Autism Spectrum DisorderNCT04097457
Group Based Parent Training for Children With Autism and Disruptive Behaviors
A study testing "Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018) in people with Autism Spectrum Disorder, run by Hebrew University of Jerusalem at 1 site in Israel.
Trial summary
The goal of the study is to providing parents of children diagnosed with autism spectrum disorders (ASD) and disruptive behaviors essential skills to manage their children's behaviors using an evidence based parent training protocol. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- "Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Oct 2017to 2 Jan 2021
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Formal ASD diagnosis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Judah Koller, PsyD contact
Israel1 site, 1 recruiting
- Recruiting
The Hebrew university
Jerusalem
Eyal Cohen, MA, 0525212066, eyal.cohen2@mail.huji.ac.il
About this study
Official title: A Community-implemented, Parent-mediated, Group Intervention for Children With Autism Spectrum Disorder (ASD) and Disruptive Behaviors.
The goal of the study is to providing parents of children diagnosed with autism spectrum disorders (ASD) and disruptive behaviors essential skills to manage their children's behaviors using an evidence based parent training protocol. Beyond the feasibility of delivering an evidence based intervention in groups and with community partners, primary and secondary outcomes in both the children and the parents who participated in the study are assessed during and after the intervention process
Read the detailed description
the investigators will deliver parent-mediated, community-implemented, group intervention for parents of young children with autism and disruptive behavior. The intervention is 11-12 weeks and will take place in community settings such as special education schools and community centers.
Within these meetings parents will be given the skills to understand their child's behavior and work to modify those that are clinically disruptive to the child and their environment.
Groups will be facilitated by student therapists under direct weekly supervision of a Board Certified Behavior Analyst (BCBA). Data will be collected before, after, and throughout the intervention, primarily by parent-report with one teacher-report measure and two (pre/post) filmed parent-child interactions.
The primary desired outcome is a measurable decrease in the child's disruptive behaviors and an increase in their adaptive behaviors. Although the intervention specifically targets disruptive behavior, we expect to see consequent improvement in a number of linked domains. These represent desired secondary outcomes.
First, as a result of receiving concrete skills and seeing improvement in their child's behavior, as well as due to participation in the group with other families, a reduction in parental stress and an increase in their perceived self-efficacy should occur, as well as a reduction in the stress of the non-participating parent.
Second, after the reduction in disruptive behaviors there should be an improvement in autism symptomatology. Improvements in behavior will allow the child to benefit more from their environments, leading to social and developmental gains.
In the context of the current study, the impact of the intervention on family accommodation is also assessed, hypothesizing that by learning how to analyse and modify behaviors, parents are gaining a broader insight into the impact their own behaviors have on that of their children.
- Conditions
- Autism Spectrum Disorder
- Being tested
- "Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018)
- 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 training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018)Behavioural
The intervention is a short term parent training program based on behavioral principles, which can be delivered by trained therapist. The manual includes eleven core sessions, home visit session, follow-up telephone booster sessions and seven supplemental sessions, designed to be delivered individually to parents in an outpatient setting.
The protocol will be administered to groups of 3-4 parents, with a quantitative pretest-post test design evaluated at five time points, including a follow up at one month post intervention. The protocol will be administered in various community and educational locations, such as schools and community centers
| Study group | Role | What they receive |
|---|---|---|
| Parent mediated intervention (PMI) group | Experimental | A short term parent training protocol based on behavioral principles, which is delivered by trained therapists. The protocol includes eleven core sessions, a home visit session, follow-up telephone booster sessions and seven supplemental sessions, designed to be delivered to parents in an outpatient and home settings. The protocol is administered to groups of 4 families. Receives: Behavioral: "Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018) |
| Waitlist control | Experimental | Families will be recruited and will fill out measure for 3 months prior to participation and will then join the active intervention Receives: Behavioral: "Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018) |
| Individual | Experimental | A short term parent training protocol based on behavioral principles, which is delivered by trained therapists. The protocol includes eleven core sessions, a home visit session, follow-up telephone booster sessions and seven supplemental sessions, designed to be delivered to parents in an outpatient and home settings. In this arm the protocol is administered individually to families. Receives: Behavioral: "Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects (Aman, M. G., Singh, N. N., Stewart, A. W., & Field, C. J.,1985)
A caregiver and teacher report measure of disruptive behaviors including 58 items, each rated on a four-point Likert scale (0-3), with higher scores indicative of more severe problem behavior. Includes five subscales: Irritability (tantrums, aggression and self-injury, 15 items); Social Withdrawal (16 items); Stereotypic Behavior (7 items); Hyperactivity (16 items); and Inappropriate Speech (4 items). In children with ASD, the ABC subscales demonstrate adequate internal consistencies (α=.77-.94) and convergent validity (Kaat, Lecavalier, \& Aman, 2014).
