- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04638101
Building the Path to Resilience in Preterm Infants: Mindfulness-based Intervention
Building the Path to Resilience in Preterm Infants: a Neuroimaging Investigation of the Impact of Multisensory and Neurocognitive Interventions Concern: Mindfulness-based Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- born before 32 gestational weeks
Exclusion Criteria:
- severe sensory or physical disabilities (cerebral palsy, blindness, hearing loss)
- intelligence quotient below 70
- not French speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group (RCT)
Participants from the intervention group participated in the mindfulness-based intervention between Time 1 and Time 2.
|
Mindfulness-based intervention: The proposed MBI was designed based on well-known MBI programs including Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy and adapted to adolescents' needs and language.
The program consisted of 8 weekly sessions in groups of up to 8 participants, lasting 1h30.
Two MBI groups were offered per week (Wednesdays and Fridays) and participants had the possibility to choose the most convenient day for them.
Two instructors were present for each group throughout the intervention.For each session one theme was addressed, such as attention and the stabilisation of the focus of attention, bodily sensations, breath, emotions, thoughts, compassion, stress, stress reactivity and coping strategies.
|
Experimental: Waiting group (RCT)
Participants from the waiting group took part in the mindfulness-based intervention between Time 2 and Time 3.
|
Mindfulness-based intervention: The proposed MBI was designed based on well-known MBI programs including Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy and adapted to adolescents' needs and language.
The program consisted of 8 weekly sessions in groups of up to 8 participants, lasting 1h30.
Two MBI groups were offered per week (Wednesdays and Fridays) and participants had the possibility to choose the most convenient day for them.
Two instructors were present for each group throughout the intervention.For each session one theme was addressed, such as attention and the stabilisation of the focus of attention, bodily sensations, breath, emotions, thoughts, compassion, stress, stress reactivity and coping strategies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behaviour Rating Inventory of Executive Function, parent questionnaire (BRIEF; Gioia, Isquith, Guy, and Kenworthy (2000))
Time Frame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
Executive competences of young adolescents were assessed using the Behaviour Rating Inventory of Executive Function - parent questionnaire version (BRIEF) evaluating attention, hyperactivity and impulsivity in everyday life.
The BRIEF comprises 86 items over two standardised subscales, the Behavioural Regulation Index (BRI) and the Metacognition Index (MI), as well as a global score called the Global Executive Composite (GEC).
These 3 scores will be used as a measure of executive function in daily life.
Higher scores mean worse outcomes.
|
Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
Behaviour Rating Inventory of Executive Function, parent questionnaire (BRIEF; Gioia, Isquith, Guy, and Kenworthy (2000))
Time Frame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
Executive competences of young adolescents were assessed using the Behaviour Rating Inventory of Executive Function - parent questionnaire version (BRIEF) evaluating attention, hyperactivity and impulsivity in everyday life.
The BRIEF comprises 86 items over two standardised subscales, the Behavioural Regulation Index (BRI) and the Metacognition Index (MI), as well as a global score called the Global Executive Composite (GEC).
These 3 scores will be used as a measure of executive function in daily life.
Higher scores mean worse outcomes.
|
Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
Behaviour Rating Inventory of Executive Function, parent questionnaire (BRIEF; Gioia, Isquith, Guy, and Kenworthy (2000))
Time Frame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
Executive competences of young adolescents were assessed using the Behaviour Rating Inventory of Executive Function - parent questionnaire version (BRIEF) evaluating attention, hyperactivity and impulsivity in everyday life.
The BRIEF comprises 86 items over two standardised subscales, the Behavioural Regulation Index (BRI) and the Metacognition Index (MI), as well as a global score called the Global Executive Composite (GEC).
These 3 scores will be used as a measure of executive function in daily life.
