ABSTRACT
The need for effective intervention programs for youth with neurodevelopmental problems (ESSENCE) and challenging behaviour is great. This study examines Problem Resolution in ESSENCE (PR-ESSENCE), a newly developed model in which children and parents develop mutual problem resolution strategies. Ten-week randomized controlled trial of PR-ESSENCE for children and adolescents aged 5-18 years, compared to treatment as usual. Outcomes were assessed at baseline and randomized period endpoint. Primary outcome was the Clinical Global Impression-Improvement scale (CGI-I) rated by blinded assessors. Secondary outcomes were rated by parents-SNAP-IV, Eyberg Child Behavior Inventory (ECBI), Relationship Problems Questionnaire, Family Burden of Illness Module, and children-Beck Youth Inventories (BYI). ClinicalTrials.gov identifier: NCT03780413. The study enrolled 108 participants (active n = 72; controls n = 36, randomized 2:1), of whom 95 completed the randomized period. No clinically significant group differences were found in baseline characteristics. More than half had autism and 80% had ADD or ADHD. Large treatment effects were seen on CGI-I (ITT analysis, Effect Size 1.48). Treatment responders, much/very much improved on CGI-I, were 51.4% in active group and 5.6% of controls. Effect sizes were medium to large in parent ratings on SNAP-IV (ODD and ADHD symptoms), ECBI (behaviour problems), and in BYI child self-ratings of disruptive behaviour. PR-ESSENCE treatment improved global symptoms and functioning (CGI-I), behaviour problems, ADHD and ODD symptoms, and disruptive behaviour. Treatment effects were at least equivalent to those in previous studies of well-established Parent Management Training and Collaborative Problem Solving programs.
Subject(s)
Attention Deficit Disorder with Hyperactivity , Problem Behavior , Child , Adolescent , Humans , Attention Deficit Disorder with Hyperactivity/diagnosis , Parents/education , Child Behavior , Surveys and Questionnaires , Treatment OutcomeABSTRACT
BACKGROUND: Treatment with intravenous immunoglobulin (IVIG) in children with Paediatric Acute-onset Neuropsychiatric Syndrome (PANS) has for many years been used on clinical indications, but the research evidence for its efficacy is insufficient. METHODS: Open-label prospective in-depth trial including ten children (median age 10.3 years) with PANS, who received IVIG treatment 2 g/kg monthly for three months. Primary outcomes were changes in symptom severity and impairment from baseline to first and second follow-up visits one month after first and one month after third treatment, using three investigator-rated scales: Paediatric Acute Neuropsychiatric Symptom (PANS) scale, Clinical Global Impression - Severity and Improvement (CGI-S and CGI-I) scales. Secondary outcomes reported here were changes in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) scores, and side effects. RESULTS: All ten children received three treatments at one-month intervals according to study plan. From baseline to second follow-up marked reductions were seen in mean total PANS scale scores (p = .005), and CGI-S scores (p = .004). CGI-I ratings showed much to very much global improvement (mean CGI-I 1.8). Nine children had clinical response defined as > 30% reduction in PANS Scale scores. Improvements were also noted for CY-BOCS scores (p = .005), and in school attendance. Three children suffered moderate to severe temporary side effects after the first treatment, and the remaining seven had mild to moderate side effects. Side effects were much less severe after second and third treatments. CONCLUSIONS: Considerable and pervasive improvements in symptoms and clinical impairments were seen in these ten children after three monthly IVIG treatments. Moderate to severe transient side effects occurred in three cases. TRIAL REGISTRATION: EudraCT no. 2019-004758-27, Clinicaltrials.gov no. NCT04609761, 05/10/2020.
Subject(s)
Autoimmune Diseases , Obsessive-Compulsive Disorder , Autoimmune Diseases/diagnosis , Autoimmune Diseases/drug therapy , Child , Humans , Immunoglobulins, Intravenous/therapeutic use , Obsessive-Compulsive Disorder/diagnosis , Obsessive-Compulsive Disorder/drug therapy , Prospective StudiesABSTRACT
OBJECTIVE: Long-term effects of ADHD medication on cognitive functions are not well known. This study investigates development of cognitive functions and ADHD symptoms on well-controlled medication for 1 year in children and adolescents. STUDY DESIGN: This study is part of an ongoing open uncontrolled trial of long-term medication for ADHD in children and adolescents aged 6-18 years with any form of ADHD, and frequently comorbid autism spectrum disorder (ASD, 29%) or autistic traits (24%). Other comorbidities were oppositional defiant disorder, dyslexia/language disorder, borderline intellectual functioning, developmental coordination disorder. This analysis includes 87 participants (61 boys, 26 girls) who completed Wechsler tests at baseline and after 12 months. ADHD symptoms were investigator-rated on the ADHD Rating Scale-IV at the same time points. RESULTS: The whole group of children and adolescents showed significant improvements in Wechsler Full Scale IQ (FSIQ, mean at baseline 92.6, at 12 months 97.95), and on the Index Scales Verbal Comprehension, Working Memory and Processing Speed, after one year of well-controlled ADHD medication. Comorbid dyslexia/language impairment predicted a larger rise in FSIQ, but not gender, ADHD presentation or comorbid ASD. Robust improvements in ADHD symptoms were observed (mean ADHD-Rating Scale score at baseline 34.6, and at 12 months 18.3). CONCLUSIONS: Cognitive test scores and ADHD symptoms were improved on well-controlled medication for 1 year in children and adolescents with ADHD, autism and other comorbidities. The main study limitation is the open uncontrolled trial design.
