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Parent-mediated communication-focused treatment in children with autism (PACT): a randomised controlled trial.

ABSTRACT: 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), 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.

SUBMITTER: Green J

PROVIDER: S-EPMC2890859 | biostudies-other | 2010 Jun

REPOSITORIES: biostudies-other

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Parent-mediated communication-focused treatment in children with autism (PACT): a randomised controlled trial.

Green Jonathan J Charman Tony T McConachie Helen H Aldred Catherine C Slonims Vicky V Howlin Pat P Le Couteur Ann A Leadbitter Kathy K Hudry Kristelle K Byford Sarah S Barrett Barbara B Temple Kathryn K Macdonald Wendy W Pickles Andrew A

Lancet (London, England) 20100520 9732

<h4>Background</h4>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.<h4>Methods</h4>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 spe ...[more]

PMID: 20494434

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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.

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.

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.

Project description:BackgroundThere are very few mechanistic studies of the long-term impact of psychosocial interventions in childhood. The parent-mediated Paediatric Autism Communication Therapy (PACT) RCT showed sustained effects on autistic child outcomes from pre-school to mid-childhood. We investigated the mechanism by which the PACT intervention achieved these effects.MethodsOf 152 children randomised to receive PACT or treatment as usual between 2 and 5 years of age, 121 (79.6%) were followed 5-6 years after the endpoint at a mean age of 10.5 years. Assessors, blind to the intervention group, measured Autism Diagnostic Observation Scale Calibrated Severity Score (ADOS CSS) for child autistic behaviours and Teacher Vineland (TVABS) for adaptive behaviour in school. Hypothesised mediators were child communication initiations with caregivers in a standard play observation (Dyadic Communication Measure for Autism, DCMA). Hypothesised moderators of mediation were baseline child non-verbal age equivalent scores (AE), communication and symbolic development (CSBS) and 'insistence on sameness' (IS). Structural equation modelling was used in a repeated measures mediation design.ResultsGood model fits were obtained. The treatment effect on child dyadic initiation with the caregiver was sustained through the follow-up period. Increased child initiation at treatment midpoint mediated the majority (73%) of the treatment effect on follow-up ADOS CSS. A combination of partial mediation from midpoint child initiations and the direct effect of treatment also contributed to a near-significant total effect on follow-up TVABS. No moderation of this mediation was found for AE, CSBS or IS.ConclusionsEarly sustained increase in an autistic child's communication initiation with their caregiver is largely responsible for the long-term effects from PACT therapy on autistic and adaptive behaviour outcomes. This supports the theoretical logic model of PACT therapy but also illuminates fundamental causal processes of social and adaptive development in autism over time: early social engagement in autism can be improved and this can have long-term generalised outcome effects.

Project description:BackgroundEarly parent-implemented intervention enhances parent-child interaction and improves language skills in children with autism spectrum disorders (ASD). Parent coaching is often delivered as standard care for children with ASD, where parents are taught to apply strategies in their child's play activities and daily routines to achieve the prior stated goals. However, the ability to conduct parent coaching in physical in-clinic sessions is limited by resource constraints such as clinic space and therapist manpower. Furthermore, parents may experience difficulties with the generalisation of intervention strategies taught in the clinic to their natural home environments. In this study, telerehabilitation is evaluated as an alternative platform to deliver parent coaching for parent-implemented interventions to children with ASD in their homes.MethodsThis parallel-group, randomised, controlled, non-inferiority trial aims to evaluate the effectiveness of parent coaching delivered through video conferencing (telerehabilitation) versus in-clinic (standard care) delivery. Children aged 15 to 48 months (n = 200) who meet the cut-off score for ASD on the Autism Diagnostic Observation Schedule-2 are eligible. Parent-child dyads are randomly assigned to receive parent coaching either through weekly telerehabilitation or standard care. The primary outcome is the child's development as measured by the subscale and composite scores of a standardised developmental assessment. Primary analysis will determine if the lower boundary of the 95% confidence interval for the mean difference in pre-post change between groups exceeds -5 (the non-inferiority margin). Secondary outcomes are the child's adaptive behaviour, parent-child interaction, parental stress, and family quality of life. Outcomes will be measured pre-intervention, midterm, and post-intervention. Secondary analysis will determine if there is any between-group difference for the pre-post change in scores at the 5% significance level using two-sample t-test or Mann-Whitney U test.DiscussionAs a randomised controlled trial of a moderately large scale, this study will contribute to the limited existing literature on the effectiveness of parent coaching via telerehabilitation for early parent-implemented intervention for children with ASD. The results of this study will provide insights on whether telerehabilitation is comparable to conventional in-clinic parent coaching in enhancing parent-child interaction and improving language skills.Trial registrationClinicalTrials.gov NCT05792449. Registered (retrospectively) on 31 March 2023.