Higher scores mean worse outcomes.
|
Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
Strength and Difficulties Questionnaire, parent questionnaire (SDQ; Goodman (2001))
Time Frame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
The SDQ parent questionnaire assess overall behaviour problems, emotional symptoms, hyperactivity and inattention, peer relationship problems, and prosocial behaviour.
It rates participant's behaviour over the previous 6 months.
The SDQ is scored on a Likert scale and includes 25 items, providing a Total Difficulties score.
The Total Difficulties score will be use as a score of behavioural functionning in daily life.
Higher scores mean worse outcomes.
|
Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
Strength and Difficulties Questionnaire, parent questionnaire (SDQ; Goodman (2001))
Time Frame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
The SDQ parent questionnaire assess overall behaviour problems, emotional symptoms, hyperactivity and inattention, peer relationship problems, and prosocial behaviour.
It rates participant's behaviour over the previous 6 months.
The SDQ is scored on a Likert scale and includes 25 items, providing a Total Difficulties score.
The Total Difficulties score will be use as a score of behavioural functionning in daily life.
Higher scores mean worse outcomes.
|
Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
Strength and Difficulties Questionnaire, parent questionnaire (SDQ; Goodman (2001))
Time Frame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
The SDQ parent questionnaire assess overall behaviour problems, emotional symptoms, hyperactivity and inattention, peer relationship problems, and prosocial behaviour.
It rates participant's behaviour over the previous 6 months.
The SDQ is scored on a Likert scale and includes 25 items, providing a Total Difficulties score.
The Total Difficulties score will be use as a score of behavioural functionning in daily life.
Higher scores mean worse outcomes.
|
Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
KIDSCREEN-27 - Self-reported questionnaire (Robitail et al., 2007)
Time Frame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
The KIDSCREEN-27 is a self-reported questionnaire providing an index of health-related quality of life in children and adolescents.
This instrument scored on a Likert scale and includes 27 items, providing a total score.
The total score will be used as a measure of quality of life.
Higher scores mean better outcomes.
|
Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
KIDSCREEN-27 - Self-reported questionnaire (Robitail et al., 2007)
Time Frame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
The KIDSCREEN-27 is a self-reported questionnaire providing an index of health-related quality of life in children and adolescents.
This instrument scored on a Likert scale and includes 27 items, providing a total score.
The total score will be used as a measure of quality of life.
Higher scores mean better outcomes.
|
Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
KIDSCREEN-27 - Self-reported questionnaire (Robitail et al., 2007)
Time Frame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
The KIDSCREEN-27 is a self-reported questionnaire providing an index of health-related quality of life in children and adolescents.
This instrument scored on a Likert scale and includes 27 items, providing a total score.
The total score will be used as a measure of quality of life.
Higher scores mean better outcomes.
|
Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
Social Goal Scale - Self-reported questionnaire (SGS; Patrick, Hicks, and Ryan (1997))
Time Frame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
The SGS is a self-reported questionnaire providing an index of social responsiveness and of goals setting which ultimately gets you involve with some social work.
This instrument scored on a Likert scale and includes 11 items providing one total score that will be used as a measure of social goal.
Higher scores mean better outcomes.
|
Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
Social Goal Scale - Self-reported questionnaire (SGS; Patrick, Hicks, and Ryan (1997))
Time Frame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
The SGS is a self-reported questionnaire providing an index of social responsiveness and of goals setting which ultimately gets you involve with some social work.
This instrument scored on a Likert scale and includes 11 items providing one total score that will be used as a measure of social goal.
Higher scores mean better outcomes.
|
Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
Social Goal Scale - Self-reported questionnaire (SGS; Patrick, Hicks, and Ryan (1997))
Time Frame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
The SGS is a self-reported questionnaire providing an index of social responsiveness and of goals setting which ultimately gets you involve with some social work.
This instrument scored on a Likert scale and includes 11 items providing one total score that will be used as a measure of social goal.
