Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol.
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ABSTRACT: Introduction
Intervention in the preschool period is currently recommended for autism spectrum disorder. Therapies delivered by parents are particularly suitable for young children. Preschool Autism Communication Trial (PACT) is a parent-mediated therapy that has shown a significant and sustained impact on autism symptom reduction. However, access to such evidence-based therapies for families is limited due to autism centres located in large urban areas. Using videoconferencing to deliver PACT training to parents may improve accessibility for families living in underserved areas.Methods and analysis
This single-blind randomised controlled trial, involving six sites in France, will investigate the efficacy of a telehealth, videoconferencing-based, parent-mediated PACT therapy on autism symptoms, over a 12-month period. It will compare PACT plus treatment as usual (TAU) against TAU only in a cohort of 238 toddlers (119 per group) aged 18-36 months at inclusion and living with their families more than 40 min away from the specialist centres for autism. Primary outcome will include change of overall autism score on the Autism Diagnostic Observation Scale (ADOS) at 12 months. Secondary outcomes will measure change in child skills, child functioning, impact on parents (stress, health, priorities) and implementation characteristics. Repeated measures analyses will be used to test the effect of PACT intervention on the overall ADOS module 1 score over the 12-month study period. Linear mixed models will be used with time, treatment allocation and the interaction between treatment and time as fixed effects and individual variation as random effect.Ethics and dissemination
This protocol (V.5, date: 25 October 2019) is approved by the French National Review Board (reference no 2018-A02516-49). The results will be disseminated via peer-reviewed journals TRIAL REGISTRATION NUMBER: NCT04244721.
SUBMITTER: Jurek L
PROVIDER: S-EPMC8031029 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Results of small trials suggest that early interventions for social communication are effective for the treatment of autism in children. We therefore investigated the efficacy of such an intervention in a larger trial.Children with core autism (aged 2 years to 4 years and 11 months) were randomly assigned in a one-to-one ratio to a parent-mediated communication-focused (Preschool Autism Communication Trial [PACT]) intervention or treatment as usual at three specialist centres in the UK. Those assigned to PACT were also given treatment as usual. Randomisation was by use of minimisation of probability in the marginal distribution of treatment centre, age (</=42 months or >42 months), and autism severity (Autism Diagnostic Observation Schedule-Generic [ADOS-G] algorithm score 12-17 or 18-24). Primary outcome was severity of autism symptoms (a total score of social communication algorithm items from ADOS-G, higher score indicating greater severity) at 13 months. Complementary secondary outcomes were measures of parent-child interaction, child language, and adaptive functioning in school. Analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN58133827.152 children were recruited. 77 were assigned to PACT (London [n=26], Manchester [n=26], and Newcastle [n=25]); and 75 to treatment as usual (London [n=26], Manchester [n=26], and Newcastle [n=23]). At the 13-month endpoint, the severity of symptoms was reduced by 3.9 points (SD 4.7) on the ADOS-G algorithm in the group assigned to PACT, and 2.9 (3.9) in the group assigned to treatment as usual, representing a between-group effect size of -0.24 (95% CI -0.59 to 0.11), after adjustment for centre, sex, socioeconomic status, age, and verbal and non-verbal abilities. Treatment effect was positive for parental synchronous response to child (1.22, 0.85 to 1.59), child initiations with parent (0.41, 0.08 to 0.74), and for parent-child shared attention (0.33, -0.02 to 0.68). Effects on directly assessed language and adaptive functioning in school were small.On the basis of our findings, we cannot recommend the addition of the PACT intervention to treatment as usual for the reduction of autism symptoms; however, a clear benefit was noted for parent-child dyadic social communication.UK Medical Research Council, and UK Department for Children, Schools and Families.
