Autism Spectrum DisorderIY-ASDNCT03300128
Incredible Years Program for Parents of Children with Autism
A study testing Incredible Years - ASD and Circle of Parents in people with Autism Spectrum Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Early intervention for children with Autism Spectrum Disorder (ASD), particularly with parent involvement, is beneficial for both children and their families. However, few interventions have been rigorously tested which explicitly address parent and family outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Incredible Years - ASD and Circle of Parents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 10 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent or primary caregiver of a child ages 2 to 8 with an autism spectrum disorder
- Must live in Onslow County or surrounding county
Who cannot join
- Parent is younger than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Onslow County Partnership for Children
Jacksonville, North Carolina, 28546
About this study
Official title: Evaluation of Incredible Years Parenting Program for Caregivers of Children with Autism
Early intervention for children with Autism Spectrum Disorder (ASD), particularly with parent involvement, is beneficial for both children and their families. However, few interventions have been rigorously tested which explicitly address parent and family outcomes. This study will test the effectiveness of "The Incredible Years Parent Program for Autism Spectrum and Language Delays" (IY-ASD) program for parents of children with ASD ages 2-8 in a community-based setting, compared to a parent support program, "Circle of Parents." The investigators will assess parent stress, caregiver coping, child behavior, parenting practices of participants. In addition, the investigators will report on participants' satisfaction with IY-ASD, through parent interviews and satisfaction surveys.
Read the detailed description
"The Incredible Years" refers to a suite of developmentally appropriate, group-based interventions targeting parenting, children, and teachers. IY-ASD is an adapted version of the Basic parent training program, which uses a simple and low-cost format to develop skills in problem-solving coping, stress management, and communication. "The Incredible Years" has decades of evidence pointing to improved levels of parent stress, depression, and coping skills, as well as decreased negative child outcomes such as aggressive behavior in a broad array of diverse populations. The program has been used extensively in the United Kingdom and Sweden. Cost-effectiveness analyses have been performed with positive results in England. "The Incredible Years" is based on attachment theory and social learning theory.The goals of "The Incredible Years" parent intervention - communication, problem-solving, and stress management - are critically important to this population. Parents with children with special needs tend to interact with teachers, healthcare professionals, and other adults more often than parents whose children do not have disabilities. Thus, building a strong foundation early to begin to problem solve, communicate effectively, and navigate healthcare and special education systems can reduce some stress the parent might experience in the future.
The Incredible Years Parent Program for Autism Spectrum and Language Delays (IY-ASD). IY-ASD will be delivered over a 14-week period. The current research aims to rigorously test IY-ASD in a community-based setting using a randomized design. The investigators will compare IY-ASD to a usual practice, a parent support group currently offered at Onslow County Partnership for Children, "Circle of Parents." "Circle of Parents" is an open group which is led by a parent leader. These groups generally meet weekly or biweekly. Participants are encouraged to share resources and other support both during groups, and between meetings. Free childcare and meals are also offered during "Circle of Parents" meetings. Using a randomized design, the investigators will evaluate a parent intervention for caregivers of children with Autism Spectrum Disorder (ASD), compared to a parent support group. Over a four-year period, the investigators seek to:
- Recruit approximately 105 parents and other primary caregivers to participate in either an IY-ASD or "Circle of Parents" group;
- Measure parenting stress, parent coping mechanisms, parenting practices, and child behavior of participants and their children, at baseline and posttest (pre- and post-intervention);
- Compare outcomes of parents completing IY-ASD versus those in "Circle of Parents" group;
- Evaluate changes in parent and child outcomes from post-intervention to 3-month follow-up in IY-ASD participants; and,
- Elicit information from IY-ASD participants to assess satisfaction and improve future use of IY-ASD in the ASD population.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Incredible Years - ASD, Circle of Parents
- Keywords
- autism, parenting, Incredible Years
- 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.
Incredible Years - ASDBehavioural
Also called Incredible Years
The IY-ASD intervention is designed for parents of children with autism spectrum disorder. The programs uses a mix of videos, collaborative brainstorming sessions, and role plays to deliver content on child-directed play and positive discipline practices.
