Childhood LeukemiaSTEP-LeukemiaNCT07587411
Stepped-Care Support for Children With Leukaemia
A study testing Step Care Intervention in people with Childhood Leukemia, run by Zhengzhou University at 1 site in Pakistan.
Trial summary
This study aims to develop, culturally adapt, and pilot test a stepped-care psychosocial intervention designed to improve emotional and behavioral health among children with leukemia in Pakistan. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Childhood Leukemia
- What is being tested?
- Step Care Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with leukaemia (confirmed by medical records).
- Aged between 7 and 14 years at the time of diagnosis.
- Primary carers (parents, guardians, or immediate family members) who are directly involved in the child's care and treatment.
- Ability to comprehend and communicate in the local language (e.g., Urdu, Pashto).
- Child in the stable remission or maintenance phase of leukaemia treatment.
- Willingness to participate in the study and provide informed consent (child assent and parental consent).
Who cannot join
- Acute medical instability requiring intensive care.
- Cognitive impairment preventing meaningful participation.
- Severe mental health conditions (e.g., active psychosis, extreme depression) in the child.
- Non-primary carers without direct responsibility for the child's care.
- Active substance abuse or impairing conditions in the primary carer.
- Non-English/non-Urdu/Pashto-speaking participants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Hayatabad Medical Complex
Peshawar, Khyber Pukhtoon Khwa, 25000
About this study
Official title: Developing a Stepped-Care Intervention for Emotional and Behavioral Health in Children With Leukemia: A Study Protocol
This study aims to develop, culturally adapt, and pilot test a stepped-care psychosocial intervention designed to improve emotional and behavioral health among children with leukemia in Pakistan. Children with leukemia may experience anxiety, depressive symptoms, irritability, sleep disturbance, social withdrawal, treatment-related distress, and behavioral difficulties during the cancer treatment pathway. In resource-constrained settings, structured psychosocial care is often limited or unavailable within routine pediatric oncology services. This study addresses this gap by developing a feasible, culturally responsive, and theory-informed intervention that can be delivered within existing clinical resources.
The study follows a multi-stage intervention-development process guided by the Intervention Mapping framework and Medical Research Council guidance for complex interventions. The stages include: evidence review and expert consultation to identify gaps in current psychosocial care; mixed-methods needs assessment with children, caregivers, and healthcare professionals; refinement of the intervention through focus groups and an e-Delphi process; and pilot testing of the intervention in a two-arm pilot randomized controlled trial.
Read more
The pilot trial will include children aged 7 to 14 years with leukemia who are clinically stable and in the remission or maintenance phase of treatment, together with their primary caregivers. Participants will be allocated to either the stepped-care intervention plus routine care or routine care alone. The stepped-care program is delivered over 12 weeks and progresses from low-intensity universal support to more intensive individualized care according to child and family needs. Intervention components include an information booklet, psychoeducational video, face-to-face psychoeducation, peer support, cognitive behavioral strategies, parent-child behavioral training, and one-to-one therapy or referral when indicated. The intervention will be delivered by trained mental health nurses under supervision of a psychologist.
The primary focus of this pilot trial is feasibility and acceptability, including recruitment, retention, attendance, intervention fidelity, completion of outcome measures, and participant satisfaction. Secondary exploratory outcomes include emotional and behavioral functioning, distress, quality of life, depressive symptoms, sleep disturbance, treatment adherence, and family functioning. Findings will guide refinement of the intervention and inform the design of a future fully powered randomized controlled trial.
Read the detailed description
This study will develop, culturally adapt, and pilot evaluate a stepped-care psychosocial intervention to support emotional and behavioural health among children with leukaemia in Pakistan. Children undergoing treatment for leukaemia may experience anxiety, low mood, procedural fear, irritability, sleep disturbance, social withdrawal, school disruption, reduced quality of life, and difficulties with treatment routines. These challenges may also interact with caregiver distress and family functioning. In Pakistan and similar resource-constrained settings, paediatric oncology care is primarily focused on diagnosis, chemotherapy, and medical follow-up, while structured psychosocial screening and evidence-based psychological support are not routinely integrated into care. A culturally adapted stepped-care model may provide a practical approach by offering low-intensity support to all families and reserving more intensive psychosocial input for children and caregivers with greater or persistent needs.
