Autism Spectrum DisorderNCT03889821
Mindfulness Training and Parent-coaching Interventions for Autism Spectrum Disorder
A study testing Parent-implemented Early Start Denver Model and Mindfulness Based Stress Reduction in people with Autism Spectrum Disorder and Parents, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Caregivers of children with autism spectrum disorder (ASD) report higher levels of depression and distress than caregivers of typically developing children as well as children with other developmental disabilities. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Autism Spectrum Disorder, Parents, Stress
- What is being tested?
- Parent-implemented Early Start Denver Model and Mindfulness Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2015to 23 Mar 2018
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Child has diagnosis of autism spectrum disorder
- Child at least 12 months of age but less than 36 months at time of consent
- Parent speaks and reads fluent English
Who cannot join
- Severe child sensorimotor impairment that would impact participation in treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
Official title: Does Mindfulness Training Enhance Early Evidence-based Parent-coaching Interventions for Autism Spectrum Disorder?: A Randomized Controlled Trial
Caregivers of children with autism spectrum disorder (ASD) report higher levels of depression and distress than caregivers of typically developing children as well as children with other developmental disabilities. The proposed work tests a novel treatment paradigm that blends Mindfulness Based Stress Reduction (MBSR) with an empirically supported and manualized parent training program (Parent-Implemented Early Start Denver Model [P-ESDM]). We hypothesize that directly treating parental distress, while simultaneously providing evidence-based parent training, may greatly enhance child-focused intervention and provide benefits that resonate across the family.
- Conditions
- Autism Spectrum Disorder, Parents, Stress
- Being tested
- Parent-implemented Early Start Denver Model, Mindfulness Based Stress Reduction
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-implemented Early Start Denver ModelBehavioural
The Parent-implemented Early Start Denver Model (P-ESDM; Rogers et al., 2012) consists of 12 consecutive sessions, each session approximately 1 hour long, that promote parental ability to support and interact with their young children with autism spectrum disorder (ASD). Intervention sessions are conducted in the clinic setting by therapists trained to fidelity by ESDM-certified parent trainers. The manualized intervention has a detailed parent-training curriculum, a specific coaching intervention method, and a therapist fidelity measure. Therapists introduce skills through descriptions, interaction, modeling, coaching, and feedback.
Mindfulness Based Stress ReductionBehavioural
The Mindfulness Based Stress Reduction (MBSR) protocol is derived from the work by Dykens et al. (2014), which is based on the stress reduction and relaxation program (Kabat-Zinn, 1982, 1990). In this study, it is offered as 6 weekly sessions that run concurrent with the P-ESDM intervention. Participants work one-on-one with a therapist for instruction and practice in mindfulness skills as well as discussions of stress, coping, and homework assignments.
| Study group | Role | What they receive |
|---|---|---|
| Child-focused Treatment | Active comparator | Participants in this group participate in 12 sessions of the Parent-implemented Early Start Denver Model (P-ESDM). Receives: Behavioral: Parent-implemented Early Start Denver Model |
| Child- and Parent-focused Treatment | Experimental | Participants in this group participate in 12 sessions of the Parent-implemented Early Start Denver Model (P-ESDM). Parents also participate in 6 separate, individual sessions of Mindfulness Based Stress Reduction (MBSR). Receives: Behavioral: Parent-implemented Early Start Denver Model; Behavioral: Mindfulness Based Stress Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parental stress
The Parenting Stress Index - Short Form, Third Edition (PSI-SF; Abidin, 1995), is a 36-item measure that yields three subscale scores (Parent Child Dysfunctional Interaction, Parenting Distress, Difficult Child) used in present analyses. Each item is rated as by parents as: SA (strongly agree), A (agree), NS (not sure), D (disagree), SD (strongly disagree). Scores are converted to percentile ranks, with higher scores indicating higher levels of stress. Percentile ranks of 15-80 considered typical, and ranks of 81 and above are considered high.
Measured: Baseline to end of study (Every 6 weeks for 9 months)
Change in parental depression
Parents completed the Beck Depression Inventory (BDI; Beck et al., 1984). This instrument consists of 21 items, with higher scores reflecting higher levels of symptomatology.
Measured: Baseline to end of study (Every 6 weeks for 9 months)
Change in parental anxiety
Parents completed the Beck Anxiety Inventory (BAI; Beck et al., 1988). This instrument consists of 21 items, with higher scores reflecting higher levels of symptomatology.
Measured: Baseline to end of study (Every 6 weeks for 9 months)
Change in parental mindfulness
. Parents completed the Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006). The FFMQ consists of 44 items that yield five subscales: Observing, Describing, Acting with Awareness, Nonreactivity, and Nonjudging. Higher scores indicate more mindfulness.
