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Extended-release guanfacine hydrochloride in 6–17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study / Jeffrey H. NEWCORN in Journal of Child Psychology and Psychiatry, 57-6 (June 2016)
[article]
Titre : Extended-release guanfacine hydrochloride in 6–17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study Type de document : Texte imprimé et/ou numérique Auteurs : Jeffrey H. NEWCORN, Auteur ; Valerie HARPIN, Auteur ; Michael HUSS, Auteur ; Andrew LYNE, Auteur ; Vanja SIKIRICA, Auteur ; Mats JOHNSON, Auteur ; Josep Antoni RAMOS-QUIROGA, Auteur ; Judy VAN STRALEN, Auteur ; Benoit DUTRAY, Auteur ; Sasha SRECKOVIC, Auteur ; Ralph BLOOMFIELD, Auteur ; Brigitte ROBERTSON, Auteur Article en page(s) : p.717-728 Langues : Anglais (eng) Mots-clés : Long term efficacy randomised withdrawal attention-deficit/hyperactivity disorder guanfacine Index. décimale : PER Périodiques Résumé : Background Extended-release guanfacine hydrochloride (GXR), a selective ?2A-adrenergic agonist, is a nonstimulant medication for attention-deficit/hyperactivity disorder (ADHD). This phase 3, double-blind, placebo-controlled, randomised-withdrawal study evaluated the long-term maintenance of GXR efficacy in children/adolescents with ADHD. Methods Children/adolescents (6–17 years) with ADHD received open-label GXR (1–7 mg/day). After 13 weeks, responders were randomised to GXR or placebo in the 26-week, double-blind, randomised-withdrawal phase (RWP). The primary endpoint was the percentage of treatment failure (?50% increase in ADHD Rating Scale version IV total score and ?2-point increase in Clinical Global Impression-Severity compared with RWP baseline, at two consecutive visits). The key secondary endpoint was time to treatment failure (TTF). Trial registration ClinicalTrials.gov identifier NCT01081145; EudraCT 2009-018161-12. Results A total of 528 participants enrolled; 316 (59.8%) entered the RWP. Treatment failure occurred in 49.3% of the GXR and 64.9% of the placebo group (p = 0.006). TTF was significantly longer in GXR versus placebo (p = 0.003). GXR was well tolerated. Conclusions Guanfacine hydrochloride demonstrated long-term maintenance of efficacy compared with placebo in children/adolescents with ADHD. Implications of the placebo substitution design and findings with different ADHD medications are discussed. En ligne : http://dx.doi.org/10.1111/jcpp.12492 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=289
in Journal of Child Psychology and Psychiatry > 57-6 (June 2016) . - p.717-728[article] Extended-release guanfacine hydrochloride in 6–17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study [Texte imprimé et/ou numérique] / Jeffrey H. NEWCORN, Auteur ; Valerie HARPIN, Auteur ; Michael HUSS, Auteur ; Andrew LYNE, Auteur ; Vanja SIKIRICA, Auteur ; Mats JOHNSON, Auteur ; Josep Antoni RAMOS-QUIROGA, Auteur ; Judy VAN STRALEN, Auteur ; Benoit DUTRAY, Auteur ; Sasha SRECKOVIC, Auteur ; Ralph BLOOMFIELD, Auteur ; Brigitte ROBERTSON, Auteur . - p.717-728.
Langues : Anglais (eng)
in Journal of Child Psychology and Psychiatry > 57-6 (June 2016) . - p.717-728
Mots-clés : Long term efficacy randomised withdrawal attention-deficit/hyperactivity disorder guanfacine Index. décimale : PER Périodiques Résumé : Background Extended-release guanfacine hydrochloride (GXR), a selective ?2A-adrenergic agonist, is a nonstimulant medication for attention-deficit/hyperactivity disorder (ADHD). This phase 3, double-blind, placebo-controlled, randomised-withdrawal study evaluated the long-term maintenance of GXR efficacy in children/adolescents with ADHD. Methods Children/adolescents (6–17 years) with ADHD received open-label GXR (1–7 mg/day). After 13 weeks, responders were randomised to GXR or placebo in the 26-week, double-blind, randomised-withdrawal phase (RWP). The primary endpoint was the percentage of treatment failure (?50% increase in ADHD Rating Scale version IV total score and ?2-point increase in Clinical Global Impression-Severity compared with RWP baseline, at two consecutive visits). The key secondary endpoint was time to treatment failure (TTF). Trial registration ClinicalTrials.gov identifier NCT01081145; EudraCT 2009-018161-12. Results A total of 528 participants enrolled; 316 (59.8%) entered the RWP. Treatment failure occurred in 49.3% of the GXR and 64.9% of the placebo group (p = 0.006). TTF was significantly longer in GXR versus placebo (p = 0.003). GXR was well tolerated. Conclusions Guanfacine hydrochloride demonstrated long-term maintenance of efficacy compared with placebo in children/adolescents with ADHD. Implications of the placebo substitution design and findings with different ADHD medications are discussed. En ligne : http://dx.doi.org/10.1111/jcpp.12492 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=289 Intervening with Attachment and Biobehavioral Catch-Up to decrease disrupted parenting behavior and attachment disorganization: The role of parental withdrawal / Heather A. YARGER in Development and Psychopathology, 32-3 (August 2020)
[article]