The study is guided by Intervention Mapping and the Medical Research Council guidance for developing and evaluating complex interventions. A sequential, stage-based design will be used, with findings from each stage informing the next stage. The intervention-development process will include evidence synthesis, stakeholder consultation, mixed-methods needs assessment, intervention refinement, and pilot evaluation.
In the first stage, a scoping review and expert consultation will be conducted to identify existing evidence, contextual gaps, feasible intervention components, and implementation considerations relevant to paediatric oncology settings in Pakistan. In the second stage, a mixed-methods needs assessment will explore the emotional, behavioural, family, and service-related needs of children with leukaemia and their caregivers, as well as professional perspectives on feasible psychosocial care delivery. In the third stage, the draft intervention will be refined through feedback from children, caregivers, and multidisciplinary experts, including focus groups and a structured e-Delphi process. This stage will focus on cultural appropriateness, developmental suitability, session burden, delivery format, safety procedures, and stepped-care decision rules.
The final stage will pilot and evaluate the 12-week stepped-care intervention in comparison with routine care. The pilot evaluation is intended to assess feasibility, acceptability, implementation procedures, intervention fidelity, safety, and the suitability of outcome assessment procedures. It is not designed to establish definitive intervention effectiveness. Findings will be used to refine the intervention manual, delivery procedures, and future trial methods.
The stepped-care intervention is designed as a manualised psychosocial programme delivered by trained mental health nurses under psychologist supervision. The intervention includes universal psychoeducation for all participating families, followed by progressively more intensive components according to the child's and caregiver's level of need. Lower-intensity components include an information booklet, psychoeducational video, and face-to-face psychoeducation. Children and families with emerging or persistent psychosocial concerns may receive peer support, cognitive behavioural strategies, parent-child behavioural training, or one-to-one therapeutic support with referral to specialist services when clinically indicated.
The intervention is informed by the stepped-care model, cognitive behavioural theory, stress and coping theory, resilience theory, family systems theory, the social ecological model, and self-regulation theory. Together, these frameworks support the development of an intervention that addresses illness-related appraisal, coping skills, emotional regulation, family communication, social support, behavioural adjustment, and appropriate escalation of care.
Fidelity will be supported through a structured intervention manual, facilitator training, session checklists, intervention logs, and supervision meetings. Safety procedures will be used to identify and refer participants requiring urgent psychological or psychiatric care. Quantitative and qualitative findings from the pilot evaluation will be integrated to determine whether the intervention is feasible, acceptable, culturally appropriate, and suitable for refinement before a future fully powered randomized controlled trial.
- Conditions
- Childhood Leukemia
- Being tested
- Step Care Intervention
- Keywords
- Stepped care, leukemia, child emotional behavioral health
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step Care InterventionBehavioural
Participants will receive a 12-week stepped-care psychosocial intervention including psychoeducation, peer support, CBT sessions, parent-child training, and individualized therapy along with routine care
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Step Care Intervention Participants will receive a 12-week stepped-care psychosocial intervention including psychoeducation, peer support, CBT sessions, parent-child training, and individualised therapy along with routine care. Receives: Behavioral: Step Care Intervention |
| Control Group | No intervention | Routine Care and Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Strengths and Difficulties Questionnaire Total Difficulties Score From Baseline to 12 Weeks
Child emotional and behavioural difficulties will be assessed using the Strengths and Difficulties Questionnaire total difficulties score. The total difficulties score is calculated from the emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems subscales. Scores range from 0 to 40. Higher scores indicate greater emotional and behavioural difficulties. Unit of Measure:
Score on a scale
Score Range:
0 to 40
Direction:
Higher scores indicate greater emotional and behavioural difficulties.
Measured: Baseline and 12 weeks
Change in Paediatric Quality of Life Inventory Total Score From Baseline to 12 Weeks
Child health-related quality of life will be assessed using the Paediatric Quality of Life Inventory. Scores are transformed to a 0-100 scale. Higher scores indicate better health-related quality of life. Unit of Measure:
Score on a scale
Score Range:
0 to 100
Direction:
Higher scores indicate better health-related quality of life.
