Seizure frequency, quality of life, behavior, cognition, and sleep in pediatric patients enrolled in a prospective, open-label clinical study with cannabidiol.

OBJECTIVE: To evaluate the effects of oral pharmacological cannabidiol (CBD) on seizures, side effects, quality of life, behavior, mood, and sleep in children with drug-resistant epilepsy (DRE) during a phase II, prospective, open-label clinical study. METHODS: During a phase II expanded access program (EAP) study to evaluate the safety and efficacy of using cannabidiol (CBD) for the long-term treatment of children with drug-resistant epilepsy, secondary outcome measures were also performed, including quality of life (QOLCE), behavior (aberrant behavior checklist ABC), and sleep (children's sleep habit questionnaire, CSHQ). Participants between the ages of 2 and 16 years of age with drug-resistant epilepsy (n = 35) were included in this EAP. Primary outcomes included change in parent-recorded seizure frequency relative to baseline, as well as the safety and tolerability over the course of 24 months of CBD treatment. Secondary outcomes observed in the first 12 months included changes in child behavior, and cognitive function, and sleep quality. RESULTS: The median change in overall seizure frequency decreased from baseline (n = 33) by -61.3% ([n = 33], Inter Quartile Range (IQR): 43-88%) at month 3, -62.9% at month 6 ([n = 29], IQR: 48-92%), -74.7% at month 12 ([n = 29], IQR: 64-96%), and finally -83.7% ([n = 28], IQR: 68-100%) at the conclusion of 24 months of treatment. Seven (20%) of the 35 patients enrolled withdrew from treatment and observation by month 24: 2 failed inclusion criteria at baseline, 4 due to lack of treatment efficacy, and 1 was lost to follow-up. The 12-month recording of secondary measures revealed a significant improvement in Irritability (-39.4%, [n = 28], ABC), Hyperactivity (-45.4%, [n = 28], ABC), Cognition in Quality of Life (+14.2%, [n = 28], QOLCE), Behavioral function (+14.7%, [n = 28], QOLCE), General Health (+14.7%, [n = 28], QOLCE), Sleep duration (-33.9%, [n = 28], CSHQ), Daytime sleepiness (-23.8%, [n = 28], CSHQ), and nocturnal arousals (-36.2%, [n = 28], CSHQ). SIGNIFICANCE: The results of this phase II open-label study demonstrate that pharmacological CBD significantly reduces seizure frequency, and improves QOL, behavior deficits, and sleep disruption, in children with drug-resistant epilepsy. The results also suggest that CBD is efficacious in controlled seizures over a 2-year period in childhood DRE.

Parent Training for Feeding Problems in Children With Autism Spectrum Disorder: Initial Randomized Trial.

Objective: Many children with autism spectrum disorder (ASD) have feeding and mealtime problems. To address these, we conducted a pilot randomized trial of a new 11-session, individually delivered parent training program that integrated behavioral strategies and nutritional guidance (PT-F). Methods: Forty-two young children (age: 2 to 7-11 years) with ASD and feeding problems were assigned to 11 sessions of PT-F intervention over 20 weeks or a waitlist control. Outcomes included attendance, parent satisfaction, therapist fidelity, and preliminary assessments of child and parent outcomes. Results: Of the 21 PT-F families, attendance was high (85%) as was parent satisfaction (94% would recommend to others). Treatment fidelity was also high (97%-therapist integrity; 94%-parent adherence). Compared with waitlist, children whose parents participated in PT-F showed significantly greater reductions on the two parent-completed primary outcomes (Brief Autism Mealtime Behavior Inventory-Revised; Twald = -2.79; p = .003; About Your Child's Eating; Twald = -3.58; p = .001). On the independent evaluator-completed secondary eating outcome, the Clinical Global Impression-Improvement, 48.8% of the participants in PT-F were rated as "responders" compared with 0% in waitlist (p = .006). General child disruptive behavior outcomes decreased more in PT-F but not significantly. Parent outcomes of caregiver stress showed nonsignificant trends favoring PT-F with moderate to small effect sizes. Conclusions: This trial provides evidence for feasibility, satisfaction, and fidelity of implementation of PT-F for feeding problems in young children with ASD. Feeding outcomes also appeared favorable and lends support for conducting a larger efficacy trial.