Titre : Intervening with Attachment and Biobehavioral Catch-Up to decrease disrupted parenting behavior and attachment disorganization: The role of parental withdrawal Type de document : Texte imprimé et/ou numérique Auteurs : Heather A. YARGER, Auteur ; Elisa BRONFMAN, Auteur ; Elizabeth A. CARLSON, Auteur ; Mary DOZIER, Auteur Article en page(s) : p.1139-1148 Langues : Anglais (eng) Mots-clés : attachment disrupted parenting behavior intervention parenting withdrawal Index. décimale : PER Périodiques Résumé : This randomized controlled trial investigated the efficacy of Attachment and Biobehavioral Catch-up (ABC; Dozier, Bick, & Bernard, 2011) in reducing disrupted parenting behavior (affective communication errors, role/boundary confusion, fearful/disoriented, intrusive/negativity, and withdrawal) and its association with disorganized attachment. Participants were 105 mother-child dyads randomized to receive either ABC or a control intervention (a 10-session home-visiting intervention focused on improving children's cognitive abilities, gross and fine motor abilities, and language development). At the time of study enrollment, mothers were approximately 26.7 years old (SD = 7.8) and predominantly Black or African American (73.9%). At the first follow-up visit, children were approximately 20.7 months old (SD = 6.3) and most were identified as Black or African American (61.9%). Fifty-two percent of children were male (n = 55). Assessments of disrupted parenting behavior and child attachment quality were assessed approximately 7 months postintervention (SD = 5.8). A one-way analysis of variance revealed that parents who received ABC demonstrated lower levels of parental withdrawal than parents who received the control condition. A structural equation model revealed a significant indirect effect of intervention group on attachment quality through lower levels of parental withdrawal. Results add to the efficacy of the ABC intervention and identified parental withdrawal as a mediator of change. En ligne : http://dx.doi.org/10.1017/s0954579419000786 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=430
in Development and Psychopathology > 32-3 (August 2020) . - p.1139-1148[article] Intervening with Attachment and Biobehavioral Catch-Up to decrease disrupted parenting behavior and attachment disorganization: The role of parental withdrawal [Texte imprimé et/ou numérique] / Heather A. YARGER, Auteur ; Elisa BRONFMAN, Auteur ; Elizabeth A. CARLSON, Auteur ; Mary DOZIER, Auteur . - p.1139-1148.
Langues : Anglais (eng)
in Development and Psychopathology > 32-3 (August 2020) . - p.1139-1148
Mots-clés : attachment disrupted parenting behavior intervention parenting withdrawal Index. décimale : PER Périodiques Résumé : This randomized controlled trial investigated the efficacy of Attachment and Biobehavioral Catch-up (ABC; Dozier, Bick, & Bernard, 2011) in reducing disrupted parenting behavior (affective communication errors, role/boundary confusion, fearful/disoriented, intrusive/negativity, and withdrawal) and its association with disorganized attachment. Participants were 105 mother-child dyads randomized to receive either ABC or a control intervention (a 10-session home-visiting intervention focused on improving children's cognitive abilities, gross and fine motor abilities, and language development). At the time of study enrollment, mothers were approximately 26.7 years old (SD = 7.8) and predominantly Black or African American (73.9%). At the first follow-up visit, children were approximately 20.7 months old (SD = 6.3) and most were identified as Black or African American (61.9%). Fifty-two percent of children were male (n = 55). Assessments of disrupted parenting behavior and child attachment quality were assessed approximately 7 months postintervention (SD = 5.8). A one-way analysis of variance revealed that parents who received ABC demonstrated lower levels of parental withdrawal than parents who received the control condition. A structural equation model revealed a significant indirect effect of intervention group on attachment quality through lower levels of parental withdrawal. Results add to the efficacy of the ABC intervention and identified parental withdrawal as a mediator of change. En ligne : http://dx.doi.org/10.1017/s0954579419000786 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=430 Genetic and maternal predictors of cognitive and behavioral trajectories in females with fragile X syndrome / L. DEL HOYO SORIANO in Journal of Neurodevelopmental Disorders, 10-1 (December 2018)
[article]
Titre : Genetic and maternal predictors of cognitive and behavioral trajectories in females with fragile X syndrome Type de document : Texte imprimé et/ou numérique Auteurs : L. DEL HOYO SORIANO, Auteur ; A. J. THURMAN, Auteur ; D. J. HARVEY, Auteur ; W. Ted BROWN, Auteur ; Leonard ABBEDUTO, Auteur Année de publication : 2018 Article en page(s) : 22 p. Langues : Anglais (eng) Mots-clés : Anxiety Closeness in the mother-child relationship Crystallized intelligence Fmrp Females with FXS Fluid intelligence Longitudinal Maternal psychological distress Ratio of affected to total chromosomes Withdrawal Index. décimale : PER Périodiques Résumé : BACKGROUND: Fragile X syndrome (FXS) is caused by a mutation in the FMR1 gene on the X chromosome, leading to decreased levels of FMR1 protein (FMRP), which causes the array of neuropsychological impairments that define FXS. Because FXS is an X-linked condition, fewer females display FXS and females with FXS are more mildly affected than males, on average. However, there is a considerable variability in terms of severity of affectedness among females with FXS. The current study was designed to investigate