Higher scores mean better outcomes.
|
Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
Self-Compassion Scale - Short form - Self-reported questionnaire (SCS; Raes, Pommier, Neff, and Van Gucht (2011))
Time Frame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
The SCS is a self-reported questionnaire comprising 12 items, which produces a total global score.
The total global score will be used as a measure of self compassion.
Higher scores mean better outcomes.
|
Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
Self-Compassion Scale - Short form - Self-reported questionnaire (SCS; Raes, Pommier, Neff, and Van Gucht (2011))
Time Frame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
The SCS is a self-reported questionnaire comprising 12 items, which produces a total global score.
The total global score will be used as a measure of self compassion.
Higher scores mean better outcomes.
|
Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
Self-Compassion Scale - Short form - Self-reported questionnaire (SCS; Raes, Pommier, Neff, and Van Gucht (2011))
Time Frame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
The SCS is a self-reported questionnaire comprising 12 items, which produces a total global score.
The total global score will be used as a measure of self compassion.
Higher scores mean better outcomes.
|
Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
Letter-Number Sequencing (WISC-IV; Wechsler (2003))
Time Frame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
The letter-number sequencing is a working memory task.
Sequences of number and letters are read to the participant, and he/she is then asked to re-sequence the numbers in numerical order from lowest to highest and then to sequence the letters in alphabetical order.
Standardised total scores will be used as a measure of working memory.
Higher scores mean better outcomes.
|
Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
Letter-Number Sequencing (WISC-IV; Wechsler (2003))
Time Frame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
The letter-number sequencing is a working memory task.
Sequences of number and letters are read to the participant, and he/she is then asked to re-sequence the numbers in numerical order from lowest to highest and then to sequence the letters in alphabetical order.
Standardised total scores will be used as a measure of working memory.
Higher scores mean better outcomes.
|
Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
Letter-Number Sequencing (WISC-IV; Wechsler (2003))
Time Frame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
The letter-number sequencing is a working memory task.
Sequences of number and letters are read to the participant, and he/she is then asked to re-sequence the numbers in numerical order from lowest to highest and then to sequence the letters in alphabetical order.
Standardised total scores will be used as a measure of working memory.
Higher scores mean better outcomes.
|
Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
Tempo Test Rekenen (De Vos, 1992)
Time Frame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
The Tempo Test Rekenen is an arithmetic test consisting of 200 arithmetic number fact problems presented in five rows (one row with addition, one row with subtraction, one row with division, one row with multiplication, and one mixed problem row).
Within each row, the problems increase in difficulty.
Participant are asked to solve as many items as possible within 1 min per row.
The total raw score will be age-adjusted for each participant and used as a measure of arithmetic competences.
Higher scores mean better outcomes.
|
Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
Tempo Test Rekenen (De Vos, 1992)
Time Frame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
The Tempo Test Rekenen is an arithmetic test consisting of 200 arithmetic number fact problems presented in five rows (one row with addition, one row with subtraction, one row with division, one row with multiplication, and one mixed problem row).
Within each row, the problems increase in difficulty.
Participant are asked to solve as many items as possible within 1 min per row.
The total raw score will be age-adjusted for each participant and used as a measure of arithmetic competences.
Higher scores mean better outcomes.
|
Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
Tempo Test Rekenen (De Vos, 1992)
Time Frame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
The Tempo Test Rekenen is an arithmetic test consisting of 200 arithmetic number fact problems presented in five rows (one row with addition, one row with subtraction, one row with division, one row with multiplication, and one mixed problem row).
Within each row, the problems increase in difficulty.
Participant are asked to solve as many items as possible within 1 min per row.
The total raw score will be age-adjusted for each participant and used as a measure of arithmetic competences.
Higher scores mean better outcomes.
|
Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
Affect Recognition (NEPSY-II; Korkman, Kirk, and Kemp (2007)
Time Frame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
The affect recognition subtest assesses the ability to recognise facial emotional expressions (happy, sad, anger, fear, disgust, and neutral) from photographs of children's faces in several matching tasks.