| S-EPMC2890859 | biostudies-other
Project description:BackgroundIt is not known whether early intervention can improve long-term autism symptom outcomes. We aimed to follow-up the Preschool Autism Communication Trial (PACT), to investigate whether the PACT intervention had a long-term effect on autism symptoms and continued effects on parent and child social interaction.MethodsPACT was a randomised controlled trial of a parent-mediated social communication intervention for children aged 2-4 years with core autism. Follow-up ascertainment was done at three specialised clinical services centres in the UK (London, Manchester, and Newcastle) at a median of 5·75 years (IQR 5·42-5·92) from the original trial endpoint. The main blinded outcomes were the comparative severity score (CSS) from the Autism Diagnostic Observation Schedule (ADOS), the Dyadic Communication Assessment Measure (DCMA) of the proportion of child initiatiations when interacting with the parent, and an expressive-receptive language composite. All analyses followed the intention-to-treat principle. PACT is registered with the ISRCTN registry, number ISRCTN58133827.Findings121 (80%) of the 152 trial participants (59 [77%] of 77 assigned to PACT intervention vs 62 [83%] of 75 assigned to treatment as usual) were traced and consented to be assessed between July, 2013, and September, 2014. Mean age at follow-up was 10·5 years (SD 0·8). Group difference in favour of the PACT intervention based on ADOS CSS of log-odds effect size (ES) was 0·64 (95% CI 0·07 to 1·20) at treatment endpoint and ES 0·70 (95% CI -0·05 to 1·47) at follow-up, giving an overall reduction in symptom severity over the course of the whole trial and follow-up period (ES 0·55, 95% CI 0·14 to 0·91, p=0·004). Group difference in DCMA child initiations at follow-up showed a Cohen's d ES of 0·29 (95% CI -0.02 to 0.57) and was significant over the course of the study (ES 0·33, 95% CI 0·11 to 0·57, p=0·004). There were no group differences in the language composite at follow-up (ES 0·15, 95% CI -0·23 to 0·53).InterpretationThe results are the first to show long-term symptom reduction after a randomised controlled trial of early intervention in autism spectrum disorder. They support the clinical value of the PACT intervention and have implications for developmental theory.FundingMedical Research Council.
| S-EPMC5121131 | biostudies-literature
Project description:This study compared effects of two parent-mediated interventions on joint engagement outcomes as augmentations of an early intervention program for toddlers with autism spectrum disorder (ASD).Participants included 86 toddlers (range 22-36 months) with ASD and their primary caregiver. Caregiver-child dyads were randomized to receive 10 weeks of hands-on parent training in a naturalistic, developmental behavioral intervention (joint attention, symbolic play, engagement and regulation-JASPER) or a parent-only psychoeducational intervention (PEI). Dose was controlled in terms of researcher-parent contact and early intervention services received by the child.Results yielded significant effects of the JASPER intervention on the primary outcome of joint engagement. The treatment effect was large (Cohen's f² = .69) and maintained over the 6-month follow-up. JASPER effects were also found on secondary outcomes of play diversity, highest play level achieved, and generalization to the child's classroom for child-initiated joint engagement. The PEI intervention was found to be effective in reducing parenting stress associated with child characteristics. All secondary effects were generally small to moderate.These data highlight the benefit of a brief, targeted, parent-mediated intervention on child outcomes. Future studies may consider the combination of JASPER and PEI treatments for optimal parent and child outcomes. Trial registry no. NCT00999778.
| S-EPMC4755315 | biostudies-literature
Project description:Down syndrome is the most common genetic cause of intellectual disability, affecting 700-800 babies annually in the UK (Wu J, Morris J, Eur J Hum Genet 21:1016-9, 2013). Children with Down syndrome have difficulties developing language skills. These difficulties can have long-term negative consequences for all aspects of their lives including social development, education and employment opportunities, and emotional wellbeing and mental health (Irwin LG et. al 2007). These aspects all have the potential to be improved through targeted early language intervention. Parents and Children Together (PACT) is a parent-delivered early language teaching programme for typically developing pre-school children at risk of language delays. A previous project (Burgoyne K, J Child Psychol Psychiatry 59(5):545-55, 2018) showed that PACT leads to improvements in children's language and early literacy skills. Our team has worked closely with six families to adapt PACT for children with Down syndrome. The aim of the current study is to conduct a feasibility randomised controlled trial (RCT) to evaluate the feasibility of a definitive RCT and explore initial evidence of the adapted programme's potential to support children's language and literacy development. This is a two-arm feasibility randomised controlled trial in which children will be randomly allocated to either a PACT-DS group or to a waiting control group (who will receive intervention at the end of the project). We aim to recruit 28-30 children with Down syndrome (aged 3-6 years) and their parents/caregivers to take part. The PACT-DS group will be trained to deliver PACT-DS every day (20 min a day; 5 days a week) to their child over 30 weeks. We will collect data using assessments of child language and early literacy, measures of parent wellbeing, qualitative surveys and interviews, and monitoring data to explore trial feasibility (including recruitment and retention of families and adherence and acceptability of intervention) and cost and benefits. Data will be collected before intervention, immediately after the 30-week intervention programme, and 6 months after intervention ends. Clear progression criteria will be used to assess suitability for a definitive trial. This study represents initial steps in developing a definitive trial of the PACT-DS programme and will add to the limited evidence base on early language intervention for children with Down syndrome. This programme of research has the potential to make significant advancements in early language intervention research and practice for this group. The trial is registered with the ISRCTN registry: study ID ISRCTN63251282 . Registered on 14 July 2023.
