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Supporting Families of School-Aged Children With ADHD: A Dual-Generation Therapy Approach Through the BRIDGE Program (BRIDGE-ADHD)

3 de novembro de 2026 atualizado por: Tasmia Hai, University of Manitoba

The present research study will evaluate the feasibility and preliminary efficacy of the adapted Building Regulation in Dual Generations program for families of children (8-12 years old) with Attention-Deficit/Hyperactivity Disorder, creating the BRIDGE-ADHD program. The BRIDGE-ADHD program combines 10 weekly online psycho-education sessions with knowledge about ADHD and relevant parenting skills training videos to improve maternal wellbeing and parenting practices, thus supporting children's own psychological wellbeing through an intergenerational approach. This study will specifically evaluate whether the BRIDGE-ADHD program is able to reduce mothers' psychological distress (e.g., depression, anxiety, parenting stress) and simultaneously reduce their children's attention and/or behaviour problems.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Families of children with attention-deficit/hyperactivity disorder (ADHD) often experience elevated parenting stress. Maternal psychological distress (e.g., symptoms of depression and anxiety) is associated with harsher parenting practices that may increase children's risk for both externalizing and internalizing behaviour problems, including ADHD symptoms such as hyperactivity, impulsivity, and inattention. ADHD is in turn associated with deficits in self-regulation and executive functioning, which tend to result in social and academic difficulties that negatively impact the lives of children and families.

Supporting parents through effective parenting strategies is a key modifiable factor that can reduce child behavioural difficulties. Improving parent mental health by reducing parenting stress through skills-based parenting and psychoeducation may reduce parental distress and improve family functioning.

The Building Regulation in Dual Generations program (BRIDGE) for ADHD program is designed to provide mothers with mental health support and parenting skills that promote more effective management of their child's ADHD symptoms and, ultimately, reduce attention and behaviour problems through improvements in self-regulation. BRIDGE-ADHD is an adapted 10 week program that aims to support intergenerational emotion regulation and positive parenting strategies. The program combines dialectical behaviour therapy (DBT) skills with parenting-focused psychoeducational content. Each week, participants will attend a 1.5 hour synchronous online group session led by a licensed clinical psychologist, co facilitated by clinical psychology graduate students under supervision, and a peer parent coach who has previously participated in the BRIDGE program.

This study will use a non-randomized, parallel-assignment feasibility pilot design to evaluate the feasibility and potential efficacy of BRIDGE-ADHD in addressing parenting stress and children's attentional and behavioural problems. We will recruit thirty parent-child dyads (15 intervention participants and 15 normative controls). Participants in the intervention group will complete the 10 week online BRIDGE-ADHD program and in person assessments at two time points: pre intervention (week 0-1; T0) and post intervention (week 10; T1). The normative control group will complete the same in person assessments without participating in the intervention. The primary aim is to examine the feasibility and acceptability of BRIDGE-ADHD and its impact on maternal mental health and children's social-emotional development.

Secondary aims are to evaluate the program's efficacy in reducing parenting stress and decreasing harsh parenting tendencies. Exploratory aims include examining differences or changes in sleep quality, mental well-being, relationships, and child academic achievement before and after participation in BRIDGE-ADHD.

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  • Mothers must be 18 years old or older with both current and elevated symptoms of depression (T-score > 5 on the PHQ-9).

    • Mothers must have a child between the ages of 8 and 12 years old.
    • Both mothers and children must currently live in Manitoba.
    • Mothers must self-report that their child has a diagnosis of ADHD. This will be confirmed by having mothers complete the CBCL (T-score > 65) and through intake interviews with clinicians.
    • Both mothers and children must speak fluent English.
    • Mothers must have neither attempted suicide within the past year nor self-harmed resulting in an injury that either did or should have received medical attention within the past 6 months.

Exclusion Criteria:

  • not meeting the listed criteria above

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: BRIDGE-ADHD

The group that will receive the BRIDGE-ADHD program

The BRIDGE-ADHD program is a 10-week program that combines online psychoeducation sessions with parenting manual handouts and parenting skills training videos to improve maternal wellbeing and promote positive parenting practices tailored to the needs of families of children with ADHD. The BRIDGE-ADHD program content is largely based on mindfulness and dialectical behaviour therapy (DBT) skills, including emotion regulation, distress tolerance, and other related skills. The program will also include psycho-education on ADHD and parenting skills

Sem intervenção: Normative Control

This is a normative control group who will not be receiving any intervention.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Changes in child mental health symptoms following BRIDGE-ADHD intervention
Prazo: This measure will be administered at baseline, (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention which will occur between weeks 11-12 (noted as T1).