Circle of ParentsOther
"Circle of Parents" is an open parent support group led by a parent leader. Participants are encouraged to share resources and other support both during groups, and between meetings.
| Study group | Role | What they receive |
|---|---|---|
| Incredible Years - ASD | Experimental | The intervention, The Incredible Years Parent Program for Autism Spectrum and Language Delays (IY-ASD; more information is here: http://www.incredibleyears.com/programs/parent/autism-spectrum-language-delays/) is a 14-week course that meets for 2 hours every week. Ideally, an IY-ASD group will be composed of approximately 10 parents and other primary caregivers of children who have autism. Receives: Behavioral: Incredible Years - ASD |
| Circle of Parents | Active comparator | "Circle of Parents," the comparison condition, is an open parent support group led by a parent leader. (For more information, see http://circleofparents.org/). Participants are encouraged to share resources and other support both during groups, and between meetings. Receives: Other: Circle of Parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child behavior
Eyberg Child Behavior Inventory (ECBI) - This measure includes 36 items that assess typical problems reported by parents of conduct-disordered children. Items are rated on intensity and problem scales; the two subscales are combined for a composite score.
Measured: Change from baseline at 14 weeks and at 3 months
Change in parent stress
Parenting Stress Index-Short Form (PSI-SF) - The PSI Short Form (PSI/SF) is a direct derivative of the Parenting Stress Index (PSI) full-length test. All 36 items on the Short Form are contained on the Long Form with identical wording and are written at a 5th-grade reading level, for parents of children 12 years and younger. The PSI/SF yields a Total Stress score from three scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child.
Measured: Change from baseline at 14 weeks and at 3 months
Secondary outcomes (5)
Change in coping mechanisms
Brief COPE - This measures assesses several types of coping mechanisms used to address stress.
Measured: Change from baseline at 14 weeks and at 3 months
Change in parenting practices
Parent Practices Inventory (PPI) - This questionnaire was adapted from the Oregon Social Learning Center's (OSLC) discipline questionnaire and revised for young children. There are 72 items assessing various subscales of parenting behavior.
Measured: Change from baseline at 14 weeks and at 3 months
Change in depression, anxiety, and stress
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.
Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content.
Measured: Change from baseline at 14 weeks and at 3 months
Satisfaction survey
This survey was developed for the Incredible Years and can be found in the Incredible Years manual. It is not standardized.
Measured: At treatment completion (approximately 14 weeks after baseline)
Weekly IY-ASD evaluation
This survey was developed for the Incredible Years and can be found in the Incredible Years manual. It is not standardized.
Measured: Weekly throughout treatment (14 weeks total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Jun 2017
- Primary completion31 May 2018
- Study completion10 Dec 2018
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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 University of Maryland, BaltimoreThe 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
- Participants will be randomized 1:1 into a treatment group (IY-ASD parent training program) or comparison group ("Circle of Parents" parent support program). The 14-week parent groups will be offered twice per year. Once participants are enrolled in the study, they will complete a set of baseline measures (described in Section 5). The study coordinator will provide Dr. Dababnah a complete list of participants (unique identifiers only which do not contain identifiable information). Dr. Dababnah will randomize participants using a computer-generated randomization plan into either IY-ASD or "Circle of Parents" support group. While participants and the research team will not be blinded to group assignment, only the PI and her Research Assistant(s) at UMB will have access to the randomization plan. Dr. Dababnah and her team will review baseline measures for each period after individuals have been randomized.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Dababnah, University of Maryland, Baltimore
- Investigators
- Sarah Dababnah, PhD, Principal investigator, School of Social Work University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300128
- Sponsor's protocol ID
- HP-00074617
- Acronym
- IY-ASD
- Status last verified
- Dec 2019
- First submitted
- 22 Sep 2017
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Axberg U, Hansson K, Broberg AG. Evaluation of the Incredible Years Series - an open study of its effects when first introduced in Sweden. Nord J Psychiatry. 2007;61(2):143-51. doi: 10.1080/08039480701226120.
PubMed 17454729Edwards RT, Ceilleachair A, Bywater T, Hughes DA, Hutchings J. Parenting programme for parents of children at risk of developing conduct disorder: cost effectiveness analysis. BMJ. 2007 Mar 31;334(7595):682. doi: 10.1136/bmj.39126.699421.55. Epub 2007 Mar 9.