Follow-up of telehealth parent training for sleep disturbances in young children with autism spectrum disorder.

OBJECTIVE/BACKGROUND: Bedtime and sleep disturbances are ubiquitous in children with autism. The telehealth delivery of a behavior analytic parent training program was earlier reported to be efficacious in improving child sleep and parent sense of competency. Our aim in this brief report was to determine the durability of the telehealth delivered sleep parent training program (SPT) compared to the control condition in this randomized controlled trial. Telehealth delivery could be a means to expand access to such early treatment if efficacious. PARTICIPANTS/METHODS: Parents of young children, ages 2-7 years, with autism and co-occurring sleep disturbances were enrolled in this study. Participants were randomized to either SPT or a comparison arm that included non-sleep related parent education except for one session Sleep Parent Education; SPE). Each participant was individually administered a 5 session program delivered over 10 weeks. Outcome measures were collected at weeks 5 and 10 and at post-treatment follow-up at 16 weeks. RESULTS: Follow-up week 16 data were available for 30 participants randomized to SPT and 24 participants randomized to SPE. Demographics for this follow-up cohort were similar to the full sample. At week 16 follow-up, there was a significant group difference between SPT and SPE the Modified Simonds & Parraga Sleep Questionnaire-Composite Sleep Index (MSPSQ - CSI) (p = 0.011) with an effect size of 0.68. Further, 8 of the 10 children in SPT who were negative responders at the week 10 endpoint were rated as positive responders at week 16 by the treatment masked IE compared to 2 out of 12 in the SPE group (p = 0.008). CONCLUSIONS: Post-treatment follow-up data suggests SPT is durable over time compared to SPE, the active control group. Further, for some participants in SPT, a positive responsive emerged after the treatment endpoint. This brief report adds to the efficacy of SPT as a time-limited intervention for insomnia in young autistic children.

Telehealth parent training for sleep disturbances in young children with autism spectrum disorder: A randomized controlled trial.

BACKGROUND AND PURPOSE: Young children with autism spectrum disorder (autism) have bedtime and sleep disturbances at much higher frequency and persistency than their neurotypical counterparts. Hence, access to early, effective treatment is critical in view of the importance of sleep in early childhood. Telehealth delivery could be a means to expand access to such early treatment if efficacious. The aim of this randomized control trial (RCT) was to compare a manualized, telehealth delivered, behaviorally based sleep parent training (SPT) intervention for parents of young children with autism and sleep disturbances to a control condition, a telehealth delivered parent education program with one sleep focused session (SPE). We hypothesized that the SPT group would show more improvements on child measures of sleep outcome measures, and daytime behaviors and parent measures of stress and sense of competence. We further aimed to explore the overall feasibility of telehealth delivery of SPT and SPE. PARTICIPANTS AND METHODS: Parents of 77 young children, ages 2-7 years, with autism and co-occurring sleep disturbances were enrolled in this study. Participants were randomized to either SPT or a comparison arm that included non-sleep related parent education except for one session. Each participant was individually administered a 5 session program delivered over 10 weeks. Outcome measures, including child sleep measures, child daytime behavior and parent stress and sense of competency were collected at weeks 5 and 10 after the baseline time point. Feasibility indicators (treatment fidelity, parent adherence, and parent attendance), and safety measures were also collected. RESULTS: Of 77 randomized participants, data were available for 36 participants randomized to SPT and 38 participants randomized to SPE. The mean age was 3 years, 8 months. Results support the efficacy of this manualized SPT intervention for bedtime and sleep disturbances. Sleep outcome measures were significantly improved in the SPT group compared to SPE on the Modified Simonds & Parraga Sleep Questionnaire-Composite Sleep Index (MSPSQ - CSI) (p < 0.001) with a large effect size of 0.83 at week 10. Positive response to treatment, as determined from the Clinical Global Impression-Improvement scale (CGI-I) at week 10 was observed in 56% of SPT participants compared to 32% in SPE (p = 0.037). There were no significant group differences in either the ABC-I as measure of daytime behaviors or in parental stress. There were group differences in favor of SPT over SPE on the PSOC, a measure of parent sense of competency. Feasibility and safety were further demonstrated with telehealth delivery. CONCLUSIONS: This RCT demonstrated the efficacy of a telehealth delivered parent training intervention for bedtime and sleep disturbances in young autistic children compared to an active control condition. Further, parents in SPT reported more confidence in their parenting role than those in the SPE group, but SPT did not result in overall decreases in parental stress. Telehealth delivery allowed for a much broader reach with enrolled participants from 24 states. This study supports a telehealth approach to a manualized behavioral parent mediated intervention for sleep disturbance in young autistic children and offers an alternative to in-person delivered approaches. This telehealth delivery has the potential to improve access for families who have a young autistic child with sleep disturbances. Given the small sample size, determining predictors and moderators of treatment response was not possible and should be examined in a larger trial.

