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Digital Behavioral Parenting Programs With and Without Added Emotion Regulation Strategies to Manage Anger in Parenting

31 de agosto de 2026 actualizado por: Livia van Leuven, Karolinska Institutet

Digital Parenting Programs to Manage Anger in Parenting: A Pilot Randomized Controlled Trial Comparing Behavioral Parent Training With and Without Added Emotion Regulation Strategies and a Waitlist Control

This pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary effects of two digital parenting interventions for parents experiencing difficulties with anger in parenting. The interventions are internet-delivered adaptations of evidence-based parenting programs, collectively called the Supporting Healthier Interactions in Families by Online Tools (SHIFT) parenting programs. The main questions the study aims to answer are:

  1. Are the study procedures and design feasible for a full-scale RCT?
  2. Are the SHIFT parenting programs feasible and acceptable?
  3. How do therapists and parents experience the SHIFT parenting programs?
  4. Is participation in one of the SHIFT parenting programs, relative to the other and relative to waitlist control, associated with improvements in parent-reported intervention outcomes?
  5. Is participation in the SHIFT parenting programs, relative to each other and waitlist control, associated with improvement in weekly measures of target mechanisms?

Researchers will compare the two programs against each other and against a waitlist control. The first intervention (SHIFT) is a behavioral parent training (BPT) program with parenting strategies to manage child behavior problems. The second intervention (SHIFT+) includes the same BPT strategies with emotion regulation (ER) techniques from anger-management treatments.

Participants will:

  • Be randomized to SHIFT, SHIFT+ or waitlist control.
  • Take part in one of the digital interventions and receive support in text messages and phone calls from a therapist at family support services in Swedish municipalities. Some participants will take part in the intervention after the waitlist period.
  • Respond to questionnaires and take part in interviews.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

BACKGROUND Hard-to-manage anger can impact parenting and increase the risk for interpersonal difficulties, including violence between partners and physical and emotional violence by parents towards children. Several central risk factors for harsh parenting are tied to the caregiver, including hard-to-manage child-directed anger and parenting skills, which are modifiable intervention targets.

Targeting anger in parenting through emotion regulation (ER) strategies that have proven effective for anger problems in adults more broadly represents an under-researched approach. Behavioral parent training (BPT) programs have the strongest research support for reducing harsh and abusive parenting, yet meta-analyses generally show only modest between-group effects. At the same time, cognitive-behavioral interventions incorporating ER strategies have demonstrated efficacy for reducing anger in adults in randomized controlled trials. Integrating such strategies into BPT may offer a promising avenue for enhancing intervention effects, particularly for parents who struggle with anger and emotional escalation.

Delivering interventions digitally can also provide a more efficient and accessible way to reach families, as many families never initiate parenting interventions or discontinue them prematurely due to barriers such as transportation, time constraints, stigma, or shame. Importantly, robust evidence indicates that internet-delivered parenting programs can achieve effects comparable to those of face-to-face interventions.

AIM The overall aim of this project is to evaluate the feasibility, acceptability, and preliminary effects on intervention outcomes and target mechanisms of two newly developed digital parenting interventions, when delivered to parents who experience difficulties with anger in parenthood, compared both to each other and to a waitlist control.

The interventions are internet-delivered adaptations of evidence-based parenting programs, collectively called the Supporting Healthier Interactions in Families by Online Tools (SHIFT) parenting programs. The first intervention is a BPT program (henceforth referred to as SHIFT) that includes parenting strategies to manage child disruptive behavior problems. The parenting strategies are drawn from established BPT programs. The second intervention (henceforth referred to as SHIFT+) integrates the same parenting strategies with emotion regulation (ER) techniques drawn from anger-management treatments. Findings from this study will inform a future large-scale RCT to evaluate the comparative effectiveness of these interventions compared with each other and with a waitlist control.

RESEARCH QUESTIONS

  1. Are the study procedures and design feasible for a full-scale RCT, operationalized as (1) recruiting the target number of participants within a 6 month period, (2) completion of assessments, defined as the proportion of enrolled participants completing intervention outcomes at 8 weeks, and (3) that participants are referred through the tested recruitment pathways?
  2. Are the SHIFT parenting programs feasible and acceptable, operationalized as (1) compliance with the programs, defined as completing at least three of six online modules, (2) parent ratings of satisfaction, credibility and expectancy of the programs, and (3) that social service' family support workers (referred to as 'therapists') provide therapist support consistent with the intervention setup?
  3. How do therapists and parents experience that the digital parenting interventions have influenced parents, as well as therapists' work in supporting families, and how can the interventions be improved?
  4. Is participation in one of the SHIFT parenting programs, relative to participation in the other and relative to waitlist control, associated with improvements in parent-reported intervention outcomes, operationalized as (1) anger in parenthood, (2) parenting practices, (3) parent mental health and distress, and (4) children's mental health and behavior problems, and (5) parent ER, and how large are preliminary effect estimates?
  5. Is participation in the SHIFT-programs, relative to each other and waitlist control, associated with improvement in weekly measures of target mechanisms, operationalized as (1) ER (reappraisal), (2) parenting practices, and (3) children's child disruptive behavior problems, and how large are preliminary effect estimates?