PubMed 17350965Kim E, Cain KC, Webster-Stratton C. The preliminary effect of a parenting program for Korean American mothers: a randomized controlled experimental study. Int J Nurs Stud. 2008 Sep;45(9):1261-73. doi: 10.1016/j.ijnurstu.2007.10.002. Epub 2007 Nov 8.
PubMed 17996239Webster-Stratton,C. (2011). The Incredible Years: Parents, teachers, and children's training series: Program content, methods, research and dissemination. Seattle, WA: Incredible Years, Inc.
Jones K, Daley D, Hutchings J, Bywater T, Eames C. Efficacy of the Incredible Years Basic parent training programme as an early intervention for children with conduct problems and ADHD. Child Care Health Dev. 2007 Nov;33(6):749-56. doi: 10.1111/j.1365-2214.2007.00747.x.
PubMed 17944785Reid MJ, Webster-Stratton C, Beauchaine TP. Parent training in head start: a comparison of program response among African American, Asian American, Caucasian, and Hispanic mothers. Prev Sci. 2001 Dec;2(4):209-27. doi: 10.1023/a:1013618309070.
PubMed 11833925Melhuish EC. Parenting training improves problem behaviour in children at risk of conduct disorder. Evid Based Ment Health. 2007 Nov;10(4):125. doi: 10.1136/ebmh.10.4.125. No abstract available.
PubMed 17962687Smith LE, Seltzer MM, Tager-Flusberg H, Greenberg JS, Carter AS. A comparative analysis of well-being and coping among mothers of toddlers and mothers of adolescents with ASD. J Autism Dev Disord. 2008 May;38(5):876-89. doi: 10.1007/s10803-007-0461-6.
PubMed 17924181Dababnah S, Parish SL. A Comprehensive Literature Review of Randomized Controlled Trials for Parents of Young Children with Autism Spectrum Disorder. J Evid Inf Soc Work. 2016 May-Jun;13(3):277-92. doi: 10.1080/23761407.2015.1052909. Epub 2015 Jul 15.
PubMed 26177069Dababnah S, Parish SL. Feasibility of an empirically based program for parents of preschoolers with autism spectrum disorder. Autism. 2016 Jan;20(1):85-95. doi: 10.1177/1362361314568900. Epub 2015 Feb 25.
PubMed 25717131Dababnah S, Parish SL. Incredible Years program tailored to parents of preschoolers with autism: Pilot results. Research on Social Work Practice 26(4): 372-385. https://doi.org/10.1177/1049731514558004
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Incredible Years Parenting Program for Caregivers of Children with Autism
- ClinicalTrials.gov ID
- NCT03300128
- Acronym / sponsor ID
- IY-ASD / HP-00074617
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, parenting, Incredible Years
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 3 Oct 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.
Early intervention for children with Autism Spectrum Disorder (ASD), particularly with parent involvement, is beneficial for both children and their families. However, few interventions have been rigorously tested which explicitly address parent and family outcomes. This study will test the effectiveness of "The Incredible Years Parent Program for Autism Spectrum and Language Delays" (IY-ASD) program for parents of children with ASD ages 2-8 in a community-based setting, compared to a parent support program, "Circle of Parents." The investigators will assess parent stress, caregiver coping, child behavior, parenting practices of participants. In addition, the investigators will report on participants' satisfaction with IY-ASD, through parent interviews and satisfaction surveys.
Detailed description
"The Incredible Years" refers to a suite of developmentally appropriate, group-based interventions targeting parenting, children, and teachers. IY-ASD is an adapted version of the Basic parent training program, which uses a simple and low-cost format to develop skills in problem-solving coping, stress management, and communication. "The Incredible Years" has decades of evidence pointing to improved levels of parent stress, depression, and coping skills, as well as decreased negative child outcomes such as aggressive behavior in a broad array of diverse populations. The program has been used extensively in the United Kingdom and Sweden. Cost-effectiveness analyses have been performed with positive results in England. "The Incredible Years" is based on attachment theory and social learning theory.The goals of "The Incredible Years" parent intervention - communication, problem-solving, and stress management - are critically important to this population. Parents with children with special needs tend to interact with teachers, healthcare professionals, and other adults more often than parents whose children do not have disabilities. Thus, building a strong foundation early to begin to problem solve, communicate effectively, and navigate healthcare and special education systems can reduce some stress the parent might experience in the future.
