Emotional DistressNCT05639465
Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children
A study testing JoH-C19 and Switch off Get Active in people with Emotional Distress and Prosocial Behavior, run by University of Illinois at Urbana-Champaign at 9 sites in United States.
Trial summary
Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported… Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Distress, Prosocial Behavior, Pandemic, COVID-19
- What is being tested?
- JoH-C19 and Switch off Get Active
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 9 sitesUnited States
- Study dates
- 15 Nov 2022to 15 May 2027
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child experienced the COVID-19 pandemic and an additional large-scale disaster
- child score is 5 or above on the Strengths and Difficulties Questionnaire
- child is in 3- 8th grade at enrollment
- the parent or guardian must complete informed consent and child assent
- child must speak English or Spanish.
Who cannot join
- child is currently receiving treatment for a diagnosed mental health condition
- children who are not able to interact with other students in a group work format, regardless of IEP status
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 5 recruiting
- Recruiting
Boys and Girls Club of Manatee County
Bradenton, Florida, 34207
Tara Powell, PhD, 2173000917, tlpowell@illinois.edu
- Recruiting
Dickinson Independent School District
Dickinson, Texas, 77539
Tara Powell, PhD, 2173000917, tlpowell@illinois.edu
- Active, not recruiting
CARE Connections
Houston, Texas, 77002
- Recruiting
Communities in Schools of Galveston County
La Marque, Texas, 77568
Tara Powell, PhD, 2173000917, tlpowell@illinois.edu
- Active, not recruiting
Coalition for Compassionate Schools
New Orleans, Louisiana, 70118
- Recruiting
Communities in Schools Gulf South
New Orleans, Louisiana, 70179
Tara Powell, PhD, 2173000917, tlpowell@illinois.edu
- Active, not recruiting
Bay District Schools
Panama City, Florida, 32401
- Recruiting
R'Club Child Care, Inc.
St. Petersburg, Florida, 33709
Tara Powell, PhD, 1 217 300 0917, tlpowell@illinois.edu
- Active, not recruiting
Communities in Schools Palm Beach
West Palm Beach, Florida, 33406
About this study
Official title: Pragmatic RCT of a Multi-level Mechanistically Informed Community Intervention to Prevent the Onset of Behavioral Health Symptoms Among Socioeconomically Disadvantaged Pandemic Affected Children
Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported prevention interventions are needed to prevent the onset of mental and behavioral health issues among these children. Building on our preliminary findings, the proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing behavioral health and interpersonal problems among racial and ethnic minority children who live in low-resource high poverty communities.
Read the detailed description
The COVID-19 pandemic is having a profound impact on children globally, jeopardizing their sense of safety, security, and behavioral health. In addition to COVID-19, millions of children are still recovering from recent hurricanes that struck the southern the United States. Children exposed to climate-induced disasters (e.g. hurricanes) are at a significant risk for mental and behavioral health challenges. Coupled with an enduring pandemic, many of these children are disproportionately at risk for escalating mental health problems. Racial and ethnic minority children who live in socioeconomically disadvantaged neighborhoods are among the most vulnerable during and after large-scale disasters. They are more likely experience high levels of social and material losses, displacement, and lack of access to mental and physical health services. Thus, there is a critical need for these children to received accessible, empirically supported preventative interventions to mitigate the onset of mental illness and behavioral health issues. Most post-disaster behavioral health interventions are designed to treat rather than prevent mental health conditions and are often inaccessible to racial and ethnic minority children living in socioeconomically disadvantaged communities. The present study, therefore, seeks to examine the implementation and efficacy of the COVID-19 adaptation of a disaster focused empirically supported prevention intervention, the Journey of Hope (JoH), distributed by Save the Children, a humanitarian organization serving socioeconomically disadvantaged and racial and ethnic minority children in communities dually impacted by COVID-19 and recent hurricanes that struck the Southern United States. The long-term goals of this study are to: (1) respond to the critical need of accessible behavioral health interventions designed to prevent and/or reduce COVID-19 related distress; and (2) provide an understanding on how a COVID-19 tailored prevention intervention mitigates behavioral health disparities among racial and ethnic minority children in high poverty settings who have been exposed to multiple large scale disasters. In a pragmatic randomized control trial with 800 children between 3-8th grade, we seek to: Aim 1: Evaluate the efficacy of the COVID-19 adapted JoH (JoH-C19) in preventing behavioral health and interpersonal problems among socioeconomically disadvantaged and racial and ethnic minority children who have been exposed to multiple large-scale disasters relative to a healthy life-style attention control condition. Aim 2: Examine if hypothesized mechanisms of change variables (social connectedness, adaptive coping, self-efficacy) mediate intervention effects (JoH-C19 vs attention control) on child individual behavioral health and interpersonal outcomes. Aim 3: Assess the moderating impact of COVID-19 related stressors on behavioral health outcomes among children who participate in JoH-C19 versus the control condition. Aim 4: Explore implementation barriers, facilitators, and acceptability of the JoH-C19 within school and after-school settings and delivered by community and school-based counselors.