In the first task, the participant selected one of the four faces that depicted the same emotion as a child's face at the top of the page.
In a second task, the participant selected two photographs of faces that displayed the same affect from a selection of four photographs.
Finally, the participant examined a photograph of a child's face for 5 seconds, and then from memory, selected two photographs that matched the same emotion as the face previously shown.
Standardised scores will be used.
Higher scores mean better outcomes.
|
Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
Affect Recognition (NEPSY-II; Korkman, Kirk, and Kemp (2007)
Time Frame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
The affect recognition subtest assesses the ability to recognise facial emotional expressions (happy, sad, anger, fear, disgust, and neutral) from photographs of children's faces in several matching tasks.
In the first task, the participant selected one of the four faces that depicted the same emotion as a child's face at the top of the page.
In a second task, the participant selected two photographs of faces that displayed the same affect from a selection of four photographs.
Finally, the participant examined a photograph of a child's face for 5 seconds, and then from memory, selected two photographs that matched the same emotion as the face previously shown.
Standardised scores will be used.
Higher scores mean better outcomes.
|
Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
Affect Recognition (NEPSY-II; Korkman, Kirk, and Kemp (2007)
Time Frame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
The affect recognition subtest assesses the ability to recognise facial emotional expressions (happy, sad, anger, fear, disgust, and neutral) from photographs of children's faces in several matching tasks.
In the first task, the participant selected one of the four faces that depicted the same emotion as a child's face at the top of the page.
In a second task, the participant selected two photographs of faces that displayed the same affect from a selection of four photographs.
Finally, the participant examined a photograph of a child's face for 5 seconds, and then from memory, selected two photographs that matched the same emotion as the face previously shown.
Standardised scores will be used.
Higher scores mean better outcomes.
|
Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
Theory of Mind (NEPSY-II; Korkman et al. (2007))
Time Frame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
The theory of mind subtest measures understanding of mental functions and other people's perspectives. In the first task, questions are asked to the participant about different verbal scenarios measuring understanding of beliefs, intentions, others' thoughts, ideas and comprehension of figurative language. In the second task, participants have to match facial emotional expressions, from photographs of children's faces, to a scenario. The total raw score willl be age-adjusted. Higher scores mean better outcomes. |
Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
Theory of Mind (NEPSY-II; Korkman et al. (2007))
Time Frame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
The theory of mind subtest measures understanding of mental functions and other people's perspectives. In the first task, questions are asked to the participant about different verbal scenarios measuring understanding of beliefs, intentions, others' thoughts, ideas and comprehension of figurative language. In the second task, participants have to match facial emotional expressions, from photographs of children's faces, to a scenario. The total raw score willl be age-adjusted. Higher scores mean better outcomes. |
Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
Theory of Mind (NEPSY-II; Korkman et al. (2007))
Time Frame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
The theory of mind subtest measures understanding of mental functions and other people's perspectives. In the first task, questions are asked to the participant about different verbal scenarios measuring understanding of beliefs, intentions, others' thoughts, ideas and comprehension of figurative language. In the second task, participants have to match facial emotional expressions, from photographs of children's faces, to a scenario. The total raw score willl be age-adjusted. Higher scores mean better outcomes. |
Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
Flanker Visual Filtering Task (Christ, Kester, Bodner, & Miles, 2011)
Time Frame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
The Flanker Visual Filtering Task was used to assess attentional control and information processing speed.
Each trial showed a horizontal row of five fish.
The participant was asked to respond as quickly as possible to whether the central fish was facing to the left or right.
Congruent trials were the ones with all five fish in the horizontal row pointing in the same direction and incongruent trials were the ones with the four distracting fishes pointing in the opposite direction of the central target fish.
Reaction time of the congruent condition and of the incongruent condition were used to assess information processing speed, and the inhibition score (reaction time in incongruent conditions - reaction time in congruent conditions) was used as a measure of attentional control.
