A randomized controlled trial of a new intervention in early symptomatic syndromes eliciting neurodevelopmental clinical examinations: PR-ESSENCE.

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.

Long-term medication for ADHD and development of cognitive functions in children and adolescents.

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.

Omega 3/6 fatty acids for reading in children: a randomized, double-blind, placebo-controlled trial in 9-year-old mainstream schoolchildren in Sweden.

BACKGROUND: Previous research has shown positive effects of Omega 3/6 fatty acids in children with inattention and reading difficulties. We aimed to investigate if Omega 3/6 improved reading ability in mainstream schoolchildren. METHODS: We performed a 3-month parallel, randomized, double-blind, placebo-controlled trial followed by 3-month active treatment for all subjects. Mainstream schoolchildren aged 9-10 years were randomized 1:1 to receive three Omega 3/6 capsules twice daily or identical placebo. Assessments were made at baseline, 3 months, and 6 months. The primary outcome measure was the Logos test battery for evaluating reading abilities. The trial is registered with ClinicalTrials.gov, number NCT02557477. RESULTS: The study enrolled 154 children (active n = 78; placebo n = 76), of whom 122 completed the first 3 months (active n = 64; placebo n = 58) and 105 completed the whole study (active/active n = 55; placebo/active n = 50). Outcomes were assessed by per protocol (PP) and intention-to-treat (ITT) analyses. Active treatment was superior to placebo at 3 months for improvement in phonologic decoding time (PP active/placebo difference -0.16; 95% CI -0.03, -0.29; effect size (ES) .44; p = .005; and ITT ES .37; p = .036), in visual analysis time (PP active/placebo difference -0.19; 95% CI -0.05, -0.33; ES .49; p = .013; and ITT ES .40; p = .01), and for boys in phonologic decoding time (PP -0.22; 95% CI -0.03, -0.41; ES .62; p = .004). Children with ADHD-RS scores above the median showed treatment benefits in visual analysis time (PP ES .8, p = .009), reading speed per word (PP ES .61, p = .008), and phonologic decoding time per word (PP ES .85, p = .006). Adverse events were rare and mild, mainly stomach pain/diarrhea (active n = 9, placebo n = 2). CONCLUSIONS: Compared with placebo, 3 months of Omega 3/6 treatment improved reading ability - specifically the clinically relevant 'phonologic decoding time' and 'visual analysis time' - in mainstream schoolchildren. In particular, children with attention problems showed treatment benefits.

Fatty acids in ADHD: plasma profiles in a placebo-controlled study of Omega 3/6 fatty acids in children and adolescents.

The aim of this study was to assess baseline levels and changes in plasma fatty acid profiles in children and adolescents with ADHD, in a placebo-controlled study with Omega 3/6 supplementation, and to compare with treatment response. Seventy-five children and adolescents aged 8-18 years with DSM-IV ADHD were randomized to 3 months of Omega 3/6 (Equazen eye q) or placebo, followed by 3 months of open phase Omega 3/6 for all. n-3, n-6, n-6/n-3 ratio, EPA and DHA in plasma were measured at baseline, 3 and 6 months. Subjects with more than 25 % reduction in ADHD symptoms were classified as responders. At baseline, no significant differences in mean fatty acid levels were seen across active/placebo groups or responder/non-responder groups. The 0-3 month changes in all parameters were significantly greater in the active group (p < 0.01). Compared to non-responders, the 6-month responders had significantly greater n-3 increase at 3 months and decrease in n-6/n-3 ratio at 3 and 6 months (p < 0.05). Omega 3/6 supplementation had a clear impact on fatty acid composition of plasma phosphatidyl choline in active versus placebo group, and the fatty acid changes appear to be associated with treatment response. The most pronounced and long-lasting changes for treatment responders compared to non-responders were in the n-6/n-3 ratio.

Attention-deficit/hyperactivity disorder with oppositional defiant disorder in Swedish children - an open study of collaborative problem solving.

AIM: To evaluate collaborative problem solving (CPS) in Swedish 6-13-year-old children with attention-deficit/hyperactivity disorder and oppositional defiant disorder (ODD). METHODS: Seventeen families completed 6-10 sessions of CPS training. Primary outcome measures were SNAP-IV [attention-deficit/hyperactivity disorder (ADHD) and ODD scores] and Clinical Global Impression-Improvement (CGI-I) scores at baseline, post-intervention and 6 months later. Secondary outcome measures were the Conners' 10-item scale and the Family Burden of Illness Module (FBIM). RESULTS: All 17 participants completed the intervention. The whole group had significant reductions in SNAP-IV ODD, ADHD, total Conners' and FBIM scores, both at post-intervention and at 6-month follow-up. Eight of the children, although significantly improved on ODD scores and the Conners' emotional lability subscale at post-intervention, had almost no improvement in hyperactivity/impulsivity. Post-intervention, this group received stimulant medication for their ADHD. CGI-I scores of much improved or very much improved were reached by 53% (9/17) of all at post-intervention, and by 81% (13/16) at 6-month follow-up. CONCLUSION: Collaborative problem solving significantly reduced ODD, ADHD and emotional lability symptoms. A subgroup improved in their ADHD symptoms only after adding stimulant medication.

Omega-3/omega-6 fatty acids for attention deficit hyperactivity disorder: a randomized placebo-controlled trial in children and adolescents.

OBJECTIVE: The aim of the study was to assess omega 3/6 fatty acids (eye q) in attention deficit hyperactivity disorder (ADHD). METHOD: The study included a randomized, 3-month, omega 3/6 placebo-controlled, one-way crossover trial with 75 children and adolescents (8-18 years), followed by 3 months with omega 3/6 for all. Investigator-rated ADHD Rating Scale-IV and Clinical Global Impression (CGI) scale were outcome measures. RESULTS: A majority did not respond to omega 3/6 treatment. However, a subgroup of 26% responded with more than 25% reduction of ADHD symptoms and a drop of CGI scores to the near-normal range. After 6 months, 47% of all showed such improvement. Responders tended to have ADHD inattentive subtype and comorbid neurodevelopmental disorders. CONCLUSION: A subgroup of children and adolescents with ADHD, characterized by inattention and associated neurodevelopmental disorders, treated with omega 3/6 fatty acids for 6 months responded with meaningful reduction of ADHD symptoms.