| 1. |
- Jacobson, Dan N O, et al.
(författare)
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A First Clinical Trial on Botulinum Toxin-A for Chronic Muscle-Related Pain in Cerebral Palsy
- 2021
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Ingår i: Frontiers in Neurology. - : Frontiers Media S.A.. - 1664-2295. ; 12
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To test if botulinum toxin-A (BoNT-A) is effective in reducing chronic muscle-related pain in adults with spastic cerebral palsy (CP), as compared to placebo.Design: A single-center, double-blind, parallel, randomized placebo-controlled trial. The design included an interim analysis to allow for confirmatory analysis, as well as pilot study outcomes.Setting: Tertiary university hospital.Participants: Adults with spastic CP and chronic pain associated with spastic muscle(s).Intervention: Treatment was one session of electromyographically guided intramuscular injections of either BoNT-A or placebo normosaline.Main Study Outcomes: The primary outcome was the proportion who achieved a reduction of pain intensity of two or more steps on the Numerical Rating Scale 6 weeks after treatment.Results: Fifty individuals were screened for eligibility, of whom 16 were included (10 female, 6 male, mean age = 32 years, SD = 13.3 years). The randomization yielded eight participants per treatment arm, and all completed the study as randomized. The study was stopped at the interim analysis due to a low probability, under a preset threshold, of a positive primary outcome. Four individuals were treatment responders in the BoNT-A group for the primary outcome compared to five responders in the placebo group (p = 1.000). Adverse events were mild to moderate. In exploratory analysis, the BoNT-A group had a trend of continuing reduction of pain at the last follow-up, after the primary endpoint.Conclusions: This study did not find evidence that BoNT-A was superior to placebo at the desired effect size (number needed to treat of 2.5) at 6 weeks after treatment. Trial registration: ClinicalTrials.gov: NCT02434549
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| 2. |
- Jacobson, Dan N O, et al.
(författare)
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Health-related quality of life, pain, and fatigue in young adults with cerebral palsy
- 2020
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Ingår i: Developmental Medicine & Child Neurology. - : Wiley. - 0012-1622 .- 1469-8749. ; 62:3, s. 372-378
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Tidskriftsartikel (refereegranskat)abstract
- AIM: To describe health-related quality of life (HRQoL), pain, fatigue, and other health variables in young adults with cerebral palsy (CP), and to explore associations with the Gross Motor Function Classification System - Expanded and Revised (GMFCS-ER) and physical activity.METHOD: This was a cross-sectional study of 61 young adults at a mean age of 21 years 2 months (standard deviation 8mo, range 20-22y) with CP, from a geographically defined area. Data collection included: Short Form 36 version 2 for HRQoL, Brief Pain Inventory - Short Form, Fatigue Severity Scale, level of physical activity, medical history, and physical examination.RESULTS: Overall HRQoL equalled that of population norms; however self-reported physical health was lower in GMFCS-ER levels III to V compared to GMFCS-ER levels I to II. Self-reported mental health was, inversely, lower in GMFCS-ER levels I to II compared to GMFCS-ER levels III to V. Pain prevalence was 49%, and pain was present across all GMFCS-ER levels. Fatigue, as well as sleep problems, had 41% prevalence, with fatigue severity decreasing with increasing level of physical activity.INTERPRETATION: General HRQoL in young adults with CP was comparable to population norms. Pain and fatigue are important to address in high motor-functioning individuals also. Physical activity could be a possible protective factor against fatigue.WHAT THIS PAPER ADDS:Health-related quality of life in young adults with cerebral palsy (CP) was comparable to population norms.Pain, fatigue, and sleep problems occurred at all Gross Motor Function Classification System levels.There is a possible protective effect of physical activity on fatigue.
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| 3. |
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| 4. |
- Baraldi, Erika, 1982-, et al.