- Being tested
- JoH-C19, Switch off Get Active
- Medical subject headings
- Altruism, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JoH-C19Behavioural
Journey of Hope- COVID 19 (JoH-C19) includes eight, 1-hour consecutive sessions delivered in groups of 8 children during the school day and in after school settings. The 1.5 hour JoH-C19 caregiver workshop is delivered with groups of 8 parents prior to the child JoH-C19 curriculum
Switch off Get ActiveBehavioural
Switch off Get Active covers 4 topics, and its eight, 1- hour sessions are delivered in groups of 8 children. The 1.5 hour Switch Off Get Active caregiver workshop is delivered with groups of 8 parents prior to the Switch off Get Active child curriculum
| Study group | Role | What they receive |
|---|---|---|
| JoH-C19 | Experimental | After initial randomization, some participants will be assigned to receive JoH-C19 Receives: Behavioral: JoH-C19 |
| Switch off Get Active | Active comparator | After initial randomization, some participants will be assigned to receive Switch Off Get Active Receives: Behavioral: Switch off Get Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Responses to Strengths and Difficulties Questionnaire
Measures children's psychological symptoms and impairments used for children between the ages of 4 to 16. The questionnaire is both parent and youth report and is comprised of five subscales including emotional symptoms, conduct problems, hyperactivity, peer relationship problems, and prosocial behavior. Total difficulty scores which include emotional symptoms, conduct problems, hyper-activity and peer relationship problems subscales range from 0-40. The pro-social behavior subscale ranges from 0-10.
Measured: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Changes in Responses to Pediatric Symptom Checklist-Externalizing Subscale
Parent report measure of emotional and behavioral problems in children. The questionnaire is comprised of three subscales: internalizing, attention, and externalizing. The externalizing subscale will be used for this study. This subscale includes 7-items and the subscale scores range from 0-14.
Measured: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Secondary outcomes (6)
Changes in Responses to Revised Children's Anxiety and Depression Scale-25 (and Subscales) (RCADS)
The Revised Child Anxiety and Depression Scale-25 (RCADS-25) includes 25-items and has both youth self-report and parent report questionnaires. The RCADS-25 is scored on a four point scale from 1-never to 4=Always. Subscales include depression and broad anxiety. The broad anxiety subscale includes 15 items and scores range from 15-60. The depression subscale includes 10-items and scores range from 10-40.
Measured: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Changes in Responses to Family Functioning Systematic Clinical Outcome Routine Evaluation (SCORE-15)
The SCORE-15 has both youth self-report and parent report measures assessing family functioning.The measure is scored on a five-point scale from 1-describes us very well to 5-describes us not at all. Subscales include: Strength and Adaptability which includes 5-items with scores range from 5-25, Overwhelmed by Difficulties which includes 5-items with scores ranging from 5-25, and Disrupted Communication which includes 5-items with scores ranging from 5-25.
Measured: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Changes in Responses to Healthy Pathways Academic Performance Report Academic Subscale
Assesses unidimensional aspects of illness, well-being, and health in youth in transition from childhood to adolescence. the parent-report academic subscale which includes 5-items will be used in this study. The first item inquires how the parent describes the child's grades in schools and ranges from 1=Below Average, D's or F's to 5=Excellent, A's. Items 2-5 ranges from 1=Poor to 5=Excellent. Scale scores on items 2-5 range from 4-20.
Measured: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Changes in Responses to PROMIS Pediatric items (peer relationships)
Assesses the quality of peer relationships and is both parent and child report. The child report version 8-questions with each item ranging from 0=Never to 4=Almost Always. Raw scores range from 0-32.
The parent report version consists of 7 questions with each item ranging from 1=Never to 5=Almost Always. Summed scores range from 8-40 with 8 indicating the lowest quality of peer relationships and 40 indicating the highest quality of peer relationships.