Changes in child mental health symptoms will be measured using the Child Behavior Checklist (CBCL) for ages 6 to 18. The CBCL is a 100-item parent-report questionnaire with a range of scores from 0 to 200, measuring child functioning across externalizing and internalizing symptoms. All raw scores are converted into T-scores across all domains tested to have a standardized outcome. Higher T-scores indicate greater symptom severity. We will use the CBCL to assess a) total behaviour problems, b) ADHD subscale scores, c) internalizing behaviours, and d) externalizing behaviours. These subscale scores will collectively be investigated as child mental health symptoms.

This measure will be administered at baseline, (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention which will occur between weeks 11-12 (noted as T1).
Changes in maternal depressive symptoms
Prazo: This measure will be administered at baseline, which is considered week 0-1 (noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention taking place at weeks 11-12 ( noted as T1).

Depressive symptoms will be measured using the Patient Health Questionnaire 9-Item (PHQ-9). The PHQ-9 is a 9-item self-report questionnaire with a range of scores from 0 to 27. Higher scores indicate greater symptom severity.

This measure will be administered at baseline, which is considered week 0-1 (noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention taking place at weeks 11-12 ( noted as T1).
Maternal ratings of program acceptability
Prazo: This measure will be administered after the 10 week of BRIDGE intervention, post-intervention (noted as T1) expected to take place sometime between weeks 11-12.

Maternal ratings of program acceptability will be collected using an open-ended program acceptability questionnaire developed by the research team. Participants will rate how important various components of the program were to them and will be asked to respond to open-ended questions regarding their experience in the program.

This measure will be administered after the 10 week of BRIDGE intervention, post-intervention (noted as T1) expected to take place sometime between weeks 11-12.
Recruitment Feasibility Metrics
Prazo: These will be measured from beginning of the study recruitment till the end of the pilot trial. This time frame can be up to 1 year.

The feasibility of the BRIDGE-ADHD program will be evaluated using a range of implementation metrics. Recruitment feasibility will be assessed by examining eligibility rates, enrollment rates, and the time required to recruit the target sample. All of these measures will be presented in rates allowing for common measurement across domains.

These will be measured from beginning of the study recruitment till the end of the pilot trial. This time frame can be up to 1 year.
Data Collection Feasibility
Prazo: These will be measured from beginning of the study recruitment till the end of the pilot trial. This time frame can be up to 1 year.

The feasibility of the BRIDGE-ADHD program will be evaluated using a range of implementation metrics. Data collection feasibility will be determined by the proportion of participants completing baseline and post-intervention assessments, rates of missing data, and the time required to complete study measures.

These will be measured from beginning of the study recruitment till the end of the pilot trial. This time frame can be up to 1 year.
Program Implementation Outcomes
Prazo: These will be measured from beginning of the study recruitment till the end of the pilot trial. This time frame can be up to 1 year.

Program implementation outcomes, including session attendance, reasons for missed sessions or withdrawal, scheduling challenges, technological issues and facilitator reflections on program delivery

These will be measured from beginning of the study recruitment till the end of the pilot trial. This time frame can be up to 1 year.
Program Retention Measure
Prazo: These will be measured from beginning of the study recruitment till the end of the pilot trial. This time frame can be up to 1 year.

Retention and adherence will be measured by the proportion of participants who complete the program, attendance rates across the 10 sessions, and watching home videos, where applicable.

These will be measured from beginning of the study recruitment till the end of the pilot trial. This time frame can be up to 1 year.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Changes in parent ratings of child behaviours
Prazo: This measure will be administered at baseline, (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention which will occur between weeks 11-12 (noted as T1).