(författare)
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Early intervention program of extreme preterm born infants, status report three years into the project
- 2021
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Children born extremely preterm (e.g. before 28 gestational weeks, EPT) runs a greater risk of cognitive, motor and neurobehavioral impairment later in life, compared to children born at term. Moreover, being a parent of an EPT born child increases the probability of developing depression and posttraumatic stress disorder post-partum, as well as the premature birth may affect the parent-child interaction negatively. In an attempt to decrease the psychological and motoric negative impact of both the child and parents, our multi-professional team has developed an early intervention during the first year at home focusing om parent-child interaction of the EPT born children: Stockholm Preterm Interaction-Based Intervention, SPIBI (Baraldi et al., 2020a). The target of the RCT is 130 children and after 32 months 112 children has been included in the study, evenly distributed in the intervention group and control group. At children’s corrected age of one-year, parents from 14 of the first included families were interviewed about their experiences from the intervention program, resulting in a qualitative article. Three main themes of parental experiences of the first year at home emerged: child-related concerns (concerning child medical state, self-regulation and recovery), parental inner state (concerning loneliness, ambivalence and premature parental identity), and changed family dynamics (concerning the couple, siblings and intergenerational support). The parents from the intervention group reported that the intervention had given them security, a sense that the interventionist has been knowledgeable and in some cases that the program was important but not necessary to them (Baraldi et al., 2020b). With 85% of the targeted subjects included it is clear that an extensive early home-visit intervention program is feasible in the Swedish context, even though the pandemic has slowed down the recruitment pace and has forced adjustments to be made such as the use of telemedicine, exclusion of toys in the follow-up process and intensified hygienic procedures.
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| 5. |
- Baraldi, Erika, 1982-, et al.
(författare)
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Home-visits during the first year of life : a strengths-based intervention for extremely premature infants and their parents, a randomized-control trial developed in Stockholm Region
- 2020
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- In Sweden 400 children yearly are born extremely preterm (EPT; more than three months early). These children have an increased risk of later academic difficulties, neuropsychiatric disorder, cognitive and mental health issues. Since the first 1000 days of the brain development are so crucial for later development, the interdisciplinary Stockholm Preterm Interaction-Based Intervention (SPIBI) aims at strengthening the parent-child interaction, child development and parental mental health. The research is based on pedagogical, motor-developmental, medical and psychological science. The program is based on Vygotski’s theory of the zone of proximal development, as well theoretical frameworks of early intervention (Guralnick; Shonkoff). Additionally, Als’ synactive theory of understanding premature infant communication and needs, Bowlby’s attachment theory, and Emde’s emotional availability theory have been applied. SPIBI is an ongoing research project funded by Stockholm-County-Stockholm-University joint-collaboration grant 20160881. It is an RCT targeting 130 EPT infants and their parents in Stockholm with a 3-year inclusion period starting September 2018. The intervention consists of ten home-visits during the first year by trained interventionists, supporting the next developmental step of the child through a scaffolding process, strengthening parental sensitivity to infant cues, and promoting infant’s self-regulation. SPIBI has recruited and trained six multi-professional-NICU-experienced interventionists. Control group participants receive TAU plus an extended follow-up program.The overall aim is to present the framework and theory of change of SPIBI, relating to research findings, welfare policies and recommendations for infant’s “chain of care”. So far, sixty eligible infants have been identified within four neonatal units; of which 48 approved participation. The primary outcome is emotional availability of the parent and child, where we hypothesize that the intervention will affect the parental sensitivity and structure of interaction with the child. Secondary outcomes concern child development, i.e. motor development, cognition and occurrence of neuropsychiatric symptoms, parental mental health, anxiety and self-efficacy, where we also hypothesize positive effects of the intervention. Since Nordic countries have neonatal intensive care of high quality, the amount of EPT survivors is high compared to other countries; therefore, the educational systems must follow achievements reached by health care system and develop new evidence-based interventions in early childhood education, which are appropriated for EPT born children and their parents, following recent European Standards of Care for Newborn Health (2018).Insights from neuro-cognition, early intervention and educational research has shown the importance of interdisciplinary interventions, and this should be spread around the Nordic countries.Nordic countries offer a unique social environment, with governmental funded parental-leave, enabling early-interventions delivered by parents.The EPT children in Nordic countries are less affected by socioeconomic factors, as is often the case where maternity welfare and obstetrics is not publically financed. Hence, Nordic countries have a unique opportunity to perform research targeting EPT students and their parents specifically, with less confounding factors.Some Nordic countries have adopted policies concerning home-visiting support and infants’ rights, as recommended by the World Association of Mental health’s policy statement from 2016, and Nordic knowledge exchange and collaboration on these policies is warranted.
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| 6. |
- Baraldi, Erika, 1982-, et al.