potential genetic (FMRP level and ratio of affected to total chromosomes) and environmental factors (maternal psychological distress and closeness in the mother-child relationship) influencing the cognitive (fluid and crystallized intelligence) and behavioral (anxiety and withdrawal) phenotype of females with FXS. METHODS: We conducted a prospective 3-year longitudinal study of 16 females with FXS (with up to four assessments, each separated by a year) using an accelerated longitudinal design so that we had coverage of the age range of 10-15 years at study start and 13-18 at study end. We focused on both the level of functioning related to chronological age expectations (standard scores) and absolute change in skill (raw scores) over the 3-year period. RESULTS: At a cross-sectional level, fluid intelligence and crystallized intelligence were both predicted by a closer mother-child relationship and lower maternal psychological distress. However, only fluid intelligence was predicted by a lower ratio of affected to total chromosomes. Anxiety and withdrawal were predicted by a higher ratio of affected to total chromosomes. Withdrawal was also predicted by lower closeness in the mother-child relationship and higher maternal distress. In terms of longitudinal change, gains were observed in fluid and crystallized intelligence, whereas anxious and withdrawn behaviors remained stable over visits. Gains in fluid intelligence were solely predicted by FXS biomarkers (higher FMRP level and lower ratio of affected to total chromosomes), while gains in crystallized intelligence were not predicted by any of the biological and environmental variables. CONCLUSIONS: Our results show that FXS biomarkers and maternal variables contribute differentially to the cognitive and behavioral features of the adolescent female with FXS. These findings can help in the design of treatment studies aimed at enhancing cognitive and behavioral abilities in the FXS population. En ligne : http://dx.doi.org/10.1186/s11689-018-9240-2 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=386
in Journal of Neurodevelopmental Disorders > 10-1 (December 2018) . - 22 p.[article] Genetic and maternal predictors of cognitive and behavioral trajectories in females with fragile X syndrome [Texte imprimé et/ou numérique] / L. DEL HOYO SORIANO, Auteur ; A. J. THURMAN, Auteur ; D. J. HARVEY, Auteur ; W. Ted BROWN, Auteur ; Leonard ABBEDUTO, Auteur . - 2018 . - 22 p.
Langues : Anglais (eng)
in Journal of Neurodevelopmental Disorders > 10-1 (December 2018) . - 22 p.
Mots-clés : Anxiety Closeness in the mother-child relationship Crystallized intelligence Fmrp Females with FXS Fluid intelligence Longitudinal Maternal psychological distress Ratio of affected to total chromosomes Withdrawal Index. décimale : PER Périodiques Résumé : BACKGROUND: Fragile X syndrome (FXS) is caused by a mutation in the FMR1 gene on the X chromosome, leading to decreased levels of FMR1 protein (FMRP), which causes the array of neuropsychological impairments that define FXS. Because FXS is an X-linked condition, fewer females display FXS and females with FXS are more mildly affected than males, on average. However, there is a considerable variability in terms of severity of affectedness among females with FXS. The current study was designed to investigate potential genetic (FMRP level and ratio of affected to total chromosomes) and environmental factors (maternal psychological distress and closeness in the mother-child relationship) influencing the cognitive (fluid and crystallized intelligence) and behavioral (anxiety and withdrawal) phenotype of females with FXS. METHODS: We conducted a prospective 3-year longitudinal study of 16 females with FXS (with up to four assessments, each separated by a year) using an accelerated longitudinal design so that we had coverage of the age range of 10-15 years at study start and 13-18 at study end. We focused on both the level of functioning related to chronological age expectations (standard scores) and absolute change in skill (raw scores) over the 3-year period. RESULTS: At a cross-sectional level, fluid intelligence and crystallized intelligence were both predicted by a closer mother-child relationship and lower maternal psychological distress. However, only fluid intelligence was predicted by a lower ratio of affected to total chromosomes. Anxiety and withdrawal were predicted by a higher ratio of affected to total chromosomes. Withdrawal was also predicted by lower closeness in the mother-child relationship and higher maternal distress. In terms of longitudinal change, gains were observed in fluid and crystallized intelligence, whereas anxious and withdrawn behaviors remained stable over visits. Gains in fluid intelligence were solely predicted by FXS biomarkers (higher FMRP level and lower ratio of affected to total chromosomes), while gains in crystallized intelligence were not predicted by any of the biological and environmental variables. CONCLUSIONS: Our results show that FXS biomarkers and maternal variables contribute differentially to the cognitive and behavioral features of the adolescent female with FXS. These findings can help in the design of treatment studies aimed at enhancing cognitive and behavioral abilities in the FXS population. En ligne : http://dx.doi.org/10.1186/s11689-018-9240-2 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=386