Changes in parent ratings of child behaviours will be measured using the Behaviour Assessment System for Children - Third Edition (BASC-3). The BASC-3 is a parent-report questionnaire measuring externalizing and internalizing problems, attention problems, school problems, as well as adaptive strengths like social skills and study skills. All raw scores are converted into T-scores across all domains tested to have a standardized outcome. Higher T-scores on problem factors indicate more severe problems. Higher T-scores on strengths indicate more of those strengths. We will be specifically looking at broader subscale scores to identify if there has been any change in child behaviours.

This measure will be administered at baseline, (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention which will occur between weeks 11-12 (noted as T1).
Changes in Parenting stress
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Parenting stress will be measured using the Parenting Stress Index Short Form (PSI-SF). The PSI-SF is a self-report questionnaire requiring respondents to answer questions regarding their overall experience of parenting stress using a 5-point Likert with a range of scores range from 36 to 180. All raw scores are converted into T-scores across all domains tested to have a standardized outcome. Higher T-scores indicate higher levels of parenting stress. Changes in total parenting stress score will be measured.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Changes in difficulties with maternal emotion regulation
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in difficulties with emotion regulation will be measured using the Difficulties in Emotion Regulation 36-Item Scale (DERS-36). The DERS-36 is a self-report questionnaire assessing emotion dysregulation across 6 dimensions, including nonacceptance of emotions, difficulties with goal-directed behaviour, impulse control, lack of emotional awareness, limited access to regulation strategies, and lack of emotional clarity. Respondents rate often each statement describes them on a 5-point Likert scale with higher scores indicating greater difficulties. All raw scores are converted into T-scores across all domains tested to have a standardized outcome. Total scores range from 36 to 180 with higher score indicating greater overall difficulties with emotion regulation. Changes in total emotion regulation T-score will be measured.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Changes in maternal feelings of anger
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in anger will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anger subscale. The PROMIS Anger subscale contains 5 items with a range of scores from 5 to 25. Higher scores indicate higher levels of anger.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Changes in maternal sleep problems
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in maternal sleep disturbances will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance subscale short form. The subscale contains 8 items with a range of scores from 8 to 40. Higher scores indicate greater sleep disturbance severity.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Changes in children's sleep habits
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in children's sleep habits will be measured using the Children's Sleep Habits Questionnaire (CSHQ). The CSHQ is a 45-item parent-report questionnaire assessing common sleep problems in children aged 4 to 12, including bedtime resistance and night waking. Higher scores indicate more severe sleep problems with scores above 41 suggesting clinical concerns.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Changes in maternal anxiety symptoms
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Anxiety symptoms will be measured using the Generalized Anxiety Disorder 7-Item Scale (GAD-7). The GAD-7 contains 7 items with a range of scores from 0 to 21. Higher scores indicate higher levels of anxiety symptoms.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Changes in maternal Attention and Hyperactivity symptoms
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in maternal ADHD symptoms will be measured using the Adult ADHD Self-Report Scale (ASRS). The ASRS is an 18-item questionnaire screening for ADHD symptoms in adults based on DSM criteria. Part A of the scale contains 6 items screening for the most predictive symptoms and Part B collects additional details. Total scores range from 0 to 72 with higher scores indicating greater frequency and severity of ADHD symptoms. All raw scores are converted into T-scores across all domains tested to have a standardized outcome.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Measure of Child health
Prazo: This measure will be administered at baseline (noted as T0), expected to occur sometime between weeks 0-1.

Child health will be assessed using a parent-report questionnaire developed by the research team. Parents will be asked to respond to questions about their child's physical and mental health from birth to the present.

