Clinical trial NCT04638101: Building the Path to Resilience in Preterm Infants: Mindfulness-based Intervention
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Preterm Birth
Cognitive Dysfunction
Behavioral Problem
Lead sponsor: Pediatric Clinical Research Platform
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Behaviour Rating Inventory of Executive Function, parent questionnaire (BRIEF; Gioia, Isquith, Guy, and Kenworthy (2000))
timeFrame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
measure: Behaviour Rating Inventory of Executive Function, parent questionnaire (BRIEF; Gioia, Isquith, Guy, and Kenworthy (2000))
timeFrame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
measure: Behaviour Rating Inventory of Executive Function, parent questionnaire (BRIEF; Gioia, Isquith, Guy, and Kenworthy (2000))
timeFrame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
measure: Strength and Difficulties Questionnaire, parent questionnaire (SDQ; Goodman (2001))
timeFrame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
measure: Strength and Difficulties Questionnaire, parent questionnaire (SDQ; Goodman (2001))
timeFrame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
measure: Strength and Difficulties Questionnaire, parent questionnaire (SDQ; Goodman (2001))
timeFrame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
measure: KIDSCREEN-27 - Self-reported questionnaire (Robitail et al., 2007)
timeFrame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
measure: KIDSCREEN-27 - Self-reported questionnaire (Robitail et al., 2007)
timeFrame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
measure: KIDSCREEN-27 - Self-reported questionnaire (Robitail et al., 2007)
timeFrame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
measure: Social Goal Scale - Self-reported questionnaire (SGS; Patrick, Hicks, and Ryan (1997))
timeFrame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
measure: Social Goal Scale - Self-reported questionnaire (SGS; Patrick, Hicks, and Ryan (1997))
timeFrame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
measure: Social Goal Scale - Self-reported questionnaire (SGS; Patrick, Hicks, and Ryan (1997))
timeFrame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
measure: Self-Compassion Scale - Short form - Self-reported questionnaire (SCS; Raes, Pommier, Neff, and Van Gucht (2011))
timeFrame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
measure: Self-Compassion Scale - Short form - Self-reported questionnaire (SCS; Raes, Pommier, Neff, and Van Gucht (2011))
timeFrame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
measure: Self-Compassion Scale - Short form - Self-reported questionnaire (SCS; Raes, Pommier, Neff, and Van Gucht (2011))
timeFrame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
measure: Letter-Number Sequencing (WISC-IV; Wechsler (2003))
timeFrame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
measure: Letter-Number Sequencing (WISC-IV; Wechsler (2003))
timeFrame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
measure: Letter-Number Sequencing (WISC-IV; Wechsler (2003))
timeFrame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
measure: Tempo Test Rekenen (De Vos, 1992)
timeFrame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
measure: Tempo Test Rekenen (De Vos, 1992)
timeFrame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
measure: Tempo Test Rekenen (De Vos, 1992)
timeFrame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
measure: Affect Recognition (NEPSY-II; Korkman, Kirk, and Kemp (2007)
timeFrame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
measure: Affect Recognition (NEPSY-II; Korkman, Kirk, and Kemp (2007)
timeFrame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
measure: Affect Recognition (NEPSY-II; Korkman, Kirk, and Kemp (2007)
timeFrame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
measure: Theory of Mind (NEPSY-II; Korkman et al. (2007))
timeFrame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
measure: Theory of Mind (NEPSY-II; Korkman et al. (2007))
timeFrame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
measure: Theory of Mind (NEPSY-II; Korkman et al. (2007))
timeFrame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
measure: Flanker Visual Filtering Task (Christ, Kester, Bodner, & Miles, 2011)
timeFrame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
measure: Flanker Visual Filtering Task (Christ, Kester, Bodner, & Miles, 2011)
timeFrame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
measure: Flanker Visual Filtering Task (Christ, Kester, Bodner, & Miles, 2011)
timeFrame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
measure: Reality Filtering Task (Liverani et al., 2017; Schnider, 2018)
timeFrame: Assessment at Time 1 (pre-intervention for "learning group"; pre-treatment as usual for "waiting group")
measure: Reality Filtering Task (Liverani et al., 2017; Schnider, 2018)
timeFrame: Assessment at Time 2 (immediately after the intervention for "learning group"; pre-intervention for "waiting group")
measure: Reality Filtering Task (Liverani et al., 2017; Schnider, 2018)
timeFrame: Assessment at Time 3 (3 months post-intervention for "learning group"; immediately after the intervention for "waiting group")
Secondary outcomes:
measure: Neuroimaging acquisition
timeFrame: pre-intervention (Time 1 for "learning group"; Time 2 for "wainting group)
measure: Neuroimaging acquisition
timeFrame: immediately after the intervention (Time 2 for "learning group"; Time 3 for "wainting group)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.