TY - JOUR
T1 - Combined social communication therapy at home and in education for young autistic children in England (PACT-G)
T2 - a parallel, single-blind, randomised controlled trial
AU - Green, Jonathan
AU - Leadbitter, Kathy
AU - Ellis, Ceri
AU - Taylor, Lauren
AU - Moore, Heather L
AU - Carruthers, Sophie
AU - James, Kirsty
AU - Taylor, Carol
AU - Balabanovska, Matea
AU - Langhorne, Sophie
AU - Aldred, Catherine
AU - Slonims, Vicky
AU - Grahame, Victoria
AU - Parr, Jeremy
AU - Humphrey, Neil
AU - Howlin, Patricia
AU - McConachie, Helen
AU - Couteur, Ann Le
AU - Charman, Tony
AU - Emsley, Richard
AU - Pickles, Andrew
N1 - Funding Information:
JG and AP are National Institute for Health Research (NIHR) senior investigators (NIHR NF-SI-0617-10168 for JG and NF-SI-0617-10120 for AP). RE is supported by an NIHR Research Professorship (NIHR300051) and is a member of NIHR Clinical Trials Unit Standing Advisory Committee and Health Technology Assessment Clinical Evaluation and Trials Committee. JG and CA receive director's fees from a not-for-profit PACT training company IMPACT (CiC 10902031). SC is funded by the UK Medical Research Council (MRC). TC has served as a paid consultant to F Hoffmann-La Roche and Servier, and has received royalties from Sage Publications and Guilford Publications. AP receives book and questionnaire royalties from Western Psychological Services, Oxford University Press, and Imperial College Press. All other authors declare no competing interests.
Funding Information:
This study was funded by the NIHR and MRC Efficacy and Mechanism Evaluation Award 1/2/2016?31/12/2019. This Article presents independent research part funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London. The views expressed in this Article are those of the authors and not necessarily those of the UK National Health Service (NHS), the NIHR, or the Department of Health and Social Care. We gratefully acknowledge the invaluable contribution of all the participating families in the study, participating nurseries and schools, and referring clinicians. We gratefully acknowledge invaluable training and outstanding collaboration from Catherine Lord, Alison Holbrook, Sue Fletcher-Watson, Sheri Stegall. We thank the members of the PACT-G trial group: Hilary Beach, Imogen Crook, Hannah Danvers, Kate Dartnall, Hannah Foote, Jessica Graham, Sarah Jamieson, Anna Kappa, Ruth Madeley, Deborah Maskell, Olivia Mitchell, Francisca Monteiro, Cat Papastavrou Brooks, Amelia Pearson, Leanne Rogan, Lisa Slater, Susanna Vosper, and Helen Wilson. We sincerely thank the members of the Trial Steering Committee: Stuart Logan (chair), Anne O'Hare (deceased), Emily Jones, and Louisa Harrison and the Data Monitoring and Ethics Committee, Paul Ramchandani (chair), and Jacqueline Barnes, for their valuable guidance and support during the work. We gratefully acknowledge the contributions of Alana Barnett, Lydia Johnson-Ferguson, Rachel Lisle, and Hafiza Sadiq; DCMA coders Lucy Dempster and Laura Kidd; UK BOSCC coders Young Ah Kim, Nicole El Hawi, Chloe Hayes, Leonie Luk, Laurie Preston, Rachel Randle, and Owen Waddington; and US BOSCC coders Katherine Byrne, Gabrielle Gunin, Alison Holbrook, Alapika Jatkar, Kassandra Martinez, Allison Megale, Nicole Rosen, Maira Tafolla, Sofia Ahmed, Rebekah Howell, and Caitlin Goldie.