This measure will be administered at baseline (noted as T0), expected to occur sometime between weeks 0-1.
Changes in harsh parenting
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in harsh parenting will be measured using the Behaviour Assessment System for Children - Third Edition (BASC-3) Parenting Relationship Questionnaire. The BASC-3 is an 87-item parent-report questionnaire for children aged 2 to 18 years with 7 parenting behaviour subscales, including communication and involvement. Higher scores indicate more of the relevant subscale. Specifically, change in harsh parenting will be measured. All raw scores are converted into T-scores across all domains tested to have standardized outcomes.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Changes in parent report measures of child executive function skills
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in child executive function skills will be measured using the Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2). The BRIEF-2 is a 63-item parent-report questionnaire with 9 subscales, including inhibition, working memory, emotion control, and other clinically relevant subscales. Higher scores on each subscale indicate more of the relevant executive function skill. All raw scores are converted into T-scores across all domains tested to have standardized outcomes.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Changes in academic achievement
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in academic achievement will be measured using the Weschler Individual Achievement Test - Fourth Edition (WIAT-4). The WIAT-4 is an individually administered assessment for ages 4 to 50 measuring 4 key areas of academic achievement, including mathematics, reading, written expression, and oral language. Each of these areas contain several relevant subtests. Raw scores on the WIAT-4 are converted into both percentile ranks and composite subtest scores.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Changes in knowledge, pattern recognition, and problem solving
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in knowledge, pattern recognition, and problem solving will be measured using the Weschler Abbreviated Scale of Intelligence - Second Edition (WASI-II). The WASI-II is a standardized intelligence test for ages 6 to 90 with verbal and nonverbal subtests assessing various aspects of overall cognitive ability. All raw scores are converted into T-scores across all domains tested to have a standardized outcome.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Changes in child core attention skills
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in attention will be measured using the Continuous Performance Test - Third Edition (CPT-3). The CPT-3 is a computerized task measure for individuals aged 8 years or older assessing 4 key components, including inattention, sustained attention, impulsivity, and vigilance. During the task participants are instructed to respond to visual stimuli but ignore other visual stimuli. Performance is based on the number of commissions, omissions, perseverations, hit reaction time, detectability, and other factors.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Changes in child inhibition skills
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in inhibition will be measured using the Neurodevelopmental Assessment for Children - Second Edition (NEPSY-II). The inhibition subtest for ages 5 to 16 assesses impulse control and other components of executive functioning with scaled scores ranging from 1 to19. Higher scores on the inhibition subtest indicate greater response inhibition.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Changes in maternal perceived social support
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in maternal perceived social support from family, friends, and significant others will be measured using the Multidimensional Scale of Perceived Social Support. Total scores range from 12 to 84 with higher scores indicating higher levels of perceived social support.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Service use
Prazo: This measure will be administered at baseline (noted as T0), expected to occur before the beginning of the intervention

Service use will be measured using a service use questionnaire developed by the research team. Participants will be asked questions regarding their interactions with police, child and family services, medical services, and community organizations during the past 1 year.

This measure will be administered at baseline (noted as T0), expected to occur before the beginning of the intervention
Changes in maternal cannabis use
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in maternal cannabis use will be measured using the Cannabis Use Disorder Identification Test (CUDIT). The CUDIT contains 8 items with a range of scores from 0 to 32. Higher scores indicate more hazardous cannabis use.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Changes in maternal alcohol use
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in maternal alcohol use will be measured using the Alcohol Use Disorder Identification Test (AUDIT). The AUDIT contains 10 items with a range of scores from 10 to 40. Higher scores indicate more hazardous or harmful alcohol use.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Changes in recent Stressful Experiences
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

The Recent Stressful Experiences (RSE) checklist was developed according to the recommendations of the JBP Research Network on Toxic Stress from the Center on the Developing Child at Harvard University. The RSE measures familial exposure to various stressors and contains 2 items that ask about stressors which participants may have experienced. Each of these items has a range of scores from 0 to 10 with higher scores indicating more stressful experiences. The RSE also contains 5 items measuring participants' ability to cope with stressful life events. Scores on these 5 items range from 4 to 21 with higher scores indicating a greater ability to cope with stress.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).
Changes in child affection recognition
Prazo: This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

Changes in affect recognition will be measured using the Neurodevelopmental Assessment for Children - Second Edition (NEPSY-II). The affect recognition subtest assesses social perception with scaled scores ranging from 1 to 19. Higher scores on the affect recognition subtest indicate greater ability to identify and discriminate between emotions.

This measure will be administered at baseline (week 0-1; noted as T0) and after 10 weeks of BRIDGE intervention, post-intervention, which will occur between weeks 11-12 (noted as T1).

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Patrocinador

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de novembro de 2026

Conclusão Primária (Estimado)

31 de maio de 2027

Conclusão do estudo (Estimado)

31 de maio de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

6 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de novembro de 2026

Primeira postagem (Real)

9 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de novembro de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • HE2026-0071

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

Given the sensitive nature of the data, we have not decided whether the data can be shared or not.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .