Attention Deficit Disorder With HyperactivityPhase 4NCT02807870
Early Interventions in Children With Attention Deficit/Hyperactivity Disorder
A Phase 4 study testing Methylphenidate, Parental training and Psychoeducational groups for parents in people with Attention Deficit Disorder With Hyperactivity and Preschool Child, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Introduction: Attention deficit/hyperactivity disorder (ADHD) is one of the most prevalent mental disorders in children and is associated with important negative functional outcomes throughout development. The first signs and symptoms become apparent in preschool age. Read more about this study
- Who is it for?
- Ages 47 to 71 months
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Preschool Child
- What is being tested?
- Methylphenidate, Parental training and Psychoeducational groups for parents
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2016to 30 Jun 2020
- Phase
- Phase 4
- 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 47 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Attention deficit hyperactivity disorder DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) diagnosis
- Score above 32 on the Swanson, Nolan, and Pelham-IV scale
- Child is registered in a school or day care center
- Children without the use of stimulants or any psychotropic in the last 30 days
Who cannot join
- Intelligence quotient <70
- The presence of clinical condition or history of neurological disorder or head trauma with conscience loss
- The presence of affective and psychotic disorders, as well as autism spectrum disorders.
- The absence of a legal representative with the capacity to understand the study objectives and the instructions related to its participation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 01060-970
About this study
Official title: Early Interventions in Children With Attention Deficit/Hyperactivity Disorder: Randomized Controlled Trial Comparing Methylphenidate Parental Training in Treating Preschool Children With Attention Deficit / Hyperactivity Disorder
Introduction: Attention deficit/hyperactivity disorder (ADHD) is one of the most prevalent mental disorders in children and is associated with important negative functional outcomes throughout development. The first signs and symptoms become apparent in preschool age. Therefore, early interventions in this population have the potential of limiting the disorder's negative impact and preventing future impairments in affected individuals. The first-choice medication for treating ADHD is methylphenidate, which has evidence of efficacy and safety in preschool children. However, non-evidence based worries and pressure from the media placed parent training as the first-line treatment for ADHD in clinical guidelines. Parent training is a behavioral intervention implemented with the parents, with weekly sessions for 8 weeks, adequate for treating ADHD dysfunctional symptoms and behaviors. However, the level of evidence for this intervention is reduced. Furthermore, the need of trained therapists in the public health system, added to the difficulties on adherence and comprehension from parents, limit its generalization and raise questions regarding its indications. Until now, no study has compared pharmacological treatment with methylphenidate to parent training in preschool children with ADHD regarding their clinical efficacy and cost-effectiveness. Moreover, no study has evaluated the impact of pharmacological intervention and psychotherapy on neurobiological mechanisms of ADHD, which is crucial for determining their impact on neurodevelopment.
Objectives: This is a double-blind randomized clinical trial that aims to evaluate the efficacy, tolerability, and acceptability of treatment with methylphenidate compared to parental training and placebo in preschool children with ADHD.
Read more
Methods: This study will be a randomized, double-blind, parallel-group, evaluating two active interventions and placebo control group. One hundred and fifty children aged 3 years and 11 months and 5 years and 11 months, diagnosed with ADHD, will be randomized to receive treatment with methylphenidate and information (50 children), parental training and treatment with placebo medication (50 children) or belong to active control group with educational information for parents and placebo treatment with no treatment (active control, 50 children). The treatment will last eight weeks, the neurobiological outcomes will be assessed before and after treatment and clinical outcomes will be assessed at weeks 0, 5 and 9. After the end of treatment, all participants will be invited to participate in a 3 years' annual follow-up. 50 children with typical development will also be evaluated in relation to neurobiological measures.
Implications: This study proposes an innovative and relevant analysis, which will enable the field to advance the knowledge of biological mechanisms related to ADHD and to treatment response. Also, the study will expand the evidence to guide early prevention strategies and early intervention.
Read the detailed description
The recruitment of participants will be performed through social media divulgation, on our official website and through contact with preschools in the city of Sao Paulo. The participants that have been selected on the telephonic pre-screening are called for a diagnostic evaluation and an eligibility criteria verification performed by a child and adolescence psychiatrist and neuropsychologists. The psychiatric care and the outcomes evaluation sessions will be conducted by trained professionals, under the principal investigator's supervision.
The children will be randomized using the website randomization.com to one of the three groups: drug treatment with methylphenidate and educational information, parental training and placebo medication, or active control group with educational information and placebo medication. After the eight-week intervention, the participants can receive treatments not previously offered according to a clinical decision.
All selected participants for the clinical trial will be evaluated and accompanied by a child and adolescent psychiatrist before the study and bi-weekly until its completion. Furthermore, a blind evaluator will be responsible for the outcomes measures evaluation.