Measured: Baseline and 12 weeks
Change in Patient Health Questionnaire-9 Total Score From Baseline to 12 Weeks
Caregiver depressive symptoms will be assessed using the Patient Health Questionnaire-9. The PHQ-9 total score ranges from 0 to 27. Higher scores indicate greater severity of depressive symptoms. Unit of Measure:
Score on a scale
Score Range:
0 to 27
Direction:
Higher scores indicate greater depressive symptom severity
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Change in Pediatric/Procedural Anxiety Distress Thermometer Score From Baseline to 12 Weeks
Child procedural anxiety and distress will be assessed using the Paediatric/Procedural Anxiety Distress Thermometer. The score ranges from 0 to 10, with higher scores indicating greater anxiety or distress. Paediatric distress thermometer ratings commonly use a 0 to 10 scale, where 0 indicates no distress and 10 indicates high or extreme distress. Unit of Measure:
Score on a scale
Score Range:
0 to 10
Direction:
Higher scores indicate greater anxiety or distress.
Measured: Baseline and 12 weeks
Change in Sleep Disturbance Scale for Children Total Score From Baseline to 12 Weeks
Child sleep disturbance will be assessed using the Sleep Disturbance Scale for Children. The scale includes 26 items rated on a 5-point Likert scale. The total score ranges from 26 to 130, with higher scores indicating greater sleep disturbance. Unit of Measure:
Score on a scale
Score Range:
26 to 130
Direction:
Higher scores indicate greater sleep disturbance.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start10 Jun 2025
- Primary completion30 Mar 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood LeukemiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will use a two-arm, parallel-group pilot randomized controlled trial model to evaluate a culturally adapted stepped-care psychosocial intervention for children with leukemia in Pakistan. Eligible child-caregiver dyads will be allocated to either the intervention group, receiving the stepped-care program plus routine pediatric oncology care, or the control group, receiving routine care only. The 12-week intervention progresses from low-intensity universal support to higher-intensity individualized care according to the child's emotional and behavioral needs. Intervention components include an information booklet, psychoeducational video, face-to-face psychoeducation, peer support, cognitive behavioral strategies, parent-child behavioral training, and one-to-one therapy or referral when required. The model will assess feasibility, acceptability, fidelity, and preliminary emotional and behavioral outcomes to inform a future full-scale trial.
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fath Ur Rahman, Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587411
- Sponsor's protocol ID
- LeukemiaProtocol_2026_001
- Other IDs
- ZZUIRB2025-03
- Acronym
- STEP-Leukemia
- Status last verified
- May 2026
- First submitted
- 16 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be subject to institutional ethics approval, participant confidentiality requirements, and a signed data-sharing agreement. No personally identifiable information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Stepped-Care Intervention for Emotional and Behavioral Health in Children With Leukemia: A Study Protocol
- ClinicalTrials.gov ID
- NCT07587411
- Acronym / sponsor ID
- STEP-Leukemia / LeukemiaProtocol_2026_001
- Conditions
- Childhood Leukemia
- Keywords
- Stepped care, leukemia, child emotional behavioral health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 May 2026 (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.
This study aims to develop, culturally adapt, and pilot test a stepped-care psychosocial intervention designed to improve emotional and behavioral health among children with leukemia in Pakistan. Children with leukemia may experience anxiety, depressive symptoms, irritability, sleep disturbance, social withdrawal, treatment-related distress, and behavioral difficulties during the cancer treatment pathway. In resource-constrained settings, structured psychosocial care is often limited or unavailable within routine pediatric oncology services. This study addresses this gap by developing a feasible, culturally responsive, and theory-informed intervention that can be delivered within existing clinical resources.
The study follows a multi-stage intervention-development process guided by the Intervention Mapping framework and Medical Research Council guidance for complex interventions. The stages include: evidence review and expert consultation to identify gaps in current psychosocial care; mixed-methods needs assessment with children, caregivers, and healthcare professionals; refinement of the intervention through focus groups and an e-Delphi process; and pilot testing of the intervention in a two-arm pilot randomized controlled trial.