The Incredible Years Parent Program for Autism Spectrum and Language Delays (IY-ASD). IY-ASD will be delivered over a 14-week period. The current research aims to rigorously test IY-ASD in a community-based setting using a randomized design. The investigators will compare IY-ASD to a usual practice, a parent support group currently offered at Onslow County Partnership for Children, "Circle of Parents." "Circle of Parents" is an open group which is led by a parent leader. These groups generally meet weekly or biweekly. Participants are encouraged to share resources and other support both during groups, and between meetings. Free childcare and meals are also offered during "Circle of Parents" meetings. Using a randomized design, the investigators will evaluate a parent intervention for caregivers of children with Autism Spectrum Disorder (ASD), compared to a parent support group. Over a four-year period, the investigators seek to:
- Recruit approximately 105 parents and other primary caregivers to participate in either an IY-ASD or "Circle of Parents" group;
- Measure parenting stress, parent coping mechanisms, parenting practices, and child behavior of participants and their children, at baseline and posttest (pre- and post-intervention);
- Compare outcomes of parents completing IY-ASD versus those in "Circle of Parents" group;
- Evaluate changes in parent and child outcomes from post-intervention to 3-month follow-up in IY-ASD participants; and,
- Elicit information from IY-ASD participants to assess satisfaction and improve future use of IY-ASD in the ASD population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 into a treatment group (IY-ASD parent training program) or comparison group ("Circle of Parents" parent support program). The 14-week parent groups will be offered twice per year. Once participants are enrolled in the study, they will complete a set of baseline measures (described in Section 5). The study coordinator will provide Dr. Dababnah a complete list of participants (unique identifiers only which do not contain identifiable information). Dr. Dababnah will randomize participants using a computer-generated randomization plan into either IY-ASD or "Circle of Parents" support group. While participants and the research team will not be blinded to group assignment, only the PI and her Research Assistant(s) at UMB will have access to the randomization plan. Dr. Dababnah and her team will review baseline measures for each period after individuals have been randomized.
| Arm | Type | Receives |
|---|---|---|
| Incredible Years - ASD | Experimental | Behavioral: Incredible Years - ASDThe intervention, The Incredible Years Parent Program for Autism Spectrum and Language Delays (IY-ASD; more information is here: http://www.incredibleyears.com/programs/parent/autism-spectrum-language-delays/) is a 14-week course that meets for 2 hours every week. Ideally, an IY-ASD group will be composed of approximately 10 parents and other primary caregivers of children who have autism. |
| Circle of Parents | Active comparator | Other: Circle of Parents"Circle of Parents," the comparison condition, is an open parent support group led by a parent leader. (For more information, see http://circleofparents.org/). Participants are encouraged to share resources and other support both during groups, and between meetings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parent or primary caregiver of a child ages 2 to 8 with an autism spectrum disorder
- Must live in Onslow County or surrounding county
Key exclusion criteria (1 listed)
- Parent is younger than 18 years old
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 |
|---|---|---|
| Incredible Years - ASDAlso: Incredible YearsThe IY-ASD intervention is designed for parents of children with autism spectrum disorder. The programs uses a mix of videos, collaborative brainstorming sessions, and role plays to deliver content on child-directed play and positive discipline practices. | Behavioural | Incredible Years - ASD |
| Circle of Parents"Circle of Parents" is an open parent support group led by a parent leader. Participants are encouraged to share resources and other support both during groups, and between meetings. | Other | Circle of Parents |
Primary outcome
Change in child behavior
Time frame: Change from baseline at 14 weeks and at 3 months
Eyberg Child Behavior Inventory (ECBI) - This measure includes 36 items that assess typical problems reported by parents of conduct-disordered children. Items are rated on intensity and problem scales; the two subscales are combined for a composite score.
Change in parent stress
Time frame: Change from baseline at 14 weeks and at 3 months
Parenting Stress Index-Short Form (PSI-SF) - The PSI Short Form (PSI/SF) is a direct derivative of the Parenting Stress Index (PSI) full-length test. All 36 items on the Short Form are contained on the Long Form with identical wording and are written at a 5th-grade reading level, for parents of children 12 years and younger. The PSI/SF yields a Total Stress score from three scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child.
