Preterm BirthNCT04638101
Building the Path to Resilience in Preterm Infants: Mindfulness-based Intervention
A study testing Mindfulness-based intervention in people with Preterm Birth and Cognitive Dysfunction, run by Pediatric Clinical Research Platform.
Trial summary
Yearly 15 million babies worldwide are born too soon. 10% of these preterm births occur very early before 32 weeks of gestation and these newborns are at high risk for neurodevelopmental disorders later in life. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Cognitive Dysfunction, Behavioral Problem
- What is being tested?
- Mindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- born before 32 gestational weeks
Who cannot join
- severe sensory or physical disabilities (cerebral palsy, blindness, hearing loss)
- intelligence quotient below 70
- not French speaking
About this study
Official title: Building the Path to Resilience in Preterm Infants: a Neuroimaging Investigation of the Impact of Multisensory and Neurocognitive Interventions Concern: Mindfulness-based Intervention
Yearly 15 million babies worldwide are born too soon. 10% of these preterm births occur very early before 32 weeks of gestation and these newborns are at high risk for neurodevelopmental disorders later in life. Neurocognitive disorders now touch 27% of the European population, and 5% or 3.3 million children suffer from social and learning difficulties, including attention-deficit hyperactivity disorders and autism, whose rates are increasing and prematurity contributes to this rise. Cognition, and socio-emotional competence are based on intact brain structure and functions that are formed early in development, both pre- and post-natally, and are heavily influenced by environment. Ramon y Cajal in his studies on the making of the brain clearly stated: "The total arborisation of a neuron represents the graphic history of conflicts suffered during its developmental life". Understanding how environment affects early brain development and defining timing and mode of early interventions to enhance brain development in high risk populations, such as preterm infants, is currently acknowledged as a fundamental endeavor for the scientific community (see guidelines of the National Scientific Council for the Developing Child). Interventions to improve and maintain cognitive and socio-emotional skills are to become an essential tool of medical care for high-risk infants. The goal of this study is to test the impact of a Mindfulness-based intervention - considered to target brain networks previously described as affected by prematurity and improve socio-emotional and executive functions. Mindfulness based intervention (intentional self-regulation of attention) will be performed in 10-13 year old preterm children, both from our prior studied preterm cohorts. Overall, our planned research will fill an important gap in our theoretical understanding of the brain vulnerability linked to prematurity. Even more importantly, the compelling issue of how to build cognitive and emotional resilience in preterm children will be addressed by preventing the onset of difficulties and reducing them with appropriate interventions.
- Conditions
- Preterm Birth, Cognitive Dysfunction, Behavioral Problem
- Being tested
- Mindfulness-based intervention
- Medical subject headings
- Premature Birth, Cognitive Dysfunction, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (RCT) | Experimental | Participants from the intervention group participated in the mindfulness-based intervention between Time 1 and Time 2. Receives: Behavioral: Mindfulness-based intervention |
| Waiting group (RCT) | Experimental | Participants from the waiting group took part in the mindfulness-based intervention between Time 2 and Time 3. Receives: Behavioral: Mindfulness-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behaviour Rating Inventory of Executive Function, parent questionnaire (BRIEF; Gioia, Isquith, Guy, and Kenworthy (2000))
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.
Measured: 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))
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.
Measured: 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))
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.
Measured: 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))
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.
Measured: 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))
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.
Measured: 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))
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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))
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.
Measured: 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))
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.
Measured: 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))
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.
Measured: 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))
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.
Measured: 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))
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.
Measured: 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))
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.
Measured: 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))
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.
Measured: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
Letter-Number Sequencing (WISC-IV; Wechsler (2003))
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.
Measured: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
Letter-Number Sequencing (WISC-IV; Wechsler (2003))
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.
Measured: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
Tempo Test Rekenen (De Vos, 1992)
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.
Measured: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
Tempo Test Rekenen (De Vos, 1992)
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.
Measured: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
Tempo Test Rekenen (De Vos, 1992)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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))
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.
Measured: 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))
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.
Measured: 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))
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
Secondary outcomes (2)
Neuroimaging acquisition
(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.
Measured: pre-intervention (Time 1 for "learning group"; Time 2 for "wainting group)
Neuroimaging acquisition
(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.