The clinical evaluator (child and adolescent psychiatrist) and the research assistant responsible for the questionnaires application will be blind towards the modality of treatment that the participant undergoes.
All of the study's evaluation protocol and monitoring is done on the platform Research Electronic Data Capture - REDCap, a software developed by Vanderbilt University - Tennessee, which is hosted in The Clinics Hospital of the University of São Paulo Medical School server. REDCap presents three main functions: a) electronic data collection; b) data management; c) study flow management. This data bank complies with the international policies of data's privacy and security on health area. In addition to the collection and storage structure, validation, auditing and data exporting tools of the system itself are also used.
The efficacy analysis will be made from treatment intention (data from all randomized patients will be included in the analysis). The outcomes (clinical measures of efficacy and tolerability) will be analyzed through mixed effects analyses, with individual models for each outcome. This model assumes that missing data occurs at random and avoids potential biases associated with the analysis only of the individuals who completed the observations or using the strategy to carry the last observation made. The model will include fixed effects for treatment (three levels), time (0, 5 and 9 weeks), time-treatment interaction and randomization effect for the participants. Effect sizes will be calculated by subtracting of the modification of each of the outcomes between the patients in the active groups versus active group control, and between both active treatments, divided by the standard deviation of the entire sample.
- Being tested
- Methylphenidate, Parental training, Psychoeducational groups for parents, Placebo pill
- Keywords
- Parental training, Preschool age, Attention Deficit/Hyperactivity Disorder (ADHD)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Methylphenidate treatment with a initial dosage of 0,3 mg/kg per day (weekly dosage adjustments).
Parental trainingBehavioural
Weekly parental training conducted by behavioral psychologists.
Psychoeducational groups for parentsOther
Weekly psychoeducational groups conducted by educators.
Placebo pillDrug
Placebo pill during 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate-psychoeducational group | Experimental | Methylphenidate treatment with a initial dosage of 0,3 mg/kg per day (weekly dosage adjustments) and weekly psychoeducational groups for parents during 8 weeks. Receives: Drug: Methylphenidate; Other: Psychoeducational groups for parents |
| Parental training-placebo pill | Experimental | Weekly parental training conducted by behavioral psychologists and placebo pill during 8 weeks. Receives: Behavioral: Parental training; Drug: Placebo pill |
| Psychoeducational group-placebo pill | Placebo comparator | Weekly psychoeducational groups for parents and placebo pill during 8 weeks. Receives: Other: Psychoeducational groups for parents; Drug: Placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in attention deficit and hyperactivity symptoms
The child will be assessed with the Swanson, Nolan and Pelham (SNAP) scale.
Measured: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
Change in symptom severity
The child will be assessed by a blinded rater with the Clinical Global Impressions Scale (CGI).
Measured: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
Change in social and psychiatric functioning
The child will be assessed with the Children's Global Assessment Scale (CGAS).
Measured: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
Secondary outcomes (6)
Change in executive functions
The child will be assessed with the Continuous Performance Test (CPT).
Measured: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
Adverse effects of the treatment
The caregiver will be assessed by an adverse effects scale.
Measured: Along 8 weeks.
Evaluate ADHD symptoms that may influence treatment response and adherence
The caregiver will be assessed by Adult ADHD Self-Report Scale (ASRS).
Measured: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
Evaluate Depression symptoms that may influence treatment response and adherence
The caregiver will be assessed with Beck Depression Inventory (BDI-II)
Measured: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
Changes in irritability symptoms
The child will be assessed with the Affective Reactivity Index (ARI) scale.
Measured: Baseline and after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
Changes in disruptive behavior symptoms
The child will be assessed with the Multidimensional Assessment Profile of Disruptive Behavior (MAP-DB)
Measured: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Guilherme Vanoni Polanczyk, MD PhD, University of Sao Paulo
- Investigators
- Guilherme V Polanczyk, Principal investigator, University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807870
- Sponsor's protocol ID
- 466859/2014-7
- Status last verified
- Aug 2020
- First submitted
- 9 Jun 2016
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Farhat LC, Sugaya LS, Bloch MH, Childress A, Cortese S, Fatori D, Salum GA, Rohde LA, Polanczyk GV. Individual Participant Data Meta-Analysis: Moderators of Response to Stimulants for Preschool Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2026 Jun;65(6):781-792. doi: 10.1016/j.jaac.2025.09.012. Epub 2025 Sep 18.
PubMed 40975435Sugaya LS, Salum GA, de Sousa Gurgel W, de Morais EM, Del Prette G, Pilatti CD, Dalmaso BB, Leibenluft E, Rohde LA, Polanczyk GV. Efficacy and safety of methylphenidate and behavioural parent training for children aged 3-5 years with attention-deficit hyperactivity disorder: a randomised, double-blind, placebo-controlled, and sham behavioural parent training-controlled trial. Lancet Child Adolesc Health. 2022 Dec;6(12):845-856. doi: 10.1016/S2352-4642(22)00279-6. Epub 2022 Oct 26.