Using Parent Target Problem Narratives to Evaluate Outcomes in Children with Autism Spectrum Disorder.

This paper examines the reliability and validity of parent target problems (PTPs) in a multi-site randomized controlled trial of parent training (PT) versus psychoeducation (PEP) in children (150 boys, 19 girls; mean age 4.7 ± 1.2 years) with autism spectrum disorder (ASD) and disruptive behavior. At baseline, treatment blind, independent evaluators asked parents to nominate the child's top two problems. Each problem was documented in a brief narrative. Narratives were reviewed and revised at follow-up visits during the six-month trial. When the trial was completed, five judges, blind to treatment condition, independently rated change from baseline on a 9-point scale (1 = normal; 2 = markedly improved; 3 = definitely improved; 4 = equivocally improved; 5 = no change; 6 = possibly worse; 7 = definitely worse; 8 = markedly worse; 9 = disastrously worse) at Weeks 8, 12, 16, and 24 (inter-rater intraclass correlation = 0.78). PTP scores for the two target problems were averaged across the five raters, yielding a mean score for each child at each time point. Mean PTP scores showed improvement in both treatment groups over the 24-week study. Compared to PEP, PTP ratings showed a steeper decline in PT based on significant interaction of group and time (t(df) = 2.14(155.9), p = 0.034; Week 24 effect size = 0.75). In categorical analysis, we compared cutoffs mean PTP scores of 3.0 (definitely improved), 3.25, and 3.5 with the positive response rate on the Clinical Global Impressions-Improvement scale from the original study. Sensitivities ranged from 52-78%. PTP narratives offer a systematic, reliable, and valid way to track child-specific outcomes in clinical trials and clinical practice.

Predictors of Caregiver Strain for Parents of Children with Autism Spectrum Disorder.

Parents of children with autism spectrum disorder (ASD) face higher levels of caregiver strain compared to parents of children with other disabilities. This study examined child clinical features that predict high levels of caregiver strain for 374 parents of children with ASD. Caregiver strain was measured using the Caregiver Strain Questionnaire (CGSQ) objective, subjective internalized, and subjective externalized subscales. Confirmatory factor analysis indicated an acceptable fit for the original CGSQ three-factor solution. The strongest child predictors across CGSQ subscales were: disruptive behavior for objective strain, autism severity and disruptive behavior for subjective internalized strain, and oppositional behavior and hyperactivity for subjective externalized strain. Individualized interventions that attend to specific elements of parental strain may reduce strain and improve family wellbeing.

Standardised Observation Analogue Procedure (SOAP) for assessing parent and child behaviours in clinical trials.

BACKGROUND: Observational measures of parent and child behaviours have a long history in child psychiatric and psychological intervention research, including the field of autism and developmental disability. We describe the development of the Standardised Observational Analogue Procedure (SOAP) for the assessment of parent-child behaviour before and after a structured parent training program for children with pervasive developmental disorders (PDD). We report on the use of this procedure in a pilot study of 12 participants with PDD. RESULTS: Inter-rater reliability across behaviours coded ranged from 75-100% agreement. Blindly scored observations of behaviour showed medium effect sizes for changes in inappropriate child behaviour. Analyses of baseline scores revealed a moderate positive correlation between inappropriate child behaviours as measured in all four SOAP conditions and parent ratings of child noncompliance (r(s) = .66, p < .05). By contrast, the correlations of SOAP scores with parent ratings of irritability was lower (r(s) = .40, p >.05). CONCLUSIONS: As our treatment targeted compliance, these preliminary results suggest that the SOAP provides a valid measure of noncompliant behaviour in children with PDD and is sensitive to treatment effects on inappropriate child behaviours.