(författare)
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Innovative multiprofessional early intervention aiming at improving development of prematurely born children
- 2024
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Abstract: Extremely preterm born children and their parents is a vulnerable group with a high risk of developmental delays, academic challenges and parental mental health difficulties. Previously interventions have been medical focusing of increasing survival, but recently post-discharge interventions improving long-term development have been presented. This abstract concerns a novel multiprofroessional intervention, Stockholm Preterm Interaction-Based Intervention (SPIBI) aiming at consolidation of expertise from educational, behavioral and medical fields in benefit of the child development and family well-being. Rationale and purpose: SPIBIs purpose is to enhance the parent-child interaction, child cognitive and motor development, child preschool social participation and parental mental health in families with extreme preterm born infants.Description of methods, results, or modes of inquiry: In a novel RCT a strengths-based post-discharge intervention targeting extreme preterm born (EPT= born before 28 gestational weeks) infants and their parents is being tested. 130 EPT born children and their parents have been randomly allocated to an intervention group receiving 10 home visits during the first year at home, or a control group receiving treatment as usual with an extended follow-up program. The novel intervention is named Stockholm Preterm Interaction-Based Intervention (SPIBI).Innovation: The field of long-term development of extremely born infants is innovative in itself, since the field consist of a severely vulnerable population on the verge of viability, who did not survive twenty years ago. The innovation in SPIBI is its consolidation of practical knowledge as well as research concerning the challenges of extreme prematurity from a medical (brain developmental), special educational (preschool behavioral), physiotherapeutic (motor), psychological (parent-child-interactional and cognitive) perspective. Working together will benefit the child and family as a whole, since extreme prematurity is a nuanced field with implications for several aspects of development. Despite this, previous international research from the field is almost always unidisciplinary.Implications for policy or practice: The outcome will influence practice at a regional and possible national level, concerning how a low cost early intervention may improve several outcomes and reduce challenges for a group of children with a high risk of developmental delays.Relationship to principles of diversity, equity, and inclusion: The extreme preterm born population often has double challenges, both concerning developmental delays and socioeconomic hardships, both internationally and in a Swedish context. Giving this vulnerable population initial extra support is ultimately a question of equity, increasing the chance of participating in fully inclusive learning environments ahead.Methods used to encourage audience engagement When presenting the poster, these 3 questions will be continuously discussed with researchers passing by:1. What do parents to medically fragile infants who have been balancing on the verge of death, need when the family comes back home from the hospital?2. What are the key elements of multidisciplinary and multiprofessional co-operation between medicine, psychology and special education?3. What may be the different needs of different groups of families with extreme preterm born children, regarding socioeconomic background, severity of prematurity and migration statues?
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| 7. |
- Baraldi, Erika, 1982-, et al.
(författare)
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Insights Gained from Stockholm Preterm Interaction-Based Intervention - A Critical View
- 2022
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Konferensbidrag (refereegranskat)abstract
- SPIBI is a strength-based early intervention targeting parent-child interaction amongst extremely preterm born infants, currently tested in an RCT in Sweden. Of 130 infants, 72% have reached 12 months of age. Based on interviews with 17 parents’ and 6 intervention providers we identified SPIBI strengths and shortcomings. SPIBI seems feasible, is possible to integrate it into home-visiting practice and is appreciated by parents. Identified challenges are geographical distance; recruitment obstacles including Covid-19, leading to longer-term implementation; service-provider fatigue; and social adversities amongst some eligible participants requiring ethical considerations. Future improvements include: reconsidering inclusion criteria, increasing use of e-health, and exploring the possibility of a tiered approach.
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| 8. |
- Baraldi, Erika, 1982-, et al.
(författare)
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Parent–child interaction after home-visiting intervention for children born extremely preterm–A randomised clinical trial
- 2024
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Ingår i: Acta Paediatrica. - 0803-5253 .- 1651-2227. ; 00, s. 1-9
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Tidskriftsartikel (refereegranskat)abstract
- Aim: To determine whether a strength- based home-visiting program enhances par-ent–child interaction during the first year at home for children born extremely pre-term (gestational age < 28). Methods: A randomised controlled trial of 130 infants born extremely preterm 2018–2021 in Stockholm, allocated to either the Stockholm preterm interaction-based in-tervention (SPIBI) (n = 66) or an extended follow-up program (n = 64). The interventiongroup received ten home visits during the first year by a trained interventionist follow-ing SPIBI guidelines: an interaction- based intervention supporting sensitive parentalresponses to infants' signals. The primary outcome of emotional availability was as-sessed at 12 months corrected age (CA) using the emotional availability scales (EAS). Results: At 1-year CA, data were collected from 115/130 (89%) of the includedchildren. There were no significant group differences in emotional availability at12 months CA. A secondary analysis showed an effect modifier in families with moth-ers self-rated as depressed at discharge, with the outcome favouring intervention inthe EAS dimension of child involvement. Conclusion: The SPIBI had no significant main effect on emotional availability at12 months CA. Children of self-reported depressed mothers displayed superior in-volvement behaviour in the intervention group, prompting further research on riskgroups and potential modifications of post-discharge interventions.