Measured: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Changes in Responses to Child-Parent Relationship Scale
A 15-item parent-report scale that assesses parents views of their relationship with their child. The measure is scored on a 5-point Likert scale ranging from 1=definitely does not apply to 5=definitely applies and consists of two sub-scales: conflict and closeness. An 8-item conflict subscale and assesses perceived negativity in the parent-child relationship. Scores on the conflict subscale range from 8-40 with higher scores representing higher conflict.
A 7-item closeness subscale assesses parents perception of open communication warmth and affection. Scores on the closeness subscale range from 7-35 with higher scores representing greater perceived closeness.
Measured: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Changes in Children's Coping Strategies Checklist (CCSC)
This child-report measure includes 20-items and 5 sub-scales from the CCSC. Subscales include: direct problem solving, positivity, optimism, repression, support for feeling. Each question inquires how often a child uses each coping strategy and is based on a four-point Likert items ranging from 1=Never, 4=Most of the time. Each subscale consists of four items and range from 1 to 20 with higher scores representing greater use of each coping strategy.
Measured: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start15 Nov 2022
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DistressStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Save the Children, Care Connections Mental Wellness and Learning Center, Dickinson Independent School District, Bay District Schools, University of Houston, Baylor College of Medicine, University of South Florida, National Institute of Mental Health (NIMH), Coalition for Compassionate Schools, Boys and Girls Club of Manatee County, Communities in Schools of Galveston County, Communities in Schools Palm Beach, Communities in Schools Gulf South, R'Club Child Care Inc., Boys and Girls Clubs of Tampa Bay
- Responsible party
- Principal investigator, Tara Powell, University of Illinois at Urbana-Champaign
- Investigators
- Tara Leytham Powell, PhD, Principal investigator, University of Illinois Urbana Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639465
- Sponsor's protocol ID
- UIUC IRB 21906
- Other IDs
- 1R01MH131248-01
- Status last verified
- Jan 2026
- First submitted
- 4 Nov 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data can be shared upon request for research purposes and under a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic RCT of a Multi-level Mechanistically Informed Community Intervention to Prevent the Onset of Behavioral Health Symptoms Among Socioeconomically Disadvantaged Pandemic Affected Children
- ClinicalTrials.gov ID
- NCT05639465
- Acronym / sponsor ID
- UIUC IRB 21906
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Save the Children, Care Connections Mental Wellness and Learning Center, Dickinson Independent School District, Bay District Schools, University of Houston, Baylor College of Medicine, University of South Florida, National Institute of Mental Health (NIMH), Coalition for Compassionate Schools, Boys and Girls Club of Manatee County, Communities in Schools of Galveston County, Communities in Schools Palm Beach, Communities in Schools Gulf South, R'Club Child Care Inc., Boys and Girls Clubs of Tampa Bay
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 6 Dec 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.
Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported prevention interventions are needed to prevent the onset of mental and behavioral health issues among these children. Building on our preliminary findings, the proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing behavioral health and interpersonal problems among racial and ethnic minority children who live in low-resource high poverty communities.
Detailed description
The COVID-19 pandemic is having a profound impact on children globally, jeopardizing their sense of safety, security, and behavioral health. In addition to COVID-19, millions of children are still recovering from recent hurricanes that struck the southern the United States. Children exposed to climate-induced disasters (e.g. hurricanes) are at a significant risk for mental and behavioral health challenges. Coupled with an enduring pandemic, many of these children are disproportionately at risk for escalating mental health problems. Racial and ethnic minority children who live in socioeconomically disadvantaged neighborhoods are among the most vulnerable during and after large-scale disasters. They are more likely experience high levels of social and material losses, displacement, and lack of access to mental and physical health services. Thus, there is a critical need for these children to received accessible, empirically supported preventative interventions to mitigate the onset of mental illness and behavioral health issues. Most post-disaster behavioral health interventions are designed to treat rather than prevent mental health conditions and are often inaccessible to racial and ethnic minority children living in socioeconomically disadvantaged communities. The present study, therefore, seeks to examine the implementation and efficacy of the COVID-19 adaptation of a disaster focused empirically supported prevention intervention, the Journey of Hope (JoH), distributed by Save the Children, a humanitarian organization serving socioeconomically disadvantaged and racial and ethnic minority children in communities dually impacted by COVID-19 and recent hurricanes that struck the Southern United States. The long-term goals of this study are to: (1) respond to the critical need of accessible behavioral health interventions designed