Funding Information:
This study was funded by the NIHR and MRC Efficacy and Mechanism Evaluation Award 1/2/2016–31/12/2019. This Article presents independent research part funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London. The views expressed in this Article are those of the authors and not necessarily those of the UK National Health Service (NHS), the NIHR, or the Department of Health and Social Care. We gratefully acknowledge the invaluable contribution of all the participating families in the study, participating nurseries and schools, and referring clinicians. We gratefully acknowledge invaluable training and outstanding collaboration from Catherine Lord, Alison Holbrook, Sue Fletcher-Watson, Sheri Stegall. We thank the members of the PACT-G trial group: Hilary Beach, Imogen Crook, Hannah Danvers, Kate Dartnall, Hannah Foote, Jessica Graham, Sarah Jamieson, Anna Kappa, Ruth Madeley, Deborah Maskell, Olivia Mitchell, Francisca Monteiro, Cat Papastavrou Brooks, Amelia Pearson, Leanne Rogan, Lisa Slater, Susanna Vosper, and Helen Wilson. We sincerely thank the members of the Trial Steering Committee: Stuart Logan (chair), Anne O’Hare (deceased), Emily Jones, and Louisa Harrison and the Data Monitoring and Ethics Committee, Paul Ramchandani (chair), and Jacqueline Barnes, for their valuable guidance and support during the work. We gratefully acknowledge the contributions of Alana Barnett, Lydia Johnson-Ferguson, Rachel Lisle, and Hafiza Sadiq; DCMA coders Lucy Dempster and Laura Kidd; UK BOSCC coders Young Ah Kim, Nicole El Hawi, Chloe Hayes, Leonie Luk, Laurie Preston, Rachel Randle, and Owen Waddington; and US BOSCC coders Katherine Byrne, Gabrielle Gunin, Alison Holbrook, Alapika Jatkar, Kassandra Martinez, Allison Megale, Nicole Rosen, Maira Tafolla, Sofia Ahmed, Rebekah Howell, and Caitlin Goldie.
Publisher Copyright:
© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
PY - 2022/4
Y1 - 2022/4
N2 - BACKGROUND: Autistic children can have difficulty generalising treatment effects beyond the immediate treatment context. Paediatric Autism Communication Therapy (PACT) has been successful when delivered in the clinic. Here we tested the Paediatric Autism Communication Therapy-Generalised (PACT-G) intervention combined between home and education settings for its overall effect and mechanistic transmission of effect across contexts.METHODS: In this parallel, single-blind, randomised, controlled trial, we recruited autistic children aged 2-11 years in urban or semi-urban areas in Manchester, Newcastle, and London, England. Children needed to meet core autism criteria on Autism Diagnostic Observation Schedule-second edition (ADOS-2) and parent-rated Social Communication Questionnaire (SCQ-lifetime), and children older than 5 years were included if they had intentional communication but expressive language equivalent of age 4 years or younger. Eligible children were randomly assigned (1:1), using block randomisation (random block sizes of 2 and 4) and stratified for site, age (2-4 years vs 5-11 years), and gender, to either PACT-G plus treatment as usual or treatment as usual alone. Research assessors were masked to treatment allocation. The PACT-G intervention was delivered by a therapist in parallel to the child's parents at home and to learning-support assistants (LSA) at their place of education, using both in-person and remote sessions over a 6 month period, to optimise adult-child social interaction. Treatment as usual included any health support or intervention from education or local community services. The primary outcome was autism symptom severity using the ADOS-2, as measured by researchers, at 12 months versus baseline. Secondary outcomes were Brief Observation of Social Communication Change (BOSCC) and dyadic social interaction between child and adult across contexts, both at 12 months. Other secondary outcome measures were assessed using the following composites: language, anxiety, repetitive behaviour, adaptive behaviour, parental wellbeing, child health-related quality of life, and disruptive behaviour. Assessments were done at baseline, 7 months, and 12 months. We used an intention-to-treat (ITT) analysis of covariance for the efficacy outcome measures. Adverse events were assessed by researchers for all trial families at each contact and by therapists in the PACT-G group at each visit. This study is registered with the ISRCTN Registry, ISRCTN 25378536.FINDINGS: Between Jan 18, 2017, and April 19, 2018, 555 children were referred and 249 were eligible, agreed to participate, and were randomly assigned to either PACT-G (n=122) or treatment as usual (n=127). One child in the PACT-G group withdrew and requested their data be removed from the study, giving an ITT population of 248 children. 