Exploring sleep quality of young children with autism spectrum disorder and disruptive behaviors.

BACKGROUND AND PURPOSE: Sleep disturbances in autism spectrum disorder (ASD) are common and may impair daytime functioning as well as add to parental burden. In this well characterized sample of young children with ASD and disruptive behaviors, we examine the association of age and IQ in sleep disturbances using the Child Sleep Habits Questionnaire modified for ASD (CSHQ-ASD). We also test whether children with poor sleep have greater daytime behavioral problems than those with better sleep. Finally, we examine whether parental stress is higher in children with greater disruptive behaviors and sleep disturbances. PARTICIPANTS AND METHODS: One hundred and seventy-seven children with complete data out of 180 (mean age 4.7) with ASD participated in a randomized clinical trial. Parents completed the CSHQ-ASD and several other measures at study enrollment. The sample was divided into "poor sleepers" (upper quartile on the total score of the CSHQ-ASD) and "good sleepers" (lower quartile) for comparisons. Analyses were conducted to evaluate group differences on age, IQ, daytime disruptive behavior, social disability and parental stress. RESULTS: The two groups of young children with ASD, good sleepers versus poor sleepers, were not different on age or cognitive level. Children in the poor sleeping group had significantly higher daytime behavioral problems including irritability, hyperactivity, social withdrawal and stereotypical behaviors. Parents in this group reported significantly higher levels of stress. CONCLUSIONS: The finding of no age difference between good and poor sleepers in young children with ASD and disruptive behaviors suggests that sleep problems are unlikely to resolve as might be expected in typically developing children. Likewise, the good and poor sleepers did not significantly differ in IQ. These findings add strong support for the need to screen for sleep disturbances in all children with ASD, regardless of age and cognitive level. Poor sleepers exhibited significantly greater daytime behavioral problems and parents of children in this group reported significantly higher levels of stress. Above and beyond the co-occurring disruptive behavior, poor sleep quality appears to pose substantial additive burden on child and parents.

Modification of the Children's Sleep Habits Questionnaire for Children with Autism Spectrum Disorder.

Sleep problems are common in children with autism spectrum disorder (ASD) and adversely impact daytime functioning. Although no questionnaires have been developed to assess sleep in children with ASD, the 33-item Children's Sleep Habits Questionnaire (CSHQ) is widely used in this population. We examined the factor structure of the CSHQ in 2872 children (age 4-10 years) enrolled in the Autism Treatment Network. A four-factor solution (Sleep Initiation and Duration, Sleep Anxiety/Co-Sleeping, Night Waking/Parasomnias, and Daytime Alertness) with 5-6 items per factor explained 75% of the total variation. Ten items failed to load on any factor. This abbreviated 23-item four-factor version of this measure may be useful when assessing sleep in children with ASD.

Developmental disabilities modification of the Children's Global Assessment Scale.

BACKGROUND: Interventions for pervasive developmental disorders (PDD) aim to alleviate symptoms and improve functioning. To measure global functioning in treatment studies, the Children's Global Assessment Scale was modified and psychometric properties of the revised version (DD-CGAS) were assessed in children with PDD. METHODS: Developmental disabilities-relevant descriptors were developed for the DD-CGAS, and administration procedures were established to enhance rater consistency. Ratings of clinical case vignettes were used to assess inter-rater reliability and temporal stability. Validity was assessed by correlating the DD-CGAS with measures of functioning and symptoms in 83 youngsters with PDD. Sensitivity to change was assessed by comparing change from baseline to post-treatment with change on the Aberrant Behavior Checklist-Irritability and Clinical Global Impressions-Improvement subscale scores in a subset of 14 children. RESULTS: Inter-rater reliability (intraclass correlation coefficient [ICC] = .79) and temporal stability (average ICC = .86) were excellent. The DD-CGAS scores correlated with measures of functioning and symptoms with moderate to large effect sizes. Changes on the DD-CGAS correlated with changes on the Aberrant Behavior Checklist-I (r = -.71) and Global Impressions Scale-I (r = -.52). The pre-post DD-CGAS change had an effect size of .72. CONCLUSIONS: The DD-CGAS is a reliable instrument with apparent convergent validity for measuring global functioning of children with PDD in treatment studies.