to prevent and/or reduce COVID-19 related distress; and (2) provide an understanding on how a COVID-19 tailored prevention intervention mitigates behavioral health disparities among racial and ethnic minority children in high poverty settings who have been exposed to multiple large scale disasters. In a pragmatic randomized control trial with 800 children between 3-8th grade, we seek to: Aim 1: Evaluate the efficacy of the COVID-19 adapted JoH (JoH-C19) in preventing behavioral health and interpersonal problems among socioeconomically disadvantaged and racial and ethnic minority children who have been exposed to multiple large-scale disasters relative to a healthy life-style attention control condition. Aim 2: Examine if hypothesized mechanisms of change variables (social connectedness, adaptive coping, self-efficacy) mediate intervention effects (JoH-C19 vs attention control) on child individual behavioral health and interpersonal outcomes. Aim 3: Assess the moderating impact of COVID-19 related stressors on behavioral health outcomes among children who participate in JoH-C19 versus the control condition. Aim 4: Explore implementation barriers, facilitators, and acceptability of the JoH-C19 within school and after-school settings and delivered by community and school-based counselors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JoH-C19 | Experimental | Behavioral: JoH-C19After initial randomization, some participants will be assigned to receive JoH-C19 |
| Switch off Get Active | Active comparator | Behavioral: Switch off Get ActiveAfter initial randomization, some participants will be assigned to receive Switch Off Get Active |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- child experienced the COVID-19 pandemic and an additional large-scale disaster
- child score is 5 or above on the Strengths and Difficulties Questionnaire
- child is in 3- 8th grade at enrollment
- the parent or guardian must complete informed consent and child assent
- child must speak English or Spanish.
Key exclusion criteria (2 listed)
- child is currently receiving treatment for a diagnosed mental health condition
- children who are not able to interact with other students in a group work format, regardless of IEP status
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 |
|---|---|---|
| JoH-C19Journey of Hope- COVID 19 (JoH-C19) includes eight, 1-hour consecutive sessions delivered in groups of 8 children during the school day and in after school settings. The 1.5 hour JoH-C19 caregiver workshop is delivered with groups of 8 parents prior to the child JoH-C19 curriculum | Behavioural | JoH-C19 |
| Switch off Get ActiveSwitch off Get Active covers 4 topics, and its eight, 1- hour sessions are delivered in groups of 8 children. The 1.5 hour Switch Off Get Active caregiver workshop is delivered with groups of 8 parents prior to the Switch off Get Active child curriculum | Behavioural | Switch off Get Active |
Primary outcome
Changes in Responses to Strengths and Difficulties Questionnaire
Time frame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Measures children's psychological symptoms and impairments used for children between the ages of 4 to 16. The questionnaire is both parent and youth report and is comprised of five subscales including emotional symptoms, conduct problems, hyperactivity, peer relationship problems, and prosocial behavior. Total difficulty scores which include emotional symptoms, conduct problems, hyper-activity and peer relationship problems subscales range from 0-40. The pro-social behavior subscale ranges from 0-10.
Changes in Responses to Pediatric Symptom Checklist-Externalizing Subscale
Time frame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Parent report measure of emotional and behavioral problems in children. The questionnaire is comprised of three subscales: internalizing, attention, and externalizing. The externalizing subscale will be used for this study. This subscale includes 7-items and the subscale scores range from 0-14.
6 secondary outcomes
Changes in Responses to Revised Children's Anxiety and Depression Scale-25 (and Subscales) (RCADS)
Time frame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Changes in Responses to Family Functioning Systematic Clinical Outcome Routine Evaluation (SCORE-15)
Time frame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Changes in Responses to Healthy Pathways Academic Performance Report Academic Subscale
Time frame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Changes in Responses to PROMIS Pediatric items (peer relationships)
Time frame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Changes in Responses to Child-Parent Relationship Scale
Time frame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Changes in Children's Coping Strategies Checklist (CCSC)
Time frame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
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 23 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified data can be shared upon request for research purposes and under a data sharing agreement.
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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.
Tara Leytham Powell, PhD principal investigator
University of Illinois Urbana Champaign
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JoH-C19 and Switch off Get Active in people with Emotional Distress and Prosocial Behavior, run by University of Illinois at Urbana-Champaign at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Contact Tara Leytham Powell, PhD (2173000917, tlpowell@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Responses to Strengths and Difficulties Questionnaire (time frame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).). 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 23 Jan 2026.