Measured: Baseline to end of study (Every 6 weeks for 9 months)
Change in parent relationship quality
The Dyadic Adjustment Scale (DAS; Spanier, 1989) is a 32-item measure that assesses relationship satisfaction. It includes four subscales scored using a mix of Likert and dichotomous responses. Higher scores indicate higher relationship satisfaction.
Measured: Baseline to end of study (Every 6 weeks for 9 months)
Change in parental life satisfaction
Parents completed the Satisfaction with Life Scale (SLS; Diener et al., 1984). The SLS is a 5-item measure of subjective wellbeing, with each item scored along a 7-point Likert scale (higher scores indicate more satisfaction).
Measured: Baseline to end of study (Every 6 weeks for 9 months)
Change in parental sleep quality
Parents completed the Insomnia Severity Index (ISI; Bastien et al., 2011). The ISI consists of seven items scored from 0-4, with higher scores reflecting more sleep-related impairment.
Measured: Baseline to end of study (Every 6 weeks for 9 months)
Secondary outcomes (5)
Change in child autism symptom severity
The Autism Diagnostic Observation Schedule - Second Edition (ADOS-2; Lord et al., 2012) is a standardized clinical observation system for use with people with developmental ages of 12 months and older. Each child completes one module based upon age and language level. This module yields a Calibrated Severity Scores (CSS; range: 1-10). Higher scores reflect higher levels of autism symptoms.
Measured: Baseline, end of treatment (12 weeks), end of study (9 months)
Change in child cognitive functioning
The Mullen Scales of Early Learning (MSEL; Mullen, 1995) is a standardized developmental test for children up to age five years.57 It provides scores in four domains (Visual Reception, Fine Motor, Receptive Language, Expressive Language; M=50, SD=10) and yields an overall ability index termed the Early Learning Composite (ELC; M=100, SD=15). Higher scores reflect higher levels of abilities relative to same-aged peers.
Measured: Baseline, end of treatment (12 weeks), end of study (9 months)
Change in child adaptive behavior
The Vineland Adaptive Behavior Scales - Second Edition (VABS-II; Sparrow et al., 1985), Interview Form is a semistructured interview. It yields four domain standard scores: Communication, Daily Living Skills, Socialization, and Motor Skills (M = 100, SD = 15) as well as an overall Adaptive Behavior Composite (M = 100, SD = 15). High scores reflect better developed adaptive behavior skills.
Measured: Baseline, end of treatment (12 weeks), end of study (9 months)
Change in child problem behaviors
The Achenbach Child Behavior Checklist (CBCL; Achenbach, 2001) yields Internalizing, Externalizing, and Total Problem composite scores. Scores are reported as T scores, with T scores above 65 reflecting clinical significance.
Measured: Baseline, end of treatment (12 weeks), end of study (9 months)
Change in child communication behaviors
The MacArthur CDI Words and Gestures (Fenson et al., 2006) provides a count of parent-reported phrases understood, vocabulary comprehension and production, and actions and gestures. Higher scores indicate more reported language skills.
Measured: Baseline, end of treatment (12 weeks), end of study (9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start11 Mar 2015
- Primary completion23 Mar 2018
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Weitlauf, Vanderbilt University Medical Center
- Investigators
- Amy S Weitlauf, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889821
- Sponsor's protocol ID
- MBSR and P-ESDM
- Other IDs
- R40MC30769
- Status last verified
- Mar 2019
- First submitted
- 20 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing procedures will adhere to guidelines established by the NIH sponsored National Database for Autism Research (NDAR). NDAR is a scalable informatics platform for ASD relevant data. NDAR was developed to share data and facilitate collaboration across the ASD field. We will participate in this system for sharing data in hopes that such sharing will accelerate research progress by allowing re-analysis of data, as well as re-aggregation, integration, and rigorous comparison with other data, tools, and methods. We will submit both descriptive and experimental data (http://ndar.nih.gov/).
Publications
Abidin, R. (1995). Parenting Stress Index, 3rd Edition. Lutz, FL: Psychological Assessment Resources.
Achenbach, T. M. (2001). Achenbach Child Behavior Checklist. Burlington, VT: ASEBA.
Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
PubMed 16443717Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PubMed 3204199Beck AT, Steer RA., Brown GK . Manual for the Beck Depression Inventory-II. 1996. San Antonio: Psychological Corporation.
Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
PubMed 11438246Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
PubMed 16367493Dykens EM, Fisher MH, Taylor JL, Lambert W, Miodrag N. Reducing distress in mothers of children with autism and other disabilities: a randomized trial. Pediatrics. 2014 Aug;134(2):e454-63. doi: 10.1542/peds.2013-3164. Epub 2014 Jul 21.