The measure will be administered at different time points on order to follow changes in the disruptive behaviors of the participants.
Measured: Administered to parents and teachers at baseline, 4 weeks, 8 weeks, 12 weeks (end-point), 16 weeks and 20 weeks (follow-up). The measure will be administered at different time points to follow changes in severe disruptive behaviors of the participants
Home Situations Questionnaire (HSQ) (Barkley & Murphy, 1998)
A caregiver-rated scale for child noncompliance across 24 everyday situations. Each item is rated as a problem: ''yes'' or ''no''; ''yes'' items are then scored from 1 (mild) to 9 (severe), on two subscales: 'Demand-Specific' and 'Socially Inflexible' (Chowdhury et al. 2010). The total severity score is divided by 24 to obtain a per item mean.
Measured: Administered to parents at baseline, 12 weeks and at 20 weeks.The measure will be administered at different time points in order to follow changes in compliance levels of the participants.
Social Responsiveness Scale (SRS) (Constantino & Gruber, 2005)
A caregiver - and teacher-report measure of child social competence with 65 items, each rated on a four-point Likert scale (1-4), with higher scores indicative of more problematic social-related behaviors, in the domains of social awareness, social cognition, social communication, social motivation, and autistic mannerisms (e.g., restricted or repetitive behaviors). All subscales have acceptable internal consistency (α = .77-.92) and test-retest reliability (Constantino et al., 2003)
Measured: Administered to parents at baseline, 12 weeks and at 20 weeks. The measure will be administered at different time points in order to follow changes in social-related behaviors of the participants.
Adaptive Behavior Assessment System (ABAS-II)
A comprehensive evaluation tool, covering the ten adaptive behavior deficit areas defined by the DSM-5 (APA, 2013), and it is recommended for use as part of the standard ASD diagnostic evaluation process, by the Ministry of Health in Israel. The ABAS-II provides standard scores on the following core domains: Communication; Use of Community Resources; Academic Functional Skills; Daily Living Skills; Health and Security; Leisure; Self-Help; Self-Direction; Socialization and Occupation, as well as a General Adaptive Behavior Composite Score (GAC). Items are rated on a four-point Likert scale (0-3), with higher scores indicative of higher adaptive functioning.
Measured: administered to participating parents at baseline, 12 weeks and at 20 weeks. The measure will be administered at different time points in order to follow changes related to adaptive behaviors of the participants.
Secondary outcomes (1)
Parenting Stress Index Short Version (PSI-SR) (Abidin, 1990)
A self-report inventory designed to measure the overall level of parenting stress an individual is experiencing and it examine stressors associated specifically with the parental role and do not include stresses associated with other life roles and events. The PSI-SR has strong psychometric properties and has been used in a number of studies of autism and parent training, and was also found valid and reliable when tested on Israeli parents (sharf 1989; Turkel 2002). It contains 36 items, each rated on a five-point Likert scale (1-5), with higher scores indicative of more parenting stress and includes Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI) and Difficult Child (DC) sub-scales.
Measured: administered to all participating and non-participating parents at baseline, 12 weeks and at 20 weeks.The measure will be administered at different time points in order to follow changes in stress levels of parent participants.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start2 Oct 2017
- Primary completion2 Sep 2020 (estimated)
- Study completion2 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyal Cohen, Hebrew University of Jerusalem
- Investigators
- Judah Koller, PsyD, Principal investigator, Hebrew University in Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097457
- Sponsor's protocol ID
- GroupPT ASD
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bearss K, Johnson C, Handen B, Smith T, Scahill L. A pilot study of parent training in young children with autism spectrum disorders and disruptive behavior. J Autism Dev Disord. 2013 Apr;43(4):829-40. doi: 10.1007/s10803-012-1624-7.
PubMed 22941342Bearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, McAdam DB, Butter E, Stillitano C, Minshawi N, Sukhodolsky DG, Mruzek DW, Turner K, Neal T, Hallett V, Mulick JA, Green B, Handen B, Deng Y, Dziura J, Scahill L. Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: a randomized clinical trial. JAMA. 2015 Apr 21;313(15):1524-33. doi: 10.1001/jama.2015.3150.
PubMed 25898050Bearss K, Lecavalier L, Minshawi N, Johnson C, Smith T, Handen B, Sukhodolsky D, Aman M, Swiezy N, Butter E, Scahill L. Toward an exportable parent training program for disruptive behaviors in autism spectrum disorders. Neuropsychiatry (London). 2013 Apr;3(2):169-180. doi: 10.2217/npy.13.14.