The pilot trial will include children aged 7 to 14 years with leukemia who are clinically stable and in the remission or maintenance phase of treatment, together with their primary caregivers. Participants will be allocated to either the stepped-care intervention plus routine care or routine care alone. The stepped-care program is delivered over 12 weeks and progresses from low-intensity universal support to more intensive individualized care according to child and family needs. Intervention components include an information booklet, psychoeducational video, face-to-face psychoeducation, peer support, cognitive behavioral strategies, parent-child behavioral training, and one-to-one therapy or referral when indicated. The intervention will be delivered by trained mental health nurses under supervision of a psychologist.
The primary focus of this pilot trial is feasibility and acceptability, including recruitment, retention, attendance, intervention fidelity, completion of outcome measures, and participant satisfaction. Secondary exploratory outcomes include emotional and behavioral functioning, distress, quality of life, depressive symptoms, sleep disturbance, treatment adherence, and family functioning. Findings will guide refinement of the intervention and inform the design of a future fully powered randomized controlled trial.
Detailed description
This study will develop, culturally adapt, and pilot evaluate a stepped-care psychosocial intervention to support emotional and behavioural health among children with leukaemia in Pakistan. Children undergoing treatment for leukaemia may experience anxiety, low mood, procedural fear, irritability, sleep disturbance, social withdrawal, school disruption, reduced quality of life, and difficulties with treatment routines. These challenges may also interact with caregiver distress and family functioning. In Pakistan and similar resource-constrained settings, paediatric oncology care is primarily focused on diagnosis, chemotherapy, and medical follow-up, while structured psychosocial screening and evidence-based psychological support are not routinely integrated into care. A culturally adapted stepped-care model may provide a practical approach by offering low-intensity support to all families and reserving more intensive psychosocial input for children and caregivers with greater or persistent needs.
The study is guided by Intervention Mapping and the Medical Research Council guidance for developing and evaluating complex interventions. A sequential, stage-based design will be used, with findings from each stage informing the next stage. The intervention-development process will include evidence synthesis, stakeholder consultation, mixed-methods needs assessment, intervention refinement, and pilot evaluation.
In the first stage, a scoping review and expert consultation will be conducted to identify existing evidence, contextual gaps, feasible intervention components, and implementation considerations relevant to paediatric oncology settings in Pakistan. In the second stage, a mixed-methods needs assessment will explore the emotional, behavioural, family, and service-related needs of children with leukaemia and their caregivers, as well as professional perspectives on feasible psychosocial care delivery. In the third stage, the draft intervention will be refined through feedback from children, caregivers, and multidisciplinary experts, including focus groups and a structured e-Delphi process. This stage will focus on cultural appropriateness, developmental suitability, session burden, delivery format, safety procedures, and stepped-care decision rules.
The final stage will pilot and evaluate the 12-week stepped-care intervention in comparison with routine care. The pilot evaluation is intended to assess feasibility, acceptability, implementation procedures, intervention fidelity, safety, and the suitability of outcome assessment procedures. It is not designed to establish definitive intervention effectiveness. Findings will be used to refine the intervention manual, delivery procedures, and future trial methods.
The stepped-care intervention is designed as a manualised psychosocial programme delivered by trained mental health nurses under psychologist supervision. The intervention includes universal psychoeducation for all participating families, followed by progressively more intensive components according to the child's and caregiver's level of need. Lower-intensity components include an information booklet, psychoeducational video, and face-to-face psychoeducation. Children and families with emerging or persistent psychosocial concerns may receive peer support, cognitive behavioural strategies, parent-child behavioural training, or one-to-one therapeutic support with referral to specialist services when clinically indicated.
The intervention is informed by the stepped-care model, cognitive behavioural theory, stress and coping theory, resilience theory, family systems theory, the social ecological model, and self-regulation theory. Together, these frameworks support the development of an intervention that addresses illness-related appraisal, coping skills, emotional regulation, family communication, social support, behavioural adjustment, and appropriate escalation of care.