5 secondary outcomes
Change in coping mechanisms
Time frame: Change from baseline at 14 weeks and at 3 months
Change in parenting practices
Time frame: Change from baseline at 14 weeks and at 3 months
Change in depression, anxiety, and stress
Time frame: Change from baseline at 14 weeks and at 3 months
Satisfaction survey
Time frame: At treatment completion (approximately 14 weeks after baseline)
Weekly IY-ASD evaluation
Time frame: Weekly throughout treatment (14 weeks total)
Results and safety
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Background: PubMed 17454729Axberg U, Hansson K, Broberg AG. Evaluation of the Incredible Years Series - an open study of its effects when first introduced in Sweden. Nord J Psychiatry. 2007;61(2):143-51. doi: 10.1080/08039480701226120.
- Background: PubMed 17350965Edwards RT, Ceilleachair A, Bywater T, Hughes DA, Hutchings J. Parenting programme for parents of children at risk of developing conduct disorder: cost effectiveness analysis. BMJ. 2007 Mar 31;334(7595):682. doi: 10.1136/bmj.39126.699421.55. Epub 2007 Mar 9.
- Background: PubMed 17996239Kim E, Cain KC, Webster-Stratton C. The preliminary effect of a parenting program for Korean American mothers: a randomized controlled experimental study. Int J Nurs Stud. 2008 Sep;45(9):1261-73. doi: 10.1016/j.ijnurstu.2007.10.002. Epub 2007 Nov 8.
- BackgroundWebster-Stratton,C. (2011). The Incredible Years: Parents, teachers, and children's training series: Program content, methods, research and dissemination. Seattle, WA: Incredible Years, Inc.
- Background: PubMed 17944785Jones K, Daley D, Hutchings J, Bywater T, Eames C. Efficacy of the Incredible Years Basic parent training programme as an early intervention for children with conduct problems and ADHD. Child Care Health Dev. 2007 Nov;33(6):749-56. doi: 10.1111/j.1365-2214.2007.00747.x.
- Background: PubMed 11833925Reid MJ, Webster-Stratton C, Beauchaine TP. Parent training in head start: a comparison of program response among African American, Asian American, Caucasian, and Hispanic mothers. Prev Sci. 2001 Dec;2(4):209-27. doi: 10.1023/a:1013618309070.
- Background: PubMed 17962687Melhuish EC. Parenting training improves problem behaviour in children at risk of conduct disorder. Evid Based Ment Health. 2007 Nov;10(4):125. doi: 10.1136/ebmh.10.4.125. No abstract available.
- Background: PubMed 17924181Smith LE, Seltzer MM, Tager-Flusberg H, Greenberg JS, Carter AS. A comparative analysis of well-being and coping among mothers of toddlers and mothers of adolescents with ASD. J Autism Dev Disord. 2008 May;38(5):876-89. doi: 10.1007/s10803-007-0461-6.
- Background: PubMed 26177069Dababnah S, Parish SL. A Comprehensive Literature Review of Randomized Controlled Trials for Parents of Young Children with Autism Spectrum Disorder. J Evid Inf Soc Work. 2016 May-Jun;13(3):277-92. doi: 10.1080/23761407.2015.1052909. Epub 2015 Jul 15.
- Background: PubMed 25717131Dababnah S, Parish SL. Feasibility of an empirically based program for parents of preschoolers with autism spectrum disorder. Autism. 2016 Jan;20(1):85-95. doi: 10.1177/1362361314568900. Epub 2015 Feb 25.
- BackgroundDababnah S, Parish SL. Incredible Years program tailored to parents of preschoolers with autism: Pilot results. Research on Social Work Practice 26(4): 372-385. https://doi.org/10.1177/1049731514558004
- 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.
Sarah Dababnah, PhD principal investigator
School of Social Work University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incredible Years - ASD and Circle of Parents in people with Autism Spectrum Disorder, run by University of Maryland, Baltimore 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 2 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: stopped early, as of the sponsor's last update on 26 Nov 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 was stopped early (reason given: Recruitment issues). 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 in child behavior (time frame: Change from baseline at 14 weeks and at 3 months). 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?
On the ClinicalTrials.gov record for NCT03300128, which also lists 11 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 Nov 2024.