51 (21%) of 248 children were female, 197 (79%) were male, 149 (60%) were White, and the mean age was 4·0 years (SD 0·6). The groups were well balanced for demographic and clinical characteristics. In the PACT-G group, parents of children received a median of 10 (IQR 8-12) home sessions and LSAs received a median of 8 (IQR 5-10) education sessions over 6 months. We found no treatment effect on the ADOS-2 primary outcome compared with treatment as usual (effect size 0·04 [95% CI -0·19 to 0·26]; p=0·74), or researcher-assessed BOSCC (0·03 [-0·25 to 0·31]), language composite (-0·03 [-0·15 to 0·10]), repetitive behaviour composite (0·00 [-0·35 to 0·35]), adaptive behaviour composite (0·01 [-0·15 to 0·18]), or child wellbeing (0·09 [-0·15 to 0·34]). PACT-G treatment improved synchronous response in both parent (0·50 [0·36 to 0·65]) and LSA (0·33 [0·16 to 0·50]), mediating increased child communication with parent (0·26 [0·12 to 0·40]) and LSA (0·20 [0·06 to 0·34]). Child dyadic communication change mediated outcome symptom alteration on BOSCC at home (indirect effect -0·78 [SE 0·34; 95% CI -1·44 to -0·11]; p=0·022) although not in education (indirect effect -0·67 [SE 0·37; 95% CI -1·40 to 0·06]; p=0·073); such an effect was not seen on ADOS-2. Treatment with PACT-G also improved the parental wellbeing composite (0·44 [0·08 to 0·79]) and the child disruptive behaviour composite in home and education (0·29 [0·01 to 0·57]). Adverse events on child behaviour and wellbeing were recorded in 13 (10%) of 127 children in the treatment as usual group (of whom four [31%] were girls) and 11 (9%) of 122 in the PACT-G group (of whom three [33%] were girls). One serious adverse event on parental mental health was recorded in the PACT-G group and was possibly study related.INTERPRETATION: Although we found no effect on the primary outcome compared with treatment as usual, adaptation of the 12-month PACT intervention into briefer multicomponent delivery across home and education preserved the positive proximal outcomes, although smaller in effect size, and the original pattern of treatment mediation seen in clinic-delivered therapy, as well as improving parental wellbeing and child disruptive behaviours across home and school. Reasons for this reduced efficacy might be the reduced dose of each component, the effect of remote delivery, and the challenges of the delivery contexts. Caution is needed in assuming that changing delivery methods and context will preserve an original intervention efficacy for autistic children.FUNDING: National Institute for Health Research and Medical Research Council Efficacy and Mechanism Evaluation Award.
AB - BACKGROUND: Autistic children can have difficulty generalising treatment effects beyond the immediate treatment context. Paediatric Autism Communication Therapy (PACT) has been successful when delivered in the clinic. Here we tested the Paediatric Autism Communication Therapy-Generalised (PACT-G) intervention combined between home and education settings for its overall effect and mechanistic transmission of effect across contexts.METHODS: In this parallel, single-blind, randomised, controlled trial, we recruited autistic children aged 2-11 years in urban or semi-urban areas in Manchester, Newcastle, and London, England. Children needed to meet core autism criteria on Autism Diagnostic Observation Schedule-second edition (ADOS-2) and parent-rated Social Communication Questionnaire (SCQ-lifetime), and children older than 5 years were included if they had intentional communication but expressive language equivalent of age 4 years or younger. Eligible children were randomly assigned (1:1), using block randomisation (random block sizes of 2 and 4) and stratified for site, age (2-4 years vs 5-11 years), and gender, to either PACT-G plus treatment as usual or treatment as usual alone. Research assessors were masked to treatment allocation. The PACT-G intervention was delivered by a therapist in parallel to the child's parents at home and to learning-support assistants (LSA) at their place of education, using both in-person and remote sessions over a 6 month period, to optimise adult-child