Higher scores (reaction time) mean worse outcomes.
|
Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
Flanker Visual Filtering Task (Christ, Kester, Bodner, & Miles, 2011)
Time Frame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
The Flanker Visual Filtering Task was used to assess attentional control and information processing speed.
Each trial showed a horizontal row of five fish.
The participant was asked to respond as quickly as possible to whether the central fish was facing to the left or right.
Congruent trials were the ones with all five fish in the horizontal row pointing in the same direction and incongruent trials were the ones with the four distracting fishes pointing in the opposite direction of the central target fish.
Reaction time of the congruent condition and of the incongruent condition were used to assess information processing speed, and the inhibition score (reaction time in incongruent conditions - reaction time in congruent conditions) was used as a measure of attentional control.
Higher scores (reaction time) mean worse outcomes.
|
Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
Flanker Visual Filtering Task (Christ, Kester, Bodner, & Miles, 2011)
Time Frame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
The Flanker Visual Filtering Task was used to assess attentional control and information processing speed.
Each trial showed a horizontal row of five fish.
The participant was asked to respond as quickly as possible to whether the central fish was facing to the left or right.
Congruent trials were the ones with all five fish in the horizontal row pointing in the same direction and incongruent trials were the ones with the four distracting fishes pointing in the opposite direction of the central target fish.
Reaction time of the congruent condition and of the incongruent condition were used to assess information processing speed, and the inhibition score (reaction time in incongruent conditions - reaction time in congruent conditions) was used as a measure of attentional control.
Higher scores (reaction time) mean worse outcomes.
|
Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
Reality Filtering Task (Liverani et al., 2017; Schnider, 2018)
Time Frame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
The Reality Filtering task child-adapted version was used to assess recognition memory and orbitofrontal reality filtering.
It consisted of a continuous recognition task composed of two runs with the same picture set but arranged in different order.
Accuracy of the second run (D2) and Temporal Context Confusion index (TCC as defined by Schnider, 2018) measures reality filtering.
Higher scores mean better outcomes.
|
Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
|
Reality Filtering Task (Liverani et al., 2017; Schnider, 2018)
Time Frame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
The Reality Filtering task child-adapted version was used to assess recognition memory and orbitofrontal reality filtering.
It consisted of a continuous recognition task composed of two runs with the same picture set but arranged in different order.
Accuracy of the second run (D2) and Temporal Context Confusion index (TCC as defined by Schnider, 2018) measures reality filtering.
Higher scores mean better outcomes.
|
Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
|
Reality Filtering Task (Liverani et al., 2017; Schnider, 2018)
Time Frame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
The Reality Filtering task child-adapted version was used to assess recognition memory and orbitofrontal reality filtering.
It consisted of a continuous recognition task composed of two runs with the same picture set but arranged in different order.
Accuracy of the second run (D2) and Temporal Context Confusion index (TCC as defined by Schnider, 2018) measures reality filtering.
Higher scores mean better outcomes.