PubMed 36306807
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Interventions in Children With Attention Deficit/Hyperactivity Disorder: Randomized Controlled Trial Comparing Methylphenidate Parental Training in Treating Preschool Children With Attention Deficit / Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02807870
- Acronym / sponsor ID
- 466859/2014-7
- Keywords
- Parental training, Preschool age, Attention Deficit/Hyperactivity Disorder (ADHD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jun 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 21 Jun 2016 (estimated)
- 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.
Introduction: Attention deficit/hyperactivity disorder (ADHD) is one of the most prevalent mental disorders in children and is associated with important negative functional outcomes throughout development. The first signs and symptoms become apparent in preschool age. Therefore, early interventions in this population have the potential of limiting the disorder's negative impact and preventing future impairments in affected individuals. The first-choice medication for treating ADHD is methylphenidate, which has evidence of efficacy and safety in preschool children. However, non-evidence based worries and pressure from the media placed parent training as the first-line treatment for ADHD in clinical guidelines. Parent training is a behavioral intervention implemented with the parents, with weekly sessions for 8 weeks, adequate for treating ADHD dysfunctional symptoms and behaviors. However, the level of evidence for this intervention is reduced. Furthermore, the need of trained therapists in the public health system, added to the difficulties on adherence and comprehension from parents, limit its generalization and raise questions regarding its indications. Until now, no study has compared pharmacological treatment with methylphenidate to parent training in preschool children with ADHD regarding their clinical efficacy and cost-effectiveness. Moreover, no study has evaluated the impact of pharmacological intervention and psychotherapy on neurobiological mechanisms of ADHD, which is crucial for determining their impact on neurodevelopment.
Objectives: This is a double-blind randomized clinical trial that aims to evaluate the efficacy, tolerability, and acceptability of treatment with methylphenidate compared to parental training and placebo in preschool children with ADHD.
Methods: This study will be a randomized, double-blind, parallel-group, evaluating two active interventions and placebo control group. One hundred and fifty children aged 3 years and 11 months and 5 years and 11 months, diagnosed with ADHD, will be randomized to receive treatment with methylphenidate and information (50 children), parental training and treatment with placebo medication (50 children) or belong to active control group with educational information for parents and placebo treatment with no treatment (active control, 50 children). The treatment will last eight weeks, the neurobiological outcomes will be assessed before and after treatment and clinical outcomes will be assessed at weeks 0, 5 and 9. After the end of treatment, all participants will be invited to participate in a 3 years' annual follow-up. 50 children with typical development will also be evaluated in relation to neurobiological measures.
Implications: This study proposes an innovative and relevant analysis, which will enable the field to advance the knowledge of biological mechanisms related to ADHD and to treatment response. Also, the study will expand the evidence to guide early prevention strategies and early intervention.
Detailed description
The recruitment of participants will be performed through social media divulgation, on our official website and through contact with preschools in the city of Sao Paulo. The participants that have been selected on the telephonic pre-screening are called for a diagnostic evaluation and an eligibility criteria verification performed by a child and adolescence psychiatrist and neuropsychologists. The psychiatric care and the outcomes evaluation sessions will be conducted by trained professionals, under the principal investigator's supervision.
The children will be randomized using the website randomization.com to one of the three groups: drug treatment with methylphenidate and educational information, parental training and placebo medication, or active control group with educational information and placebo medication. After the eight-week intervention, the participants can receive treatments not previously offered according to a clinical decision.
All selected participants for the clinical trial will be evaluated and accompanied by a child and adolescent psychiatrist before the study and bi-weekly until its completion. Furthermore, a blind evaluator will be responsible for the outcomes measures evaluation.
The clinical evaluator (child and adolescent psychiatrist) and the research assistant responsible for the questionnaires application will be blind towards the modality of treatment that the participant undergoes.
All of the study's evaluation protocol and monitoring is done on the platform Research Electronic Data Capture - REDCap, a software developed by Vanderbilt University - Tennessee, which is hosted in The Clinics Hospital of the University of São Paulo Medical School server. REDCap presents three main functions: a) electronic data collection; b) data management; c) study flow management. This data bank complies with the international policies of data's privacy and security on health area. In addition to the collection and storage structure, validation, auditing and data exporting tools of the system itself are also used.