Project description:Previous research has suggested that music therapy may facilitate skills in areas typically affected by autism spectrum disorders such as social interaction and communication. However, generalisability of previous findings has been restricted, as studies were limited in either methodological accuracy or the clinical relevance of their approach. The aim of this study is to determine effects of improvisational music therapy on social communication skills of children with autism spectrum disorders. An additional aim of the study is to examine if variation in dose of treatment (i.e., number of music therapy sessions per week) affects outcome of therapy, and to determine cost-effectiveness.Children aged between 4;0 and 6;11 years who are diagnosed with autism spectrum disorder will be randomly assigned to one of three conditions. Parents of all participants will receive three sessions of parent counselling (at 0, 2, and 5 months). In addition, children randomised to the two intervention groups will be offered individual, improvisational music therapy over a period of five months, either one session (low-intensity) or three sessions (high-intensity) per week. Generalised effects of music therapy will be measured using standardised scales completed by blinded assessors (Autism Diagnostic Observation Schedule, ADOS) and parents (Social Responsiveness Scale, SRS) before and 2, 5, and 12 months after randomisation. Cost effectiveness will be calculated as man years. A group sequential design with first interim look at N = 235 will ensure both power and efficiency.Responding to the need for more rigorously designed trials examining the effectiveness of music therapy in autism spectrum disorders, this pragmatic trial sets out to generate findings that will be well generalisable to clinical practice. Addressing the issue of dose variation, this study's results will also provide information on the relevance of session frequency for therapy outcome.Current Controlled Trials ISRCTN78923965.

Project description:INTRODUCTION:Incidence of autistic traits, mental health problems, stress and poor coping is high among family members of children with autism. These problems are coupled with challenging behaviour among children with autism. Current treatment for these families is disjointed and costly. The need for whole family support is supported by the National Institute for Health and Care Excellence recommendations, developments regarding children's service provision, research and requests by families of children with autism. Despite evidence that family therapies can provide benefits to these families, efficacy has not been subject to a randomised controlled trial. Systemic Autism-related Family Enabling (SAFE) is a new family therapy intervention designed specifically for families of children with autism. We aim to establish the feasibility of running a fully powered randomised controlled trial to evaluate SAFE. METHODS AND ANALYSIS:Families of children with autism aged 3-16 years will be invited to participate. Consenting participants will be randomised 2:1 to either SAFE+support as usual or support as usual alone. The proposed primary outcome measure for the main trial will be the Systemic CORE 15. Participants will also complete proposed secondary outcome measures, indexing changes in child behaviour, child-parent attachment, anxiety and depression. Generic health economic outcome measures (EuroQol 5 dimensions and Child Health Utility 9 Dimensions) will also provide data on the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline and 32 weeks post-allocation. Data on ability to identify, recruit, randomise, retain and collect data from families, acceptability of outcome measures, adherence of therapists and families to the intervention, appropriateness of resource use questionnaires and effectiveness of training will be collected for feasibility analysis. Qualitative data will also explore acceptability of SAFE and reasons for declining and withdrawing from the study. ETHICS AND DISSEMINATION:The current trial protocol received ethical approval from the South West-Exeter Research Ethics Committee (Ref: 17/SW/0192). The findings of the trial will be disseminated in collaboration with our Family Consultation Group and other partners. Findings will be shared locally, nationally and internationally through events, conferences and published papers. TRIAL REGISTRATION NUMBER:ISCTRN83964946 (Pre-results) IRAS 213527.

Dataset Information

Parent-mediated communication-focused treatment in children with autism (PACT): a randomised controlled trial.

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Parent-mediated communication-focused treatment in children with autism (PACT): a randomised controlled trial.

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