METHODS Recruitment and intervention delivery take place in collaboration with family support services within social services in municipalities across Sweden. The study setting is family support services that parents can access on their own initiative, without requirements on a child welfare report being filed.

The trial will be advertised to parents via municipal webpages and information distributed via local arenas into contact with parents, such as child health care, primary care, schools, preschools, family centers, and local newspapers. Social services/therapists also inform parents during routine contacts.

Parents who are interested in participating will access a study website. On the website, they first read more information about the study. Thereafter, they click on a link to read the detailed study information and provide digital informed consent. In the consent form, the parent indicates whether one or two parents in the family will participate.

When parents have consented to participate, they complete a digital screening. Parents who indicate that they 1) find the digital format suitable, 2) understand Swedish, and 3) score above a cut-off on the Parent Anger Scale (PAS) will be contacted for a telephone screening by the research team. During the telephone screening, the researcher will ensure that the participant has understood the study information, provide opportunity to ask questions, and assess eligibility according to the study's inclusion and exclusion criteria. If two parents take part in the study, the second parent must also complete consent and the baseline assessment before randomization. The second parent do not have to score above the PAS cut-off. Participants who are excluded will be informed of this decision and, where appropriate, referred to other municipal services or local healthcare.

Eligible participants will, after the telephone screening, complete baseline assessments and be randomized to: (1) SHIFT, (2) SHIFT+, or (3) waitlist. These three arms allow both to evaluate effects versus no intervention, and if ER improves the effects of BPT, which will be the focus of the coming full-scale RCT. Parents and a therapist/local study coordinator at each social service unit are informed about the allocation. The therapist/local coordinator assigns a therapist within their team who support parents during the intervention, which is delivered via a secure digital platform.

The researchers collect data by sending parents digital assessments via the platform. Parents complete assessments at baseline (before randomization), weekly during interventions or waitlist period, 8 weeks from baseline (post-assessment), and 6 months from baseline. Parents on the waitlist must complete the post-assessment before starting the intervention. When parents have completed the intervention, therapists also report their satisfaction with the intervention and the support provided during its delivery. Interviews with parents and therapists are conducted after completion of the interventions, following semi-structured interview guides. These will be conducted over telephone, recorded, and transcribed verbatim. All data is collected via the same secure platform as the internet delivered programs are delivered via.

RANDOMIZATION Block randomization with randomly varying block sizes will be used to allocate participants in a 1:1:1 ratio to SHIFT, SHIFT+, or the waitlist condition. The allocation sequence will be generated using a computer-based random number generator with the upcoming allocation concealed.

Randomization will take place after eligibility has been confirmed and the participant has completed the baseline assessment. At that point, the next allocation in the concealed sequence will be retrieved through a secure computerized procedure. Participants allocated to the waitlist will be re-randomized in a 1:1 ratio to receive SHIFT or SHIFT+ following the waiting period and completion of the 8-week assessment. A separate computer-generated allocation sequence with randomly varying block sizes will be used for this second randomization.

ANALYSES Analyses for research question 1: Feasibility of study procedures and design The number of participants recruited, and the recruitment time, is presented descriptively. If we include 80-90 families within 6 months, the trial procedures are considered feasible for a full-scale RCT. The proportion of parents completing intervention outcomes at 8 weeks follow-up will be presented.

Analyses for research question 2: Acceptability and feasibility of the SHIFT programs The proportion of participants who complete at least three of six online modules will be calculated and compared descriptively between the two active programs or with chi2-tests or similar. Group differences in quantitative feasibility ratings (e.g., satisfaction and credibility) will be examined using independent samples t-test or, depending on the number of families with two parents responding, appropriate inferential tests accounting for dependence among observations (e.g., multilevel modelling).

Analyses for research question 3: Experiences of digital interventions Qualitative data from interviews will be transcribed verbatim and analyzed using thematic analysis, content analysis or computationally intensive theory construction to identify patterns in the data, such as themes or categories, that are relevant to the research questions. Illustrative quotes will be presented.