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| 9. |
- Baraldi, Erika, 1982-, et al.
(författare)
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Parents’ Experiences of the First Year at Home with an Infant Born Extremely Preterm with and without Post-Discharge Intervention : Ambivalence, Loneliness, and Relationship Impact
- 2020
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Ingår i: International Journal of Environmental Research and Public Health. - : MDPI AG. - 1661-7827 .- 1660-4601. ; 17:24
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Tidskriftsartikel (refereegranskat)abstract
- With increasing survival rates of children born extremely preterm (EPT), before gestational week 28, the post-discharge life of these families has gained significant research interest. Quantitative studies of parental experiences post-discharge have previously reported elevated levels depressive symptoms, posttraumatic stress-disorder and anxiety among the parents. The current investigation aims to qualitatively explore the situation for parents of children born EPT in Sweden during the first year at home. Semi-structured interviews were performed with 17 parents of 14 children born EPT; eight parents were from an early intervention group and nine parents from a group that received treatment as usual, with extended follow-up procedures. Three main themes were identified using a thematic analytic approach: child-related concerns, the inner state of the parent, and changed family dynamics. Parents in the intervention group also expressed themes related to the intervention, as a sense of security and knowledgeable interventionists. The results are discussed in relation to different concepts of health, parent–child interaction and attachment, and models of the recovery processes. In conclusion, parents describe the first year at home as a time of prolonged parental worries for the child as well as concerns regarding the parent’s own emotional state.
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| 10. |
- Baraldi, Erika, 1982-, et al.
(författare)
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Stockholm Preterm Interaction-based Intervention (SPIBI) – Av RCT Assessing Parent-Infant Interaction at 12 Months Corrected Age in Extremely Preterm Born Infants and Their Parents
- 2023
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- BackgroundParental responsiveness is of great importance for positive effects of behavioral and cognitive development in preterm infants and the Emotional availability scales (EAS) is a clinically relevant assessment measure, for early neurodevelopment. The EAS is an observational measure which reflects the quality of parent–child relationship and the child’s socio-emotional development. It has 4 adult domains (sensitivity, structuring, non-intrusiveness, non-hostility) and 2 child domains (responsiveness, involvement) (Biringen 2014). In an ongoing RCT of an intervention for extremely preterm (EPT) born infants and their parents, the Stockholm Preterm Interaction-Based Intervention (SPIBI), the primary outcome measure is EAS used at 12 months corrected age (CA). The aim for this sub-study is to evaluate the inter-rater reliability of EAS in this cohort.MethodDuring the first year after discharge, ten home visits were carried out from specially educated interventionists of our multidisciplinary team. 130 EPT infants were recruited and 115 have been filmed and assessed at 12 months CA. The parent was instructed to play with the infant for 10 minutes. Dyads were filmed, videos assessed and scored by a trained EAS-accredited team member. 20% of the videos (23/115) were assessed by an additional EAS-accreditor to evaluate inter-rater-reliability. Interclass Correlation Coefficient (ICC) were used. To obtain authenticity with real-life, the videos were filmed in a home setting with opportunity to choose study parent. Interaction were encouraged to proceed in an ordinary pattern.ResultsICC values range 0,86 - 0,96 within all dimensions, all individual values, 95%CI (Table 1). This indicates high inter-rater reliability, although some of the subscales had lower ICC (0,73-0,98). ConclusionThe SPIBI study corresponds well with EAS scoring assessment method for reflection of parent-infant interaction at 12 months CA in EPT born infants.
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| 11. |
- Baraldi, Erika, 1982-, et al.
