Pediatric CancerNCT05483166
Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The ImPACT Program - A Pilot Study
A study testing ImPACT in people with Pediatric Cancer and Cognitive Dysfunction, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The aim of the present pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for childhood cancer survivors and their families. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Pediatric Cancer, Cognitive Dysfunction
- What is being tested?
- ImPACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2022to 26 Jun 2026
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cancer diagnosis of a leukemia, lymphoma, or central nervous system tumor
- Completed primary treatment at least 6 months ago
- Not terminally ill
- Attend school
- Living with one or more parents who speak Danish and are willing to co-participate
- Screened as having parent-reported cognitive and/or neurobehavioral impairment
Who cannot join
- Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment that might contribute to cognitive or neurobehavioral impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The "I'm Aware: Parents and Children Together" (ImPACT) Program - A Pilot Study
The aim of the present pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for childhood cancer survivors and their families.
Read the detailed description
Cognitive impairment is the most common late effect in childhood cancer survivors, and despite the negative effects of these symptoms on quality of life, scholastic achievement and long-term socioeconomic outcomes, there continues to be no "gold standard" treatment for childhood cancer survivors with cognitive impairment.
Indeed, there is a dearth of research on interventions to treat cognitive impairment in childhood cancer survivors, and the relatively few studied interventions have proven limited effects. Arguably, four key elements are missing from a majority of studied interventions:1) transfer of learning to real-world functional outcomes, 2) awareness training to enhance compensatory strategy use, 3) inclusion of parents that could enhance transfer of learning to the home, and 4) recognition of the inter-related nature of cognitive, neurobehavioral, and psychological functions.
The "I'M aware: Parents and Children Together (ImPACT)" program is a novel, context-sensitive neuropsychological rehabilitation intervention that targets the above mentioned missing elements in previous rehabilitation efforts. The present pilot study aims to assess the feasibility, acceptability, and preliminary efficacy of this program in childhood cancer survivors with cognitive impairment in preparation for a large-scale randomized controlled trial.
- Conditions
- Pediatric Cancer, Cognitive Dysfunction
- Being tested
- ImPACT
- Keywords
- Pediatric Cancer, Cognitive Dysfunction, Neuropsychological Rehabilitation, Neurobehavioral Impairment
- Medical subject headings
- Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImPACTBehavioural
During the ImPACT program, the childhood cancer survivor and at least one parent collaborates on:
- Becoming aware of the child's core strengths and difficulties
- Helping the child to be optimally responsive to the guidance of the parent(s), and
- Creating compensatory strategies to respond to real-world manifestations of the child's difficulties and helping the child implement these strategies at home.
| Study group | Role | What they receive |
|---|---|---|
| ImPACT program | Experimental | The ImPACT program consists of 8 weekly 1-hour sessions with homework between sessions. Receives: Behavioral: ImPACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent-reported neurobehavioral functioning
The parent-report screening version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 12 items: answer format range: 1-3; total score range: 12-36. Higher score indicates more impairment.
Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent-reported cognitive functioning
The parent-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.
Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Secondary outcomes (26)
Parent-reported neurobehavioral functioning
The parent-report version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 63 items: answer format range: 1-3; total score range: 63-189. Higher score indicates more impairment.
Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-reported cognitive functioning
The parent-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.
Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported neurobehavioral functioning
The child-report version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 55 items: answer format range: 1-3; total score range: 55-165. Higher score indicates more impairment.
Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Child-reported neurobehavioral functioning
The child-report version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 55 items: answer format range: 1-3; total score range: 55-165. Higher score indicates more impairment.
Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported cognitive functioning
The child-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.
Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Child-reported cognitive functioning
The child-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.
Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-reported pediatric quality of life
The parent-report version of the Pediatric Quality of Life (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate more impairment.
Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent-reported pediatric quality of life
The parent-report version of the Pediatric Quality of Life Inventory (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate lower quality of life.
Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported pediatric quality of life
The child-report version of the Pediatric Quality of Life (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate more impairment.
Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Child-reported pediatric quality of life
The child-report version of the Pediatric Quality of Life (PedsQL) Core and Cancer scale. 23 items for the Core Scale, 25 items for the Cancer Scale: answer format range: 0-4; total score range: 0-100 (both scales). Lower scores indicate more impairment.
Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-reported pediatric anxiety and depression
The parent-report version of the Revised Children's Anxiety and Depression Scale (CADS) Short Form. 47 items: answer format range: 0-3; total score range: 0-27 (social phobia and panic disorder subscales), 0-30 (major depressive disorder subscale), 0-21 (social anxiety disorder subscale), 0-18 (generalized anxiety disorder and obsessive compulsive disorder subscales). Higher scores indicate more anxiety and depression.
Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent-reported pediatric anxiety and depression
The parent-report version of the Revised Children's Anxiety and Depression Scale (CADS) Short Form. 47 items: answer format range: 0-3; total score range: 0-27 (social phobia and panic disorder subscales), 0-30 (major depressive disorder subscale), 0-21 (social anxiety disorder subscale), 0-18 (generalized anxiety disorder and obsessive compulsive disorder subscales). Higher scores indicate more anxiety and depression.
Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported pediatric anxiety and depression
The child-report version of the Revised Children's Anxiety and Depression Scale (CADS) Short Form. 47 items: answer format range: 0-3; total score range: 0-27 (social phobia and panic disorder subscales), 0-30 (major depressive disorder subscale), 0-21 (social anxiety disorder subscale), 0-18 (generalized anxiety disorder and obsessive compulsive disorder subscales). Higher scores indicate more anxiety and depression.
Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Child-reported pediatric anxiety and depression
The child-report version of the Revised Children's Anxiety and Depression Scale (CADS) Short Form. 47 items: answer format range: 0-3; total score range: 0-27 (social phobia and panic disorder subscales), 0-30 (major depressive disorder subscale), 0-21 (social anxiety disorder subscale), 0-18 (generalized anxiety disorder and obsessive compulsive disorder subscales). Higher scores indicate more anxiety and depression.
Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-reported pediatric fatigue
The parent-report version of the Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS). 18 items: answer format range 0-4; total score range: 0-100. Lower score indicates more fatigue.
Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent-reported pediatric fatigue
The parent-report version of the Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS). 18 items: answer format range 0-4; total score range: 0-100. Lower score indicates more fatigue.
Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported pediatric fatigue
The child-report version of the Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS). 18 items: answer format range 0-4; total score range: 0-100. Lower score indicates more fatigue.
Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Child-reported pediatric fatigue
The child-report version of the Pediatric Quality of Life - Multidimensional Fatigue Scale (PedsQL-MFS). 18 items: answer format range 0-4; total score range: 0-100. Lower score indicates more fatigue.
Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent sense of competence
The Parenting Sense of Competence Scale (PSC scale).17 items: answer format range 1-6; total score range: 16-102. Higher score indicates more competence.
Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent sense of competence
The Parenting Sense of Competence Scale (PSC scale). 17 items: answer format range 1-6; total score range: 16-102. Higher score indicates more competence.
Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-reported participant motivation
The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation.
Measured: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
Child-reported participant motivation
The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation.
Measured: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3))
Parent-reported participant satisfaction
The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.
Measured: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
Child-reported participant satisfaction
The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction.
Measured: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
Objective cognitive functioning (Child only)
Standard neuropsychological test battery. Different scoring formats.
Measured: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Objective cognitive functioning (Child only)
Standard neuropsychological test battery. Different scoring formats.
Measured: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Oct 2022
- Primary completion26 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Lisa Maria Wu, University of Aarhus
- Investigators
- Lisa M Wu, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483166
- Sponsor's protocol ID
- ImPACT Child
- Status last verified
- Jan 2024
- First submitted
- 19 Jul 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Parents in Neuropsychological Rehabilitation for Childhood Cancer Survivors: The "I'm Aware: Parents and Children Together" (ImPACT) Program - A Pilot Study
- ClinicalTrials.gov ID
- NCT05483166
- Acronym / sponsor ID
- ImPACT Child
- Conditions
- Pediatric Cancer, Cognitive Dysfunction
- Keywords
- Pediatric Cancer, Cognitive Dysfunction, Neuropsychological Rehabilitation, Neurobehavioral Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 1 Aug 2022 (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 aim of the present pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for childhood cancer survivors and their families.