PubMed 23772233Michelson D, Davenport C, Dretzke J, Barlow J, Day C. Do evidence-based interventions work when tested in the "real world?" A systematic review and meta-analysis of parent management training for the treatment of child disruptive behavior. Clin Child Fam Psychol Rev. 2013 Mar;16(1):18-34. doi: 10.1007/s10567-013-0128-0.
PubMed 23420407
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-implemented, Parent-mediated, Group Intervention for Children With Autism Spectrum Disorder (ASD) and Disruptive Behaviors.
- ClinicalTrials.gov ID
- NCT04097457
- Acronym / sponsor ID
- GroupPT ASD
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 2 Sep 2020 (estimated)
- Study completion
- 2 Jan 2021 (estimated)
- First posted
- 20 Sep 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.
The goal of the study is to providing parents of children diagnosed with autism spectrum disorders (ASD) and disruptive behaviors essential skills to manage their children's behaviors using an evidence based parent training protocol. Beyond the feasibility of delivering an evidence based intervention in groups and with community partners, primary and secondary outcomes in both the children and the parents who participated in the study are assessed during and after the intervention process
Detailed description
the investigators will deliver parent-mediated, community-implemented, group intervention for parents of young children with autism and disruptive behavior. The intervention is 11-12 weeks and will take place in community settings such as special education schools and community centers.
Within these meetings parents will be given the skills to understand their child's behavior and work to modify those that are clinically disruptive to the child and their environment.
Groups will be facilitated by student therapists under direct weekly supervision of a Board Certified Behavior Analyst (BCBA). Data will be collected before, after, and throughout the intervention, primarily by parent-report with one teacher-report measure and two (pre/post) filmed parent-child interactions.
The primary desired outcome is a measurable decrease in the child's disruptive behaviors and an increase in their adaptive behaviors. Although the intervention specifically targets disruptive behavior, we expect to see consequent improvement in a number of linked domains. These represent desired secondary outcomes.
First, as a result of receiving concrete skills and seeing improvement in their child's behavior, as well as due to participation in the group with other families, a reduction in parental stress and an increase in their perceived self-efficacy should occur, as well as a reduction in the stress of the non-participating parent.
Second, after the reduction in disruptive behaviors there should be an improvement in autism symptomatology. Improvements in behavior will allow the child to benefit more from their environments, leading to social and developmental gains.
In the context of the current study, the impact of the intervention on family accommodation is also assessed, hypothesizing that by learning how to analyse and modify behaviors, parents are gaining a broader insight into the impact their own behaviors have on that of their children.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parent mediated intervention (PMI) group | Experimental | Behavioral: "Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018)A short term parent training protocol based on behavioral principles, which is delivered by trained therapists. The protocol includes eleven core sessions, a home visit session, follow-up telephone booster sessions and seven supplemental sessions, designed to be delivered to parents in an outpatient and home settings. The protocol is administered to groups of 4 families. |
| Waitlist control | Experimental | Behavioral: "Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018)Families will be recruited and will fill out measure for 3 months prior to participation and will then join the active intervention |
| Individual | Experimental | Behavioral: "Parent training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018)A short term parent training protocol based on behavioral principles, which is delivered by trained therapists. The protocol includes eleven core sessions, a home visit session, follow-up telephone booster sessions and seven supplemental sessions, designed to be delivered to parents in an outpatient and home settings. In this arm the protocol is administered individually to families. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Formal ASD diagnosis
Key exclusion criteria (1 listed)
- -
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 training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018)The intervention is a short term parent training program based on behavioral principles, which can be delivered by trained therapist. The manual includes eleven core sessions, home visit session, follow-up telephone booster sessions and seven supplemental sessions, designed to be delivered individually to parents in an outpatient setting. The protocol will be administered to groups of 3-4 parents, with a quantitative pretest-post test design evaluated at five time points, including a follow up at one month post intervention. The protocol will be administered in various community and educational locations, such as schools and community centers | Behavioural | Individual, Parent mediated intervention (PMI) group, Waitlist control |
Primary outcome
The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects (Aman, M. G., Singh, N. N., Stewart, A. W., & Field, C. J.,1985)
Time frame: Administered to parents and teachers at baseline, 4 weeks, 8 weeks, 12 weeks (end-point), 16 weeks and 20 weeks (follow-up). The measure will be administered at different time points to follow changes in severe disruptive behaviors of the participants
A caregiver and teacher report measure of disruptive behaviors including 58 items, each rated on a four-point Likert scale (0-3), with higher scores indicative of more severe problem behavior. Includes five subscales: Irritability (tantrums, aggression and self-injury, 15 items); Social Withdrawal (16 items); Stereotypic Behavior (7 items); Hyperactivity (16 items); and Inappropriate Speech (4 items). In children with ASD, the ABC subscales demonstrate adequate internal consistencies (α=.77-.94) and convergent validity (Kaat, Lecavalier, \& Aman, 2014). The measure will be administered at different time points on order to follow changes in the disruptive behaviors of the participants.