social interaction. Treatment as usual included any health support or intervention from education or local community services. The primary outcome was autism symptom severity using the ADOS-2, as measured by researchers, at 12 months versus baseline. Secondary outcomes were Brief Observation of Social Communication Change (BOSCC) and dyadic social interaction between child and adult across contexts, both at 12 months. Other secondary outcome measures were assessed using the following composites: language, anxiety, repetitive behaviour, adaptive behaviour, parental wellbeing, child health-related quality of life, and disruptive behaviour. Assessments were done at baseline, 7 months, and 12 months. We used an intention-to-treat (ITT) analysis of covariance for the efficacy outcome measures. Adverse events were assessed by researchers for all trial families at each contact and by therapists in the PACT-G group at each visit. This study is registered with the ISRCTN Registry, ISRCTN 25378536.FINDINGS: Between Jan 18, 2017, and April 19, 2018, 555 children were referred and 249 were eligible, agreed to participate, and were randomly assigned to either PACT-G (n=122) or treatment as usual (n=127). One child in the PACT-G group withdrew and requested their data be removed from the study, giving an ITT population of 248 children. 51 (21%) of 248 children were female, 197 (79%) were male, 149 (60%) were White, and the mean age was 4·0 years (SD 0·6). The groups were well balanced for demographic and clinical characteristics. In the PACT-G group, parents of children received a median of 10 (IQR 8-12) home sessions and LSAs received a median of 8 (IQR 5-10) education sessions over 6 months. We found no treatment effect on the ADOS-2 primary outcome compared with treatment as usual (effect size 0·04 [95% CI -0·19 to 0·26]; p=0·74), or researcher-assessed BOSCC (0·03 [-0·25 to 0·31]), language composite (-0·03 [-0·15 to 0·10]), repetitive behaviour composite (0·00 [-0·35 to 0·35]), adaptive behaviour composite (0·01 [-0·15 to 0·18]), or child wellbeing (0·09 [-0·15 to 0·34]). PACT-G treatment improved synchronous response in both parent (0·50 [0·36 to 0·65]) and LSA (0·33 [0·16 to 0·50]), mediating increased child communication with parent (0·26 [0·12 to 0·40]) and LSA (0·20 [0·06 to 0·34]). Child dyadic communication change mediated outcome symptom alteration on BOSCC at home (indirect effect -0·78 [SE 0·34; 95% CI -1·44 to -0·11]; p=0·022) although not in education (indirect effect -0·67 [SE 0·37; 95% CI -1·40 to 0·06]; p=0·073); such an effect was not seen on ADOS-2. Treatment with PACT-G also improved the parental wellbeing composite (0·44 [0·08 to 0·79]) and the child disruptive behaviour composite in home and education (0·29 [0·01 to 0·57]). Adverse events on child behaviour and wellbeing were recorded in 13 (10%) of 127 children in the treatment as usual group (of whom four [31%] were girls) and 11 (9%) of 122 in the PACT-G group (of whom three [33%] were girls). One serious adverse event on parental mental health was recorded in the PACT-G group and was possibly study related.INTERPRETATION: Although we found no effect on the primary outcome compared with treatment as usual, adaptation of the 12-month PACT intervention into briefer multicomponent delivery across home and education preserved the positive proximal outcomes, although smaller in effect size, and the original pattern of treatment mediation seen in clinic-delivered therapy, as well as improving parental wellbeing and child disruptive behaviours across home and school. Reasons for this reduced efficacy might be the reduced dose of each component, the effect of remote delivery, and the challenges of the delivery contexts. Caution is needed in assuming that changing delivery methods and context will preserve an original intervention efficacy for autistic children.FUNDING: National Institute for Health Research and Medical Research Council Efficacy and Mechanism Evaluation Award.
KW - Adult
KW - Autistic Disorder/psychology
KW - Child
KW - Child, Preschool
KW - Communication
KW - England
KW - Female
KW - Humans
KW - Male
KW - Quality of Life
KW - Single-Blind Method
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85126604867&partnerID=8YFLogxK
U2 - 10.1016/S2215-0366(22)00029-3
DO - 10.1016/S2215-0366(22)00029-3
M3 - Article
C2 - 35305746
SN - 2215-0366
VL - 9
SP - 307
EP - 320
JO - The lancet. Psychiatry
JF - The lancet. Psychiatry
IS - 4
ER -