Measured: immediately after the intervention (Time 2 for "learning group"; Time 3 for "wainting group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Sep 2016
- Primary completion15 Mar 2017
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- For young adolescents enrolled in the randomised controlled trial design, families were randomised either to the intervention group or the waiting group. Participants enrolled in the RCT completed three assessments at three different time points: Time 1, Time 2, Time 3. Participants from the intervention group participated in Mindfulness-based intervention between Time 1 and Time 2. Participants from the waiting group took part in the Mindfulness-based intervention between Time 2 and Time 3.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pediatric Clinical Research Platform
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petra Hüppi, Pediatric Clinical Research Platform
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638101
- Sponsor's protocol ID
- 2015-00175
- Other IDs
- 2015
- Status last verified
- Nov 2020
- First submitted
- 16 Oct 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34615893Siffredi 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.
PubMed 34507019
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building the Path to Resilience in Preterm Infants: a Neuroimaging Investigation of the Impact of Multisensory and Neurocognitive Interventions Concern: Mindfulness-based Intervention
- ClinicalTrials.gov ID
- NCT04638101
- Acronym / sponsor ID
- 2015-00175
- Conditions
- Preterm Birth, Cognitive Dysfunction, Behavioral Problem
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pediatric Clinical Research PlatformUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Yearly 15 million babies worldwide are born too soon. 10% of these preterm births occur very early before 32 weeks of gestation and these newborns are at high risk for neurodevelopmental disorders later in life. Neurocognitive disorders now touch 27% of the European population, and 5% or 3.3 million children suffer from social and learning difficulties, including attention-deficit hyperactivity disorders and autism, whose rates are increasing and prematurity contributes to this rise. Cognition, and socio-emotional competence are based on intact brain structure and functions that are formed early in development, both pre- and post-natally, and are heavily influenced by environment. Ramon y Cajal in his studies on the making of the brain clearly stated: "The total arborisation of a neuron represents the graphic history of conflicts suffered during its developmental life". Understanding how environment affects early brain development and defining timing and mode of early interventions to enhance brain development in high risk populations, such as preterm infants, is currently acknowledged as a fundamental endeavor for the scientific community (see guidelines of the National Scientific Council for the Developing Child). Interventions to improve and maintain cognitive and socio-emotional skills are to become an essential tool of medical care for high-risk infants. The goal of this study is to test the impact of a Mindfulness-based intervention - considered to target brain networks previously described as affected by prematurity and improve socio-emotional and executive functions. Mindfulness based intervention (intentional self-regulation of attention) will be performed in 10-13 year old preterm children, both from our prior studied preterm cohorts. Overall, our planned research will fill an important gap in our theoretical understanding of the brain vulnerability linked to prematurity. Even more importantly, the compelling issue of how to build cognitive and emotional resilience in preterm children will be addressed by preventing the onset of difficulties and reducing them with appropriate interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For young adolescents enrolled in the randomised controlled trial design, families were randomised either to the intervention group or the waiting group. Participants enrolled in the RCT completed three assessments at three different time points: Time 1, Time 2, Time 3. Participants from the intervention group participated in Mindfulness-based intervention between Time 1 and Time 2. Participants from the waiting group took part in the Mindfulness-based intervention between Time 2 and Time 3.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (RCT) | Experimental | Behavioral: Mindfulness-based interventionParticipants from the intervention group participated in the mindfulness-based intervention between Time 1 and Time 2. |
| Waiting group (RCT) | Experimental | Behavioral: Mindfulness-based interventionParticipants from the waiting group took part in the mindfulness-based intervention between Time 2 and Time 3. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- born before 32 gestational weeks
Key exclusion criteria (3 listed)
- severe sensory or physical disabilities (cerebral palsy, blindness, hearing loss)
- intelligence quotient below 70
- not French speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based interventionMindfulness-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. | Behavioural | Intervention group (RCT), Waiting group (RCT) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Neuroimaging acquisition
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Derived from this study: PubMed 34615893Siffredi 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.
- Derived from this study: PubMed 34507019Siffredi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based intervention in people with Preterm Birth and Cognitive Dysfunction, run by Pediatric Clinical Research Platform.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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")). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04638101, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.