Fidelity will be supported through a structured intervention manual, facilitator training, session checklists, intervention logs, and supervision meetings. Safety procedures will be used to identify and refer participants requiring urgent psychological or psychiatric care. Quantitative and qualitative findings from the pilot evaluation will be integrated to determine whether the intervention is feasible, acceptable, culturally appropriate, and suitable for refinement before a future fully powered randomized controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will use a two-arm, parallel-group pilot randomized controlled trial model to evaluate a culturally adapted stepped-care psychosocial intervention for children with leukemia in Pakistan. Eligible child-caregiver dyads will be allocated to either the intervention group, receiving the stepped-care program plus routine pediatric oncology care, or the control group, receiving routine care only. The 12-week intervention progresses from low-intensity universal support to higher-intensity individualized care according to the child's emotional and behavioral needs. Intervention components include an information booklet, psychoeducational video, face-to-face psychoeducation, peer support, cognitive behavioral strategies, parent-child behavioral training, and one-to-one therapy or referral when required. The model will assess feasibility, acceptability, fidelity, and preliminary emotional and behavioral outcomes to inform a future full-scale trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Step Care InterventionStep Care Intervention Participants will receive a 12-week stepped-care psychosocial intervention including psychoeducation, peer support, CBT sessions, parent-child training, and individualised therapy along with routine care. |
| Control Group | No intervention | –Routine Care and Treatment |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children diagnosed with leukaemia (confirmed by medical records).
- Aged between 7 and 14 years at the time of diagnosis.
- Primary carers (parents, guardians, or immediate family members) who are directly involved in the child's care and treatment.
- Ability to comprehend and communicate in the local language (e.g., Urdu, Pashto).
- Child in the stable remission or maintenance phase of leukaemia treatment.
Key exclusion criteria (6 listed)
- Acute medical instability requiring intensive care.
- Cognitive impairment preventing meaningful participation.
- Severe mental health conditions (e.g., active psychosis, extreme depression) in the child.
- Non-primary carers without direct responsibility for the child's care.
- Active substance abuse or impairing conditions in the primary carer.
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 |
|---|---|---|
| Step Care InterventionParticipants will receive a 12-week stepped-care psychosocial intervention including psychoeducation, peer support, CBT sessions, parent-child training, and individualized therapy along with routine care | Behavioural | Intervention Group |
Primary outcome
Change in Strengths and Difficulties Questionnaire Total Difficulties Score From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
Child emotional and behavioural difficulties will be assessed using the Strengths and Difficulties Questionnaire total difficulties score. The total difficulties score is calculated from the emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems subscales. Scores range from 0 to 40. Higher scores indicate greater emotional and behavioural difficulties. Unit of Measure: Score on a scale Score Range: 0 to 40 Direction: Higher scores indicate greater emotional and behavioural difficulties.
Change in Paediatric Quality of Life Inventory Total Score From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
Child health-related quality of life will be assessed using the Paediatric Quality of Life Inventory. Scores are transformed to a 0-100 scale. Higher scores indicate better health-related quality of life. Unit of Measure: Score on a scale Score Range: 0 to 100 Direction: Higher scores indicate better health-related quality of life.
Change in Patient Health Questionnaire-9 Total Score From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
Caregiver depressive symptoms will be assessed using the Patient Health Questionnaire-9. The PHQ-9 total score ranges from 0 to 27. Higher scores indicate greater severity of depressive symptoms. Unit of Measure: Score on a scale Score Range: 0 to 27 Direction: Higher scores indicate greater depressive symptom severity
2 secondary outcomes
Change in Pediatric/Procedural Anxiety Distress Thermometer Score From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
Change in Sleep Disturbance Scale for Children Total Score From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. Data sharing will be subject to institutional ethics approval, participant confidentiality requirements, and a signed data-sharing agreement. No personally identifiable information will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step Care Intervention in people with Childhood Leukemia, run by Zhengzhou University at 1 site in Pakistan.
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 6 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: enrolling by invitation, as of the sponsor's last update on 18 May 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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 Strengths and Difficulties Questionnaire Total Difficulties Score From Baseline to 12 Weeks (time frame: Baseline and 12 weeks). 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?
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 May 2026; AzTrials last refreshed its copy on 2 Nov 2026.