Psychometric properties of the children's sleep habits questionnaire in children with autism spectrum disorder.

BACKGROUND AND PURPOSE: Sleep disturbances in autism spectrum disorder (ASD) are very common. Psychometrically sound instruments are essential to assess these disturbances. Children's Sleep Habit Questionnaire (CSHQ) is a widely used measure in ASD. The purpose of this study was to explore the psychometric properties of the CSHQ in a sample of children with ASD. PARTICIPANTS AND METHODS: Parents/caregivers of 310 children (mean age: 4.7) with ASD completed the CSHQ at study enrollment. Correlations between intelligence quotient (IQ) scores and the original CSHQ scales were calculated. Item endorsement frequencies and percentages were also calculated. A principal component analysis (PCA) was performed, and internal consistency was assessed for the newly extracted components. RESULTS: Correlations between IQ scores and CSHQ subscales and total scores ranged from .015 to .001 suggesting a weak, if any, association. Item endorsement frequencies were high for bedtime resistance items, but lower for parasomnia and sleep-disordered breathing items. A PCA suggested that a five-component solution best fits the data. Internal consistency of the newly extracted five components ranged α = .87-.50. CONCLUSIONS: Item endorsement frequencies were highest for bedtime resistance items. A PCA suggested a five-component solution. Three of the five components (Sleep Routine Problems, Insufficient Sleep, and Sleep-onset Association Problems) were types of sleep disturbances commonly reported in ASD, but the other two components (Parasomnia/Sleep-disordered Breathing and Sleep Anxiety) were less clear. Internal consistencies ranged from mediocre to good. Further development of this measure for use in children with ASD is encouraged.

Dietary Supplementation in Children with Autism Spectrum Disorders: Common, Insufficient, and Excessive.

BACKGROUND: Little is known about the effect on dietary adequacy of supplements given to children with autism spectrum disorder (ASD). OBJECTIVE: This cross-sectional study examines dietary supplement use and micronutrient intake in children with ASD. DESIGN: Three-day diet/supplement records and use of a gluten/casein-free diet (GFCF) were documented. Estimates of usual intake of micronutrients from food and supplements were compared with the Dietary Reference Intakes. PARTICIPANTS: Children aged 2 to 11 years (N=288) with ASD from five Autism Treatment Network sites from 2009-2011. MAIN OUTCOME MEASURES: Percentage of children meeting or exceeding upper limits of micronutrient intake with or without supplements and relative to GFCF diet status. STATISTICAL ANALYSIS: Micronutrient intake from food and supplements was compared by Spearman rank correlation. Usual intake was estimated by the National Cancer Institute method adjusted for age, sex, supplement use, and GFCF diet. Adequacy of intake was compared between supplement use status and between food and total intake in supplement users relative to Dietary Reference Intakes limits. RESULTS: Dietary supplements, especially multivitamin/minerals, were used by 56% of children with ASD. The most common micronutrient deficits were not corrected (vitamin D, calcium, potassium, pantothenic acid, and choline) by supplements. Almost one-third of children remained deficient for vitamin D and up to 54% for calcium. Children receiving GFCF diets had similar micronutrient intake but were more likely to use supplements (78% vs 56%; P=0.01). Supplementation led to excess vitamin A, folate, and zinc intake across the sample, vitamin C, and copper among children aged 2 to 3 years, and manganese and copper for children aged 4 to 8 years. CONCLUSIONS: Few children with ASD need most of the micronutrients they are commonly given as supplements, which often leads to excess intake. Even when supplements are used, careful attention should be given to adequacy of vitamin D and calcium intake.