The efficacy analysis will be made from treatment intention (data from all randomized patients will be included in the analysis). The outcomes (clinical measures of efficacy and tolerability) will be analyzed through mixed effects analyses, with individual models for each outcome. This model assumes that missing data occurs at random and avoids potential biases associated with the analysis only of the individuals who completed the observations or using the strategy to carry the last observation made. The model will include fixed effects for treatment (three levels), time (0, 5 and 9 weeks), time-treatment interaction and randomization effect for the participants. Effect sizes will be calculated by subtracting of the modification of each of the outcomes between the patients in the active groups versus active group control, and between both active treatments, divided by the standard deviation of the entire sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate-psychoeducational group | Experimental | Drug: Methylphenidate, Other: Psychoeducational groups for parentsMethylphenidate treatment with a initial dosage of 0,3 mg/kg per day (weekly dosage adjustments) and weekly psychoeducational groups for parents during 8 weeks. |
| Parental training-placebo pill | Experimental | Behavioral: Parental training, Drug: Placebo pillWeekly parental training conducted by behavioral psychologists and placebo pill during 8 weeks. |
| Psychoeducational group-placebo pill | Placebo comparator | Other: Psychoeducational groups for parents, Drug: Placebo pillWeekly psychoeducational groups for parents and placebo pill during 8 weeks. |
Who may qualify
- Ages
- 47 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Attention deficit hyperactivity disorder DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) diagnosis
- Score above 32 on the Swanson, Nolan, and Pelham-IV scale
- Child is registered in a school or day care center
- Children without the use of stimulants or any psychotropic in the last 30 days
Key exclusion criteria (4 listed)
- Intelligence quotient <70
- The presence of clinical condition or history of neurological disorder or head trauma with conscience loss
- The presence of affective and psychotic disorders, as well as autism spectrum disorders.
- The absence of a legal representative with the capacity to understand the study objectives and the instructions related to its participation.
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 |
|---|---|---|
| MethylphenidateMethylphenidate treatment with a initial dosage of 0,3 mg/kg per day (weekly dosage adjustments). | Drug | Methylphenidate-psychoeducational group |
| Parental trainingWeekly parental training conducted by behavioral psychologists. | Behavioural | Parental training-placebo pill |
| Psychoeducational groups for parentsWeekly psychoeducational groups conducted by educators. | Other | Methylphenidate-psychoeducational group, Psychoeducational group-placebo pill |
| Placebo pillPlacebo pill during 8 weeks. | Drug | Parental training-placebo pill, Psychoeducational group-placebo pill |
Primary outcome
Change in attention deficit and hyperactivity symptoms
Time frame: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
The child will be assessed with the Swanson, Nolan and Pelham (SNAP) scale.
Change in symptom severity
Time frame: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
The child will be assessed by a blinded rater with the Clinical Global Impressions Scale (CGI).
Change in social and psychiatric functioning
Time frame: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
The child will be assessed with the Children's Global Assessment Scale (CGAS).
6 secondary outcomes
Change in executive functions
Time frame: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
Adverse effects of the treatment
Time frame: Along 8 weeks.
Evaluate ADHD symptoms that may influence treatment response and adherence
Time frame: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
Evaluate Depression symptoms that may influence treatment response and adherence
Time frame: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
Changes in irritability symptoms
Time frame: Baseline and after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
Changes in disruptive behavior symptoms
Time frame: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention
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 18 Aug 2020.
- Derived from this study: PubMed 40975435Farhat LC, Sugaya LS, Bloch MH, Childress A, Cortese S, Fatori D, Salum GA, Rohde LA, Polanczyk GV. Individual Participant Data Meta-Analysis: Moderators of Response to Stimulants for Preschool Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2026 Jun;65(6):781-792. doi: 10.1016/j.jaac.2025.09.012. Epub 2025 Sep 18.
- Derived from this study: PubMed 36306807Sugaya LS, Salum GA, de Sousa Gurgel W, de Morais EM, Del Prette G, Pilatti CD, Dalmaso BB, Leibenluft E, Rohde LA, Polanczyk GV. Efficacy and safety of methylphenidate and behavioural parent training for children aged 3-5 years with attention-deficit hyperactivity disorder: a randomised, double-blind, placebo-controlled, and sham behavioural parent training-controlled trial. Lancet Child Adolesc Health. 2022 Dec;6(12):845-856. doi: 10.1016/S2352-4642(22)00279-6. Epub 2022 Oct 26.
- 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.
Guilherme V Polanczyk principal investigator
University of Sao Paulo Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate, Parental training and Psychoeducational groups for parents in people with Attention Deficit Disorder With Hyperactivity and Preschool Child, run by University of Sao Paulo at 1 site in Brazil.
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 4 inclusion and 4 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 18 Aug 2020. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 attention deficit and hyperactivity symptoms (time frame: Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention). The study lists 3 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 NCT02807870, which also lists 2 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 18 Aug 2020.