| S-EPMC10702108 | biostudies-literature
Project description:ObjectivesTo compare the effects of two 9-month parent-implemented interventions within the Early Social Interaction (ESI) Project. Both individual-ESI, offered 2 or 3 times per week at home or in the community, and group-ESI, offered once per week in a clinic, taught parents how to embed strategies to support social communication throughout everyday activities.MethodsParticipants in the randomized controlled trial included 82 children diagnosed with autism spectrum disorder at 16 to 20 months. Children were matched on pretreatment nonverbal developmental level and pairs were randomly assigned to treatment condition. Child outcomes included measures of social communication, autism symptoms, adaptive behavior, and developmental level. Child outcomes are reported from baseline to the end of the 9-month interventions.ResultsChildren in individual-ESI showed differential change on a standardized examiner-administered observational measure of social communication, as they improved at a faster rate than children in group-ESI. Individual-ESI also showed differential efficacy on a parent report measure of communication, daily living, and social skills, as they showed improvement or stability, whereas group-ESI led to worsening or no significant change on these skills. Finally, individual-ESI showed differential change on examiner-administered measures of receptive language skills, as children in individual-ESI improved significantly, whereas group-ESI showed no change.ConclusionsThese findings support the efficacy of individual-ESI compared with group-ESI on child outcomes, suggesting the importance of individualized parent coaching in natural environments. The efficacy of a parent-implemented intervention using little professional time has potential for community viability, which is particularly important in light of the lack of main effects on child outcomes of most other parent-implemented interventions.
| S-EPMC4243066 | biostudies-literature
Project description:IntroductionThe PLAYshop programme is a novel, brief, theory-based, parent-focused physical literacy intervention in early childhood designed to address the major public health issue of childhood physical inactivity. The primary objective of this study is to examine the efficacy of the virtually delivered PLAYshop programme in increasing preschool-aged children's physical literacy, including fundamental movement skills and motivation and enjoyment.Methods and analysisThis study aims to recruit 130 families with preschool-aged children (3-5 years) from Alberta and British Columbia, Canada who will be randomised to an intervention or control group. The PLAYshop programme is informed by the Capability, Opportunity, Motivation, Behavior (COM-B) model and includes four intervention strategies: (1) educational training via a 60 min virtual synchronous workshop, (2) educational resources via handouts, (3) material resources via a goody bag of basic active play equipment and (4) follow-up support via access to a digital app with an online toolkit and four biweekly booster lessons (1-week, 3-week, 5-week and 7-week follow-up). To assess the primary outcome of physical literacy, five fundamental movement skills (overhand throw, underhand throw, horizontal jump, hop, one leg balance) will be measured virtually at baseline and 2-month follow-up using the Test of Gross Motor Development (TGMD) and the Movement Assessment Battery for Children-Second Edition (MABC-2) tools. Additionally, children's motivation and enjoyment will also be assessed at baseline and 2-month follow-up by: (1) parental-report using items from the Preschool Physical Literacy Assessment (PrePLAy) and (2) self-report using an adapted Five Degrees of Happiness Likert scale for children. The control group will receive the PLAYshop programme after the 2-month follow-up.Ethics and disseminationThe protocol was approved by the University of Alberta (00093764) and University of Victoria (16-444) Research Ethics Boards. Findings will be disseminated through peer-reviewed publications, conference presentations, social and traditional media and a circulated infographic.Trial registration numberNCT05255250.
| S-EPMC9772121 | biostudies-literature
Project description:Telemedicine tools have potential for increasing access to diagnostic services for children with autism spectrum disorder (ASD). Past work has utilized tele-assessment procedures in which remote psychologists observe administration of interactive screening instruments by trained, on-site providers. Although promising, this approach relies on two clinicians, limiting its efficiency and scalability. The present study examined the use, acceptability, and parents' perceptions of two caregiver-mediated tools for assessing ASD risk in toddlers, in which remote clinicians guided parents to complete interactive screening activities with their children. Most parents found tele-assessment to be comfortable, and many reported liking the parent-led nature of these tools. Parents also offered constructive feedback, which was used to modify the tele-assessment process for future study.