Relationships between feeding problems, behavioral characteristics and nutritional quality in children with ASD.

Many children with autism spectrum disorders (ASD) have co-occurring feeding problems. However, there is limited knowledge about how these feeding habits are related to other behavioral characteristics ubiqitious in ASD. In a relatively large sample of 256 children with ASD, ages 2-11, we examined the relationships between feeding and mealtime behaviors and social, communication, and cognitive levels as well repetitive and ritualistic behaviors, sensory behaviors, and externalizing and internalizing behaviors. Finally, we examined whether feeding habits were predictive of nutritional adequacy. In this sample, we found strong associations between parent reported feeding habits and (1) repetitive and ritualistic behaviors, (2) sensory features, and (3) externalizing and internalizing behavior. There was a lack of association between feeding behaviors and the social and communication deficits of ASD and cognitive levels. Increases in the degree of problematic feeding behaviors predicted decrements in nutritional adequacy.

Behavioral parent training to address sleep disturbances in young children with autism spectrum disorder: a pilot trial.

OBJECTIVES: A large percentage of children with autism spectrum disorders (ASD) have bedtime and sleep disturbances. However, the treatment of these disturbances has been understudied. The purpose of our study was to develop a manualized behavioral parent training (BPT) program for parents of young children with ASD and sleep disturbances and to test the feasibility, fidelity, and initial efficacy of the treatment in a small randomized controlled trial (RCT). PARTICIPANTS AND METHODS: Parents of a sample of 40 young children diagnosed with ASD with an average age of 3.5years were enrolled in our study. Participants were randomized to either the BPT program group or a comparison group who were given nonsleep-related parent education. Each participant was individually administered a 5-session program delivered over the 8-week study. Outcome measures of feasibility, fidelity, and efficacy were collected at weeks 4 and 8 after the baseline time point. Children's sleep was assessed by parent report and objectively by actigraphy. RESULTS: Of the 20 participants in each group, data were available for 15 participants randomized to BPT and 18 participants randomized to the comparison condition. Results supported the feasibility of the manualized parent training program and the comparison program. Treatment fidelity was high for both groups. The BPT program group significantly improved more than the comparison group based on the primary sleep outcome of parent report. There were no objective changes in sleep detected by actigraphy. CONCLUSIONS: Our study is one of few RCTs of a BPT program to specifically target sleep disturbances in a well-characterized sample of young children with ASD and to demonstrate the feasibility of the approach. Initial efficacy favored the BPT program over the comparison group and suggested that this manualized parent training approach is worthy of further examination of the efficacy within a larger RCT.

Use of a Direct Observational Measure in a Trial of Risperidone and Parent Training in Children with Pervasive Developmental Disorders.

A Structured Observational Analog Procedure (SOAP), an analogue measure of parent-child interactions, was used to assess treatment outcome in children with Autism Spectrum Disorder and serious behavior problems. It served as a secondary outcome measure in a 24-week, randomized trial of risperidone (MED; N=49) versus risperidone plus parent training (COMB; n=75) (ages 4-13 years). At 24-weeks, there was 28 % reduction in child inappropriate behavior during a Demand Condition (p=.0002) and 12 % increase in compliance to parental requests (p=.004) for the two treatment conditions combined. Parents displayed 64 % greater use of positive reinforcement (p=.001) and fewer repeated requests for compliance (p<.0001). In the analysis of covariance (ANCOVA), COMB parents used significantly more positive reinforcement (p=.01) and fewer restrictive statements (p<.05) than MED parents. The SOAP is sensitive to change in child and parent behavior as a function of risperidone alone and in combination with PMT and can serve as a valuable complement to parent and clinician-based measures.

Comparison of sleep questionnaires in the assessment of sleep disturbances in children with autism spectrum disorders.

