits in children with Autism Spectrum Disorders (ASD). Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits.
Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement DRP with in-home, therapist-implemented treatment. To determine the effectiveness of the DRT-P, it will be compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid in providing better care for children with autism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Developmental Reciprocity Treatment Program (DRT-P) | Experimental | Behavioral: Developmental Reciprocity Treatment Program (DRT-P)Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits. |
| Delayed Treatment Group (DTG) | No intervention | – |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Diagnosis of Autism Spectrum Disorder based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS-2), DSM-5, and expert clinical opinion;
- Males and females in good medical health between 2.0 and 5 years 11 months;
- Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;
- Stable treatment (e.g., applied behavior analysis), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation;
- Availability of at least one English-speaking parent who can consistently participate in parent training and research measures;
Key exclusion criteria (10 listed)
- Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
- A well-established genetic syndrome, such as Fragile X;
- Presence of active medical problem (e.g., unstable seizure disorder or heart disease);
- Child's primary language other than English;
- Previous adequate trial or training of a developmentally based intervention;
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 |
|---|---|---|
| Developmental Reciprocity Treatment Program (DRT-P)Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits. | Behavioural | Developmental Reciprocity Treatment Program (DRT-P) |
Primary outcome
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
Time frame: Baseline, 6, 12, and 24 weeks
Change from Baseline on the Brief Observation of Social Communication Change (BOSCC) at 24 weeks
Time frame: Baseline and 24 weeks
2 secondary outcomes
Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 12, and 24 weeks
Time frame: Baseline, 12, and 24 weeks
Change from Baseline on the Stanford Social Dimensions Scale (SSDS) Questionnaire.
Time frame: Baseline, 12, and 24 weeks
Results and safety
The study was stopped early (reason given: Terminated (halted prematurely) due to COVID-19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Antonio Y. Hardan, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Developmental Reciprocity Treatment Program (DRT-P) in people with Autism Spectrum Disorder and Autism, run by Stanford University 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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 15 Sep 2022. 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 was stopped early (reason given: Terminated (halted prematurely) due to COVID-19.). 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?
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks (time frame: Baseline, 6, 12, and 24 weeks). 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 15 Sep 2022.