| S-EPMC7266386 | biostudies-literature
Project description:BackgroundPrior evidence shows that behaviours closely related to the intervention delivered for autism are amenable to change, but it is more difficult to generalise treatment effects beyond the intervention context. We test an early autism intervention designed to promote generalisation of therapy-acquired skills into home and school contexts to improve adaptive function and reduce symptoms. A detailed mechanism study will address the process of such generalisation. Objective 1 will be to test if the PACT-G intervention improves autism symptom outcome in the home and school context of the intervention as well as in the primary outcome research setting. Objective 2 will use the mechanism analysis to test for evidence of acquired skills from intervention generalizing across contexts and producing additive effects on primary outcome.Methods/designThis is a three-site, two-parallel-group, randomised controlled trial of the experimental treatment plus treatment as usual (TAU) versus TAU alone. Children aged 2-11 years (n = 244 (122 intervention/122 TAU; ~ 82/site) meeting criteria for core autism will be eligible. The experimental intervention builds on a clinic-based Pre-school Autism Communication Treatment model (PACT), delivered with the primary caregiver, combined with additional theory- and evidence-based strategies designed to enhance the generalisation of effects into naturalistic home and education contexts. The control intervention will be TAU.Primary outcomeautism symptom outcome, researcher-assessed using a standardised protocol.Secondary outcomesautism symptoms, child interaction with parent or teacher, language and reported functional outcomes in home and school settings. Outcomes measured at baseline and 12-month endpoint in all settings with interim interaction measurements (7 months) to test treatment effect mechanisms. Primary analysis will estimate between-group difference in primary outcome using analysis of covariance with test of homogeneity of effect across age group. Mechanism analysis will use regression models to test for mediation on primary outcome by parent-child and teaching staff-child social interaction.DiscussionThis is an efficacy and mechanism trial of generalising evidence-based autism treatment into home and school settings. It will provide data on whether extending treatment across naturalistic contexts enhances overall effect and data on the mechanism in autism development of the generalisation of acquired developmental skills across contexts.Trial registrationISRCTN, ID: 25378536 . Prospectively registered on 9 March 2016.
| S-EPMC6150959 | biostudies-literature
Project description:Purpose Despite advances in cochlear implant and hearing aid technology, many children with hearing loss continue to exhibit poorer language skills than their hearing peers. This randomized pilot trial tested the effects of a parent-implemented communication treatment targeting prelinguistic communication skills in infants and toddlers with hearing loss. Method Participants included 19 children between 6 and 24 months of age with moderate to profound, bilateral hearing loss. Children were randomly assigned to the parent-implemented communication treatment group or a "usual care" control group. Parents and children participated in 26, hour-long home sessions in which parents were taught to use communication support strategies. The primary outcome measures were the Communication and Symbolic Behavior Scales (Wetherby & Prizant, 2003), a measure of child prelinguistic skills, and parental use of communication support strategies during a naturalistic play session. Results Parents in the treatment group increased their use of communication support strategies by 17%. Children in the treatment group made statistically significant more gains in speech prelinguistic skills ( d = 1.09, p = .03) as compared with the control group. There were no statistically significant differences in social and symbolic prelinguistic skills; however, the effect sizes were large ( d = 0.78, p = .08; d = 0.91, p = .10). Conclusions This study provides modest preliminary support for the short-term effects of a parent-implemented communication treatment for children with hearing loss. Parents learned communication support strategies that subsequently impacted child prelinguistic skills. Although these results appear promising, the sample size is very small. Future research should include a larger clinical trial and child-level predictors of response to treatment.
| S-EPMC6437700 | biostudies-literature
Project description:Background:Children born preterm are at increased risk of autism spectrum disorder (ASD). n-3 (?-3) Combined with n-6 (?-6) fatty acids including ?-linolenic acid (GLA) may benefit children born preterm showing early signs of ASD. Previous trials have reported that docosahexaenoic acid (DHA) promotes cognitive development in preterm neonates and n-3 fatty acids combined with GLA improve attention-deficit-hyperactivity disorder. Objectives:The objectives of the pilot Preemie Tots Trial were 1) to confirm the feasibility of a full-scale trial in toddlers born very preterm and exhibiting ASD symptoms and 2) to explore the effects of supplementation on parent-reported ASD symptoms and related behaviors. Methods:This was a 90-d randomized, fully blinded, placebo-controlled trial in 31 children 18-38 mo of age who were born at ?29 wk of gestation. One group was assigned to daily Omega-3-6-9 Junior (Nordic Naturals, Inc.) treatment (including 338 mg eicosapentaenoic acid, 225 mg DHA, and 83 mg GLA), and the other group received canola oil (124 mg palmitic acid, 39 mg stearic acid, 513 mg linoleic acid, 225 mg ?-linolenic acid, and 1346 mg oleic acid). Mixed-effects regression analyses followed intent-to-treat analysis and explored effects on parent-reported ASD symptoms and related behaviors. Results:Of 31 children randomly assigned, 28 had complete outcome data. After accounting for baseline scores, those assigned to treatment exhibited a greater reduction in ASD symptoms per the Brief Infant Toddler Social Emotional Assessment ASD scale than did those assigned to placebo (difference in change = - 2.1 points; 95% CI: - 4.1, - 0.2 points; standardized effect size = - 0.71). No other outcome measure reflected a similar magnitude or a significant effect. Conclusions:This pilot trial confirmed adequate numbers of children enrolled and participated fully in the trial. No safety concerns were noted. It also found clinically-significant improvements in ASD symptoms for children randomly assigned to receive Omega-3-6-9 Junior, but effects were confined to one subscale. A future full-scale trial is warranted given the lack of effective treatments for this population. This trial was registered at www.clinicaltrials.gov as NCT01683565.
| S-EPMC6251698 | biostudies-literature