BACKGROUND AND PURPOSE: The purpose of this study was to compare two parent completed questionnaires, the Modified Simonds & Parraga Sleep Questionnaire (MSPSQ) and the Children's Sleep Habits Questionnaire (CSHQ), used to characterize sleep disturbances in young children with autism spectrum disorders (ASD). Both questionnaires have been used in previous work in the assessment and treatment of children with ASD and sleep disturbance. PARTICIPANTS AND METHODS: Parents/caregivers of a sample of 124 children diagnosed with ASD with an average age of six years completed both sleep questionnaires regarding children's sleep behaviors. Internal consistency of the items for both measures was evaluated as well as the correlation between the two sleep measures. A Receiver Operating Characteristics (ROC) curve analysis was also conducted to examine the predictive power of the MSPSQ. RESULTS: More than three quarters of the sample (78%) were identified as poor sleepers on the CSHQ. Cronbach's alpha for the items on the CSHQ was 0.68 and Cronbach's alpha for items on the MSPSQ was 0.67. The total scores for MSPSQ and CSHQ were significantly correlated (r=.70, p<.01). After first identifying the poor sleepers based on the CSHQ, an area under the curve was 0.89 for the MSPSQ. Using a cut off score of 56 on the MSPSQ, sensitivity was .86 and specificity was .70. CONCLUSIONS: In this sample of children with ASD, sleep disturbances were common across all cognitive levels. Preliminary findings suggest that, similar to the CSHQ, the MSPSQ has adequate internal consistency. The two measures were also highly correlated. A preliminary cut off of 56 on the MSPSQ offers high sensitivity and specificity commensurate with the widely used CSHQ.

Predictors and moderators of parent training efficacy in a sample of children with autism spectrum disorders and serious behavioral problems.

The Research Units on Pediatric Psychopharmacology--Autism Network reported additional benefit when adding parent training (PT) to antipsychotic medication in children with autism spectrum disorders and serious behavior problems. The intent-to-treat analyses were rerun with putative predictors and moderators. The Home Situations Questionnaire (HSQ) and the Hyperactivity/Noncompliance subscale of the Aberrant Behavior Checklist were used as outcome measures. Candidate predictors and moderators included 21 demographics and baseline measures of behavior. Higher baseline HSQ scores predicted greater improvement on the HSQ regardless of treatment assignment, but no other predictors of outcome were observed. None of the variables measured in this study moderated response to PT. Antipsychotic medication plus PT appears to be equally effective for children with a wide range of demographic and behavioral characteristics.

Safety and efficacy of donepezil in children and adolescents with autism: neuropsychological measures.

OBJECTIVE: There has been recent interest in the use of cognitive enhancing drugs, such as cholinesterase inhibitors, as a possible treatment for executive functioning (EF) deficits in autism spectrum disorder (ASD). The goal of this study was to assess the tolerability, safety, and efficacy of donepezil on EF in a sample of children and adolescents with ASD. METHOD: Thirty-four children and adolescents with ASD (age range 8-17 years; IQ >75) were enrolled in a 10-week, double-blind, placebo-controlled trial of donepezil (doses of 5 and 10 mg), followed by a 10-week open label trial for placebo nonresponders. RESULTS: The effect of donepezil treatment on EF was examined. Despite improvement on a number of EF measures, no statistically significant between-group differences were found (with gains observed for both the placebo and donepezil groups). CONCLUSIONS: The results suggest that short-term treatment with donepezil may have limited impact on cognitive functioning in ASD. Future controlled trials may need to consider a longer treatment period to detect significant gains on EF measures.

Development of a cognitive-behavioral intervention program to treat anxiety and social deficits in teens with high-functioning autism.

Anxiety is a common co-occurring problem among young people with autism spectrum disorders (ASD). Characterized by deficits in social interaction, communication problems, and stereotyped behavior and restricted interests, this group of disorders is more prevalent than previously realized. When present, anxiety may compound the social deficits of young people with ASD. Given the additional disability and common co-occurrence of anxiety in ASD, we developed a manual-based cognitive-behavioral treatment program to target anxiety symptoms as well as social skill deficits in adolescents with ASD [Multimodal Anxiety and Social Skills Intervention: MASSI]. In this paper, we describe the foundation, content, and development of MASSI. We also summarize data on treatment feasibility based on a pilot study that implemented the intervention.