|
Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuroimaging acquisition
Time Frame: pre-intervention (Time 1 for "learning group"; Time 2 for "wainting group)
|
(i) High resolution structural T1-weighted MP-RAGE (Magnetization Prepared Rapid Gradient Echo) sequence. (ii) Functional images were T2*-weighted with a multislice gradient-echo-planar imaging (EPI) sequence, including Resting-State fMRI data for which participants were asked to lie still with their eyes closed and engage into mind wandering and task-related activation paradigm (Flanker Visual Filtering Task, Reality Filtering task, Emotion Regulation task used to assessed emotional regulation functions (Samson, Kreibig, Soderstrom, Wade, & Gross, 2016) and the Recognition of Emotions in Contextual Scene task used to assessed facial emotional expression recognition based on contextual cues (Theurel et al., 2016)). (iii) Diffusion-weighted imaging (DWI) sequences were acquired with 1.3 mm3 isotropic voxels with four different shells. |
pre-intervention (Time 1 for "learning group"; Time 2 for "wainting group)
|
Neuroimaging acquisition
Time Frame: immediately after the intervention (Time 2 for "learning group"; Time 3 for "wainting group)
|
(i) High resolution structural T1-weighted MP-RAGE (Magnetization Prepared Rapid Gradient Echo) sequence. (ii) Functional images were T2*-weighted with a multislice gradient-echo-planar imaging (EPI) sequence, including Resting-State fMRI data for which participants were asked to lie still with their eyes closed and engage into mind wandering and task-related activation paradigm (Flanker Visual Filtering Task, Reality Filtering task, Emotion Regulation task used to assessed emotional regulation functions (Samson, Kreibig, Soderstrom, Wade, & Gross, 2016) and the Recognition of Emotions in Contextual Scene task used to assessed facial emotional expression recognition based on contextual cues (Theurel et al., 2016)). (iii) Diffusion-weighted imaging (DWI) sequences were acquired with 1.3 mm3 isotropic voxels with four different shells. |
immediately after the intervention (Time 2 for "learning group"; Time 3 for "wainting group)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Siffredi V, Liverani MC, Huppi PS, Freitas LGA, De Albuquerque J, Gimbert F, Merglen A, Meskaldji DE, Borradori Tolsa C, Ha-Vinh Leuchter R. The effect of a mindfulness-based intervention on executive, behavioural and socio-emotional competencies in very preterm young adolescents. Sci Rep. 2021 Oct 6;11(1):19876. doi: 10.1038/s41598-021-98608-2.
- Siffredi V, Liverani MC, Smith MM, Meskaldji DE, Stuckelberger-Grobety F, Freitas LGA, De Albuquerque J, Savigny E, Gimbert F, Huppi PS, Merglen A, Borradori Tolsa C, Leuchter RH. Improving executive, behavioural and socio-emotional competences in very preterm young adolescents through a mindfulness-based intervention: Study protocol and feasibility. Early Hum Dev. 2021 Oct;161:105435. doi: 10.1016/j.earlhumdev.2021.105435. Epub 2021 Jul 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-00175
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Shanghai Ninth People's Hospital Affiliated to...RecruitingPOCD - Postoperative Cognitive DysfunctionChina
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Mu Dong LiangNot yet recruitingPostoperative Cognitive Dysfunction(POCD)
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HealthPartners InstituteCompletedPost Operative Cognitive DysfunctionUnited States
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Burcu Ozalp HorsanaliCompletedPost Operative Cognitive Dysfunction
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ImmunoChem Therapeutics, LLCNational Cancer Institute (NCI); Northwestern MedicineRecruitingCognitive Dysfunction, Cognitive DisorderUnited States
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Attikon HospitalCompleted
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Xijing HospitalFirst Affiliated Hospital Xi'an Jiaotong University; Shanghai 10th People's... and other collaboratorsTerminatedPost Operative Cognitive DysfunctionChina
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Icahn School of Medicine at Mount SinaiNational Institute on Aging (NIA)CompletedPost Operative Cognitive DysfunctionUnited States
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Mayo ClinicCompletedCognitive Impairment | Mild Cognitive Impairment | Neurocognitive DysfunctionUnited States
Clinical Trials on Mindfulness-based intervention
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Singapore General HospitalCompletedDepression | Stroke | Stress | AnxietySingapore
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Jordan University of Science and TechnologyCompleted
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Hospital Miguel ServetCompleted
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IRCCS Centro San Giovanni di Dio FatebenefratelliCompleted
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The Hong Kong Polytechnic UniversityCompleted
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University of PisaCompletedDepression | Anxiety | Child, Only | TemperamentItaly
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Bar-Ilan University, IsraelCompletedPsychologicalIsrael
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Sunnybrook Health Sciences CentreRecruiting
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Jordan University of Science and TechnologyCompleted