PubMed 25049350Fenson, L., Marchman, V., Thal, D., Dale, P., Reznick, S., & Bates, E. (2006). The MacArthur Communicative Development Inventories: User's guide and technical manual (2nd ed.). Baltimore: Brookes.
Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.
PubMed 7042457Kabat-Zinn, J. (1990). Full Catastrophe Living: Using the Wisdom of your Mind to Face Stress, Pain and Illness. New York: Dell Publishing.
Lord, C., Rutter, M., DiLavore, P., Risi, S., Gotham, K., & Bishop, S.L. (2012). Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2): Manual. Los Angeles: Western Psychological Services.
Mullen, E. M. (1994). Mullen Scales of Early Learning. Circle Pines, MN: American Guidance Service.
Rogers SJ, Estes A, Lord C, Vismara L, Winter J, Fitzpatrick A, Guo M, Dawson G. Effects of a brief Early Start Denver model (ESDM)-based parent intervention on toddlers at risk for autism spectrum disorders: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2012 Oct;51(10):1052-65. doi: 10.1016/j.jaac.2012.08.003. Epub 2012 Aug 28.
PubMed 23021480Spanier, G.B. (1989). Manual for the Dyadic Adjustment Scale. North Tonowanda, NY: Multi-Health Systems.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Mindfulness Training Enhance Early Evidence-based Parent-coaching Interventions for Autism Spectrum Disorder?: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03889821
- Acronym / sponsor ID
- MBSR and P-ESDM
- Conditions
- Autism Spectrum Disorder, Parents, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 11 Mar 2015 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 26 Mar 2019 (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.
Caregivers of children with autism spectrum disorder (ASD) report higher levels of depression and distress than caregivers of typically developing children as well as children with other developmental disabilities. The proposed work tests a novel treatment paradigm that blends Mindfulness Based Stress Reduction (MBSR) with an empirically supported and manualized parent training program (Parent-Implemented Early Start Denver Model [P-ESDM]). We hypothesize that directly treating parental distress, while simultaneously providing evidence-based parent training, may greatly enhance child-focused intervention and provide benefits that resonate across the family.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child-focused Treatment | Active comparator | Behavioral: Parent-implemented Early Start Denver ModelParticipants in this group participate in 12 sessions of the Parent-implemented Early Start Denver Model (P-ESDM). |
| Child- and Parent-focused Treatment | Experimental | Behavioral: Parent-implemented Early Start Denver Model, Behavioral: Mindfulness Based Stress ReductionParticipants in this group participate in 12 sessions of the Parent-implemented Early Start Denver Model (P-ESDM). Parents also participate in 6 separate, individual sessions of Mindfulness Based Stress Reduction (MBSR). |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Child has diagnosis of autism spectrum disorder
- Child at least 12 months of age but less than 36 months at time of consent
- Parent speaks and reads fluent English
Key exclusion criteria (1 listed)
- Severe child sensorimotor impairment that would impact participation in treatment
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 |
|---|---|---|
| Parent-implemented Early Start Denver ModelThe Parent-implemented Early Start Denver Model (P-ESDM; Rogers et al., 2012) consists of 12 consecutive sessions, each session approximately 1 hour long, that promote parental ability to support and interact with their young children with autism spectrum disorder (ASD). Intervention sessions are conducted in the clinic setting by therapists trained to fidelity by ESDM-certified parent trainers. The manualized intervention has a detailed parent-training curriculum, a specific coaching intervention method, and a therapist fidelity measure. Therapists introduce skills through descriptions, interaction, modeling, coaching, and feedback. | Behavioural | Child- and Parent-focused Treatment, Child-focused Treatment |
| Mindfulness Based Stress ReductionThe Mindfulness Based Stress Reduction (MBSR) protocol is derived from the work by Dykens et al. (2014), which is based on the stress reduction and relaxation program (Kabat-Zinn, 1982, 1990). In this study, it is offered as 6 weekly sessions that run concurrent with the P-ESDM intervention. Participants work one-on-one with a therapist for instruction and practice in mindfulness skills as well as discussions of stress, coping, and homework assignments. | Behavioural | Child- and Parent-focused Treatment |
Primary outcome
Change in parental stress
Time frame: Baseline to end of study (Every 6 weeks for 9 months)
The Parenting Stress Index - Short Form, Third Edition (PSI-SF; Abidin, 1995), is a 36-item measure that yields three subscale scores (Parent Child Dysfunctional Interaction, Parenting Distress, Difficult Child) used in present analyses. Each item is rated as by parents as: SA (strongly agree), A (agree), NS (not sure), D (disagree), SD (strongly disagree). Scores are converted to percentile ranks, with higher scores indicating higher levels of stress. Percentile ranks of 15-80 considered typical, and ranks of 81 and above are considered high.
Change in parental depression
Time frame: Baseline to end of study (Every 6 weeks for 9 months)
Parents completed the Beck Depression Inventory (BDI; Beck et al., 1984). This instrument consists of 21 items, with higher scores reflecting higher levels of symptomatology.
Change in parental anxiety
Time frame: Baseline to end of study (Every 6 weeks for 9 months)
Parents completed the Beck Anxiety Inventory (BAI; Beck et al., 1988). This instrument consists of 21 items, with higher scores reflecting higher levels of symptomatology.
Change in parental mindfulness
Time frame: Baseline to end of study (Every 6 weeks for 9 months)
. Parents completed the Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006). The FFMQ consists of 44 items that yield five subscales: Observing, Describing, Acting with Awareness, Nonreactivity, and Nonjudging. Higher scores indicate more mindfulness.
Change in parent relationship quality
Time frame: Baseline to end of study (Every 6 weeks for 9 months)
The Dyadic Adjustment Scale (DAS; Spanier, 1989) is a 32-item measure that assesses relationship satisfaction. It includes four subscales scored using a mix of Likert and dichotomous responses. Higher scores indicate higher relationship satisfaction.
Change in parental life satisfaction
Time frame: Baseline to end of study (Every 6 weeks for 9 months)
Parents completed the Satisfaction with Life Scale (SLS; Diener et al., 1984). The SLS is a 5-item measure of subjective wellbeing, with each item scored along a 7-point Likert scale (higher scores indicate more satisfaction).
Change in parental sleep quality
Time frame: Baseline to end of study (Every 6 weeks for 9 months)
Parents completed the Insomnia Severity Index (ISI; Bastien et al., 2011). The ISI consists of seven items scored from 0-4, with higher scores reflecting more sleep-related impairment.
5 secondary outcomes
Change in child autism symptom severity
Time frame: Baseline, end of treatment (12 weeks), end of study (9 months)
Change in child cognitive functioning
Time frame: Baseline, end of treatment (12 weeks), end of study (9 months)
Change in child adaptive behavior
Time frame: Baseline, end of treatment (12 weeks), end of study (9 months)
Change in child problem behaviors
Time frame: Baseline, end of treatment (12 weeks), end of study (9 months)
Change in child communication behaviors
Time frame: Baseline, end of treatment (12 weeks), end of study (9 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 26 Mar 2019.
- BackgroundAbidin, R. (1995). Parenting Stress Index, 3rd Edition. Lutz, FL: Psychological Assessment Resources.
- BackgroundAchenbach, T. M. (2001). Achenbach Child Behavior Checklist. Burlington, VT: ASEBA.
- Background: PubMed 16443717Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
- Background: PubMed 3204199Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
- BackgroundBeck AT, Steer RA., Brown GK . Manual for the Beck Depression Inventory-II. 1996. San Antonio: Psychological Corporation.
- Background: PubMed 11438246Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
- Background: PubMed 16367493Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
- Background: PubMed 25049350Dykens EM, Fisher MH, Taylor JL, Lambert W, Miodrag N. Reducing distress in mothers of children with autism and other disabilities: a randomized trial. Pediatrics. 2014 Aug;134(2):e454-63. doi: 10.1542/peds.2013-3164. Epub 2014 Jul 21.
- BackgroundFenson, L., Marchman, V., Thal, D., Dale, P., Reznick, S., & Bates, E. (2006). The MacArthur Communicative Development Inventories: User's guide and technical manual (2nd ed.). Baltimore: Brookes.
- Background: PubMed 7042457Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.
- BackgroundKabat-Zinn, J. (1990). Full Catastrophe Living: Using the Wisdom of your Mind to Face Stress, Pain and Illness. New York: Dell Publishing.
- BackgroundLord, C., Rutter, M., DiLavore, P., Risi, S., Gotham, K., & Bishop, S.L. (2012). Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2): Manual. Los Angeles: Western Psychological Services.
- Individual participant dataSharing planned: Yes. Data sharing procedures will adhere to guidelines established by the NIH sponsored National Database for Autism Research (NDAR). NDAR is a scalable informatics platform for ASD relevant data. NDAR was developed to share data and facilitate collaboration across the ASD field. We will participate in this system for sharing data in hopes that such sharing will accelerate research progress by allowing re-analysis of data, as well as re-aggregation, integration, and rigorous comparison with other data, tools, and methods. We will submit both descriptive and experimental data (http://ndar.nih.gov/).
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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.
Amy S Weitlauf, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-implemented Early Start Denver Model and Mindfulness Based Stress Reduction in people with Autism Spectrum Disorder and Parents, run by Vanderbilt University Medical Center 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 3 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 26 Mar 2019. 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 parental stress (time frame: Baseline to end of study (Every 6 weeks for 9 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03889821, which also lists 17 linked publications.
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 26 Mar 2019.