Home Situations Questionnaire (HSQ) (Barkley & Murphy, 1998)
Time frame: Administered to parents at baseline, 12 weeks and at 20 weeks.The measure will be administered at different time points in order to follow changes in compliance levels of the participants.
A caregiver-rated scale for child noncompliance across 24 everyday situations. Each item is rated as a problem: ''yes'' or ''no''; ''yes'' items are then scored from 1 (mild) to 9 (severe), on two subscales: 'Demand-Specific' and 'Socially Inflexible' (Chowdhury et al. 2010). The total severity score is divided by 24 to obtain a per item mean.
Social Responsiveness Scale (SRS) (Constantino & Gruber, 2005)
Time frame: Administered to parents at baseline, 12 weeks and at 20 weeks. The measure will be administered at different time points in order to follow changes in social-related behaviors of the participants.
A caregiver - and teacher-report measure of child social competence with 65 items, each rated on a four-point Likert scale (1-4), with higher scores indicative of more problematic social-related behaviors, in the domains of social awareness, social cognition, social communication, social motivation, and autistic mannerisms (e.g., restricted or repetitive behaviors). All subscales have acceptable internal consistency (α = .77-.92) and test-retest reliability (Constantino et al., 2003)
Adaptive Behavior Assessment System (ABAS-II)
Time frame: administered to participating parents at baseline, 12 weeks and at 20 weeks. The measure will be administered at different time points in order to follow changes related to adaptive behaviors of the participants.
A comprehensive evaluation tool, covering the ten adaptive behavior deficit areas defined by the DSM-5 (APA, 2013), and it is recommended for use as part of the standard ASD diagnostic evaluation process, by the Ministry of Health in Israel. The ABAS-II provides standard scores on the following core domains: Communication; Use of Community Resources; Academic Functional Skills; Daily Living Skills; Health and Security; Leisure; Self-Help; Self-Direction; Socialization and Occupation, as well as a General Adaptive Behavior Composite Score (GAC). Items are rated on a four-point Likert scale (0-3), with higher scores indicative of higher adaptive functioning.
1 secondary outcome
Parenting Stress Index Short Version (PSI-SR) (Abidin, 1990)
Time frame: administered to all participating and non-participating parents at baseline, 12 weeks and at 20 weeks.The measure will be administered at different time points in order to follow changes in stress levels of parent participants.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Background: PubMed 22941342Bearss K, Johnson C, Handen B, Smith T, Scahill L. A pilot study of parent training in young children with autism spectrum disorders and disruptive behavior. J Autism Dev Disord. 2013 Apr;43(4):829-40. doi: 10.1007/s10803-012-1624-7.
- Background: PubMed 25898050Bearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, McAdam DB, Butter E, Stillitano C, Minshawi N, Sukhodolsky DG, Mruzek DW, Turner K, Neal T, Hallett V, Mulick JA, Green B, Handen B, Deng Y, Dziura J, Scahill L. Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: a randomized clinical trial. JAMA. 2015 Apr 21;313(15):1524-33. doi: 10.1001/jama.2015.3150.
- Background: PubMed 23772233Bearss K, Lecavalier L, Minshawi N, Johnson C, Smith T, Handen B, Sukhodolsky D, Aman M, Swiezy N, Butter E, Scahill L. Toward an exportable parent training program for disruptive behaviors in autism spectrum disorders. Neuropsychiatry (London). 2013 Apr;3(2):169-180. doi: 10.2217/npy.13.14.
- Background: PubMed 23420407Michelson D, Davenport C, Dretzke J, Barlow J, Day C. Do evidence-based interventions work when tested in the "real world?" A systematic review and meta-analysis of parent management training for the treatment of child disruptive behavior. Clin Child Fam Psychol Rev. 2013 Mar;16(1):18-34. doi: 10.1007/s10567-013-0128-0.
- ProtocolLink provided by the sponsor.
- 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.
Judah Koller, PsyD contact
Judah Koller, PsyD principal investigator
Hebrew University in Jerusalem
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 training for disruptive behaviors" manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018) in people with Autism Spectrum Disorder, run by Hebrew University of Jerusalem at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eyal Y Cohen, MA (0525212066, eyal.cohen2@mail.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects (Aman, M. G., Singh, N. N., Stewart, A. W., & Field, C. J.,1985) (time frame: Administered to parents and teachers at baseline, 4 weeks, 8 weeks, 12 weeks (end-point), 16 weeks and 20 weeks (follow-up). The measure will be administered at different time points to follow changes in severe disruptive behaviors of the participants). The study lists 4 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 NCT04097457, which also lists 4 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 20 Sep 2019.