Detailed description
Cognitive impairment is the most common late effect in childhood cancer survivors, and despite the negative effects of these symptoms on quality of life, scholastic achievement and long-term socioeconomic outcomes, there continues to be no "gold standard" treatment for childhood cancer survivors with cognitive impairment.
Indeed, there is a dearth of research on interventions to treat cognitive impairment in childhood cancer survivors, and the relatively few studied interventions have proven limited effects. Arguably, four key elements are missing from a majority of studied interventions:1) transfer of learning to real-world functional outcomes, 2) awareness training to enhance compensatory strategy use, 3) inclusion of parents that could enhance transfer of learning to the home, and 4) recognition of the inter-related nature of cognitive, neurobehavioral, and psychological functions.
The "I'M aware: Parents and Children Together (ImPACT)" program is a novel, context-sensitive neuropsychological rehabilitation intervention that targets the above mentioned missing elements in previous rehabilitation efforts. The present pilot study aims to assess the feasibility, acceptability, and preliminary efficacy of this program in childhood cancer survivors with cognitive impairment in preparation for a large-scale randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ImPACT program | Experimental | Behavioral: ImPACTThe ImPACT program consists of 8 weekly 1-hour sessions with homework between sessions. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Cancer diagnosis of a leukemia, lymphoma, or central nervous system tumor
- Completed primary treatment at least 6 months ago
- Not terminally ill
- Attend school
- Living with one or more parents who speak Danish and are willing to co-participate
Key exclusion criteria (1 listed)
- Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment that might contribute to cognitive or neurobehavioral impairment
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 |
|---|---|---|
| ImPACTDuring the ImPACT program, the childhood cancer survivor and at least one parent collaborates on: 1. Becoming aware of the child's core strengths and difficulties 2. Helping the child to be optimally responsive to the guidance of the parent(s), and 3. Creating compensatory strategies to respond to real-world manifestations of the child's difficulties and helping the child implement these strategies at home. | Behavioural | ImPACT program |
Primary outcome
Parent-reported neurobehavioral functioning
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
The parent-report screening version of the Behavior Rating Inventory of Executive Function 2nd Edition (BRIEF-2). 12 items: answer format range: 1-3; total score range: 12-36. Higher score indicates more impairment.
Parent-reported cognitive functioning
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
The parent-report version of the Pediatric Perceived Cognitive Function (PedsPCF) Short Form. 7 items: answer format range 1-5; total score range: 7-35. Lower score indicates more impairment.
26 secondary outcomes
Parent-reported neurobehavioral functioning
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-reported cognitive functioning
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported neurobehavioral functioning
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Child-reported neurobehavioral functioning
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported cognitive functioning
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Child-reported cognitive functioning
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-reported pediatric quality of life
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent-reported pediatric quality of life
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported pediatric quality of life
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Child-reported pediatric quality of life
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-reported pediatric anxiety and depression
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent-reported pediatric anxiety and depression
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported pediatric anxiety and depression
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Child-reported pediatric anxiety and depression
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-reported pediatric fatigue
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent-reported pediatric fatigue
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Child-reported pediatric fatigue
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Child-reported pediatric fatigue
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent sense of competence
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Parent sense of competence
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
Parent-reported participant motivation
Time frame: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
Child-reported participant motivation
Time frame: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3))
Parent-reported participant satisfaction
Time frame: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
Child-reported participant satisfaction
Time frame: After last session (approximately 9 weeks after Baseline assessment (T1): Post-intervention, T3)
Objective cognitive functioning (Child only)
Time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)
Objective cognitive functioning (Child only)
Time frame: Baseline (T1) to 9 week after post-intervention (approximately 18 weeks later: Follow-up, T4)
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 29 Oct 2026.
- 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.
Lisa M Wu, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ImPACT in people with Pediatric Cancer and Cognitive Dysfunction, run by Aarhus University Hospital at 1 site in Denmark.
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 6 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 29 Oct 2026. 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 Denmark. 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?
Parent-reported neurobehavioral functioning (time frame: Baseline (T1) to after last session (approximately 9 weeks later: Post-intervention, T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.