Analyses for research question 4 and 5: Preliminary effects on intervention outcomes and target mechanisms The analyses will follow the intention-to-treat principle, i.e., including all participants as randomized. Effects only for intervention completers will be examined exploratory as a secondary analysis. Preliminary effects of the interventions on parent-rated outcomes assessed at repeated time points will be examined using linear mixed-effects models/generalized linear mixed-effects models or similar appropriate statistical models. Where two parents from the same family participate, nesting will be modelled to account for dependency in the data. At the post-assessment, the two active intervention conditions will be compared both with each other and with the waitlist control condition. At the 6-month follow-up, we will compare the two active interventions and explore whether gains observed in the intervention arms are maintained. At 6 months, participants who are randomized to SHIFT or SHIFT+ after the waitlist period will be included in an analysis comparing the two active interventions. Appropriate effect sizes, such as Cohen's d or odds ratios depending on the type of outcome variable, will be calculated.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

90

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Livia van Leuven van Leuven, PhD
  • Número de teléfono: +46852482796
  • Correo electrónico: livia.van.leuven@ki.se

Ubicaciones de estudio

      • Danderyd, Suecia
        • Danderyds kommun
        • Contacto:
      • Gislaved, Suecia
        • Gislaveds kommun
        • Contacto:
      • Linköping, Suecia
        • Linköpings kommun
        • Contacto:
      • Uppsala, Suecia
        • Uppsala kommun
        • Contacto:
      • Österåker, Suecia
        • Österåkers kommun
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Parent of a child or adolescent aged 2-17 years.
  • Experiences recurring conflicts with the child and recurring anger, irritation, or frustration in parenting situations, and wants strategies to manage situations where conflicts and/or anger occur. Determined via sores above the mean on the Parent Anger Scale (PAS; 10-item Swedish version) based on previous Swedish social service population data, and confirmed in a telephone screening. Another parent in the same family can also participate in the study and program even if they do not experience difficulties with anger.
  • Residing in or near a participating municipality.
  • Can read Swedish and has access to a smartphone, tablet, or computer with internet.
  • Perceives themselves to be able to work relatively independently in a digital intervention and is committed to setting aside time for the intervention.

Exclusion Criteria:

  • Information indicating ongoing or recent violence toward the child perpetrated by parents or other adults in the home.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: The SHIFT parenting program (behavioral parent training program)
Participants assigned to this arm receive a digitally delivered program with parenting strategies.
A 6-week digital parent training program incorporating core components from established behavioral parent training programs. Delivered via a secure digital platform with one module per week, text-based therapist support from family support workers, and two brief check-in telephone calls. Strategies include: strengthening parent-child relationship (e.g., child-directed play), understanding how parents' behavior triggers and reinforces child behavior, selective attention and praise for positive behavior, preparations and effective commands, and natural consequences.
Experimental: The SHIFT+ parenting program (behavioral parent training + emotion regulation strategies)
Participants assigned to this arm receive a digitally delivered program with both parenting strategies and emotion regulation strategies from anger-management treatments.
A 6-week digital program that integrates the same parenting strategies as SHIFT with additional emotion regulation strategies from anger-management treatments. Matched to SHIFT in duration and therapist contact. Emotion regulation strategies include: early identification and interruption of anger escalation, emotional awareness and self-validation, cognitive reappraisal, effective communication, and managing vulnerability to anger.
Otro: Waitlist
Participants wait 8 weeks + completion of post-assessment before receiving SHIFT or SHIFT+.
A 6-week digital parent training program incorporating core components from established behavioral parent training programs. Delivered via a secure digital platform with one module per week, text-based therapist support from family support workers, and two brief check-in telephone calls. Strategies include: strengthening parent-child relationship (e.g., child-directed play), understanding how parents' behavior triggers and reinforces child behavior, selective attention and praise for positive behavior, preparations and effective commands, and natural consequences.
A 6-week digital program that integrates the same parenting strategies as SHIFT with additional emotion regulation strategies from anger-management treatments. Matched to SHIFT in duration and therapist contact. Emotion regulation strategies include: early identification and interruption of anger escalation, emotional awareness and self-validation, cognitive reappraisal, effective communication, and managing vulnerability to anger.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Participant Recruitment: Number of participants recruited
Periodo de tiempo: Baseline
The number of eligible participants recruited within 6 months, or the recruitment time if the target sample size is reached before 6 months. For each participant, this is assessed at baseline (i.e., if the participant is included).
Baseline
Intervention Completion: Completion of at least 3 of 6 modules
Periodo de tiempo: From intervention start to intervention completion, approximately 6 weeks
The proportion of participants who complete at least three of the six online intervention modules. Module completion is assessed through the digital intervention platform from intervention start until intervention completion or dropout.
From intervention start to intervention completion, approximately 6 weeks
Change from baseline on the Multidimensional Assessment of Parenting Scale version 2
Periodo de tiempo: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Parenting practices are assessed using 31 items from the Multidimensional Assessment of Parenting Scale Version 2 (MAPS v2), covering six subscales: Proactive Parenting (6 items), Supportiveness (3 items), Positive Reinforcement (4 items), Warmth (4 items), Hostility (7 items), and Lax Control (7 items). Items are rated on a 5-point Likert scale ranging from 1 (Never) to 5 (Always). The four positive parenting subscales are summed to form a Positive Parenting broadband score ranging from 17 to 85, with higher scores indicating more frequent use of positive parenting practices. Hostility and Lax Control are scored separately, with each subscale ranging from 7 to 35 and higher scores indicating more frequent use of the respective negative parenting practice. The Physical Control subscale of the MAPS v2 is not administered; therefore, a Negative Parenting broadband score is not calculated.
Baseline (before randomization), 8 weeks (primary endpoint), 6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline on the Patient Health Questionnaire (PHQ-9)
Periodo de tiempo: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Parents' symptoms of depression measured using the Patient Health Questionnaire-9 (PHQ-9; 9 items). 4-point Likert scale (0-3), total score 0-27, higher scores = greater severity of depression.
Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Change from baseline on the Parental Flooding Scale
Periodo de tiempo: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Parental flooding assessed using the Parental Flooding Scale (PFS; 15 items). Measures the extent to which parents experience their children's negative affect during conflicts as unexpected, overwhelming, and distressing. 5-point Likert scale (1-5), total score 15-75, higher scores = greater difficulties.
Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Change from screening assessment on the Parent Anger Scale - subscale Experienced Anger
Periodo de tiempo: Screening assessment (before randomization), 8 weeks (primary endpoint), 6 months
Parent-reported anger in parenthood measured using the Experienced Anger subscale of the Parent Anger Scale (PAS; 10-item Swedish version). Captures experienced anger toward children including physiological arousal, brooding, and rumination. 7-point Likert scale (0-6), total score 0-60, higher scores = more frequent anger.
Screening assessment (before randomization), 8 weeks (primary endpoint), 6 months
Change from baseline on the Strengths and Difficulties Questionnaire
Periodo de tiempo: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Child mental health assessed using the parent-rated 25-item Strengths and Difficulties Questionnaire (SDQ). Items rated on a scale of 0-2, total score 0-50, higher scores = greater difficulties.
Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Change from baseline on Oppositional Defiant Disorder (ODD) scale
Periodo de tiempo: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Child disruptive behavior problems assessed using the parent-rated 8-item Oppositional Defiant Disorder (ODD) subscale from a scale assessing Disruptive Behavior Disorder. Rated on a 4-point scale (0-3), total score 0-24, higher scores = more behavior problems.
Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Change from baseline on the Difficulties in Emotion Regulation Scale (DERS-16)
Periodo de tiempo: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Parent-reported emotion regulation assessed using the 16-item Difficulties in Emotion Regulation Scale (DERS-16). 5-point Likert scale (scored 1-5), total score 16-80, higher scores = more difficulties.
Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Assessment completion: completion of 8-week post-assessment
Periodo de tiempo: 8 weeks from baseline
Enrolled parents completing intervention outcomes at the 8-week post-assessment.
8 weeks from baseline
Intervention credibility ratings
Periodo de tiempo: 3 weeks from baseline
Four questions inspired by the Credibility/Expectancy Questionnaire assessing: (1) suitability for target group, (2) belief program will help, (3) willingness to recommend, (4) expected improvement. Each item scored 0-10, total score 0-40, higher = higher credibility.
3 weeks from baseline
Parent-reported intervention satisfaction on the Client Satisfaction Questionnaire (CSQ-8)
Periodo de tiempo: Approximately 8 weeks from baseline
Intervention satisfaction (parent-reported), assessed using the 8-item Client Satisfaction Questionnaire (CSQ-8). Each item scored 1-4, total score 8-32, higher = greater satisfaction.
Approximately 8 weeks from baseline
Therapist intervention satisfaction: Practitioner Acceptability Questionnaire
Periodo de tiempo: Approximately 8 weeks from baseline
To assess intervention satisfaction from the practitioner perspective, therapists complete the Practitioner Acceptability Questionnaire post-intervention. A 7-item instrument rated on a 4-point Likert-scale coded 1-4 (total score: 7-28), with higher score indicating greater satisfaction with the support that parents have taken part in.
Approximately 8 weeks from baseline