(författare)
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Stockholm preterm interaction-based intervention (SPIBI) - study protocol for an RCT of a 12-month parallel-group post-discharge program for extremely preterm infants and their parents
- 2020
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Ingår i: BMC Pediatrics. - : Springer Science and Business Media LLC. - 1471-2431. ; 20:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: Improved neonatal care has resulted in increased survival rates among infants born after only 22 gestational weeks, but extremely preterm children still have an increased risk of neurodevelopmental delays, learning disabilities and reduced cognitive capacity, particularly executive function deficits. Parent-child interaction and parental mental health are associated with infant development, regardless of preterm birth. There is a need for further early interventions directed towards extremely preterm (EPT) children as well as their parents. The purpose of this paper is to describe the Stockholm Preterm Interaction-Based Intervention (SPIBI), the arrangements of the SPIBI trial and the chosen outcome measurements.Methods: The SPIBI is a randomized clinical trial that includes EPT infants and their parents upon discharge from four neonatal units in Stockholm, Sweden. Inclusion criteria are EPT infants soon to be discharged from a neonatal intensive care unit (NICU), with parents speaking Swedish or English. Both groups receive three initial visits at the neonatal unit before discharge during the recruitment process, with a strengths-based and development-supportive approach. The intervention group receives ten home visits and two telephone calls during the first year from a trained interventionist from a multi-professional team. The SPIBI intervention is a strengths-based early intervention programme focusing on parental sensitivity to infant cues, enhancing positive parent-child interaction, improving self-regulating skills and supporting the infant’s next small developmental step through a scaffolding process and parent-infant co-regulation. The control group receives standard follow-up and care plus extended assessment. The outcomes of interest are parent-child interaction, child development, parental mental health and preschool teacher evaluation of child participation, with assessments at 3, 12, 24 and 36 months corrected age (CA). The primary outcome is emotional availability at 12 months CA.Discussion: If the SPIBI shows positive results, it could be considered for clinical implementation for child-support, ethical and health-economic purposes. Regardless of the outcome, the trial will provide valuable information about extremely preterm children and their parents during infancy and toddlerhood after regional hospital care in Sweden.Trial registration: The study was registered in ClinicalTrials.gov in October 2018 (NCT03714633).
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| 12. |
- Lidbeck, Cecilia, et al.
(författare)
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Motor Development in Children with Cerebral Palsy in Sweden : A Population-Based Longitudinal Register Study
- 2023
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Ingår i: Children. - : MDPI. - 2227-9067. ; 10:12
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Tidskriftsartikel (refereegranskat)abstract
- The aim was to explore longitudinal motor development in children with cerebral palsy (CP) in Sweden with respect to the Gross Motor Function Classification System (GMFCS). In this national CP registry-based study, 2138 children aged 0.5-19 years participated (42% girls). The distribution with respect to GMFCS was I: 49%, II: 16%, III: 10%, IV: 14%, and V: 11%. In total, 5538 assessments (mean 2.7, min-max: 1-9) with the Gross Motor Function Measure-66 were included. Data were analysed using non-linear mixed-effects regression models, and the Stable Limit Model was selected to fit data. Five distinct curves of predicted gross motor development with respect to GMFCS levels were obtained. The achieved motor development was maintained over time. The estimated average GMFM-66 limit and the average age when 90% of the expected limits were reached were at GMFCS I: 88 at age 4.5; GMFCS II: 71 at age 4.2; GMFCS III: 54 at age 3.1; GMFCS IV: 38 at age 2.6, and at GMFCS V: 18 at age 0.9. In conclusion, this is the first national population-based study following motor development in CP. Five distinct curves reported in previous controlled research studies were confirmed. Our study adds knowledge about motor development captured in children's everyday context.
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| 13. |
- Löwing, Kristina, et al.
(författare)
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Do Infants at Risk of Developing Cerebral Palsy or Other Neurodevelopmental Disorders Learn What They Practice?
- 2020
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Ingår i: Journal of Clinical Medicine. - : MDPI AG. - 2077-0383. ; 9:7
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Tidskriftsartikel (refereegranskat)abstract
- Through secondary analyses of the Small Step. Randomized Control Trial, we tested the hypothesis that children at risk of developing cerebral palsy (CP) or other neurodevelopmental disorders would learn what they practice, i.e., that they would have a more rapid development within the specifically trained foci (hand use or mobility) of each time period compared to the development rate within the foci not trained at that time. Nineteen infants (6.3 (1.62) months corrected age) included in the Small Step program were assessed at six time points during the intervention. For statistical analysis, general and mixed linear models were used, and the independent variables were the Peabody Developmental Motor scale (stationary, locomotion, grasping and visuomotor sub scales), the Gross Motor Function Measure-66 and the Hand Assessment for Infants. Outcomes related to gross motor function improved significantly more after mobility training than after hand use training, while fine motor function was improved to the same extent following both training types. Significantly higher improvements after the first training period were seen in one out of three outcome measures in both gross and fine motor assessments. The improvements observed were all independent of diagnosis at two years. The concept “you learn what you practice” was most clearly confirmed in the case of gross motor development.
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| 14. |
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