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Parents experiences of negative effects of the interventions
Periodo de tiempo: Weekly during intervention and 8 weeks from baseline
Potential negative effects will be assessed post-intervention by asking parents who report that the intervention made their problems worse (based on an item included in the Client Satisfaction Questionnaire [CSQ]) to what extent this negatively affected them or their family. This is assessed using a single item rated on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). In addition, each week during the intervention, parents respond to an open-ended question asking whether the program has caused discomfort, felt burdensome, or had any other negative impact on them or their family during the past week.
Weekly during intervention and 8 weeks from baseline
Weekly change during intervention in parental emotion regulation - reappraisal
Periodo de tiempo: Weekly during intervention period (weeks 1-6 from baseline)
Emotion regulation strategies assessed weekly using the Reappraisal subscale (6 items) of the Revised Parental Emotion Regulation Inventory (R-PERI). 7-point scale (1-7), total score 6-42, higher = better emotion regulation.
Weekly during intervention period (weeks 1-6 from baseline)
Weekly change during intervention in parenting practices (4 item inspired by the MAPS v2)
Periodo de tiempo: Weekly during intervention period (weeks 1-6 from baseline)
Weekly parenting practices assessed using 4 items inspired by the MAPS v2. Positive parenting: 2 items (reflecting Warmth and Positive Reinforcement), score 2-10, higher = more positive. Negative parenting: 2 items (reflecting Lax Control and Hostility), score 2-10, higher = more negative.
Weekly during intervention period (weeks 1-6 from baseline)
Weekly change during intervention in child disruptive behavior
Periodo de tiempo: Weekly during intervention period (weeks 1-6 from baseline)
Weekly child disruptive behavior assessed using 2 items inspired by the ODD subscale. 4-point scale (0-3), higher = more severe disruptive behavior.
Weekly during intervention period (weeks 1-6 from baseline)
Feasibility of recruitment pathways
Periodo de tiempo: At screening
Parents report how they were referred to the study when completing the digital screening, to evaluate the feasibility of tested recruitment pathways. They can choose from pre-specified answering options and provide explanation in free-text.
At screening
Fidelity to therapist support procedures
Periodo de tiempo: Approximately 8 weeks from baseline
The extent to which family support workers provide therapist support in accordance with the specified intervention procedures. Fidelity will be assessed based on the number and content of text messages sent to participants through the digital intervention platform, and therapists' post-intervention reports of the number of telephone calls conducted and whether therapist support was delivered according to the specified intervention procedures.
Approximately 8 weeks from baseline
Parents: Background data
Periodo de tiempo: Baseline
Parents complete questions on their and their child's background (e.g., age, occupation, education, country of birth) and if they have previously taken part in parenting programs.
Baseline
Therapists: Background data
Periodo de tiempo: Baseline
Therapists trained within the project give brief data on their professional experience.
Baseline
Free text feedback by parents
Periodo de tiempo: Weekly during intervention period (weeks 1-6 from baseline)
Each week during the intervention, an open-ended question asks parents on feedback on the intervention content.
Weekly during intervention period (weeks 1-6 from baseline)
Parents: Experiences of digital interventions (qualitative interviews)
Periodo de tiempo: Approximately 10 weeks from baseline
Semi-structured interviews exploring how parents experience that the digital parenting interventions have influenced them and how the interventions can be improved.
Approximately 10 weeks from baseline
Therapists: Experiences of digital interventions (qualitative interviews)
Periodo de tiempo: Approximately 10 weeks from baseline
Semi-structured interviews exploring how therapists experience that the digital parenting interventions have influenced parents, their work in supporting families, and how the interventions can be improved.
Approximately 10 weeks from baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Livia van Leuven, PhD, Karolinska Institutet

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

3 de septiembre de 2026

Finalización primaria (Estimado)

31 de agosto de 2027

Finalización del estudio (Estimado)

31 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

24 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de agosto de 2026

Publicado por primera vez (Actual)

31 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2026-03609-01

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Due to participant confidentiality and university regulations, there is no plan to share individual participant data. This might be revised pending approval from the Swedish Ethical Review Authority. If so, data underlying the results in publications could be shared with other researchers for aggregated analyses, e.g., individual participant data meta-analyses.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .