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

May combine two claims. The quote only partly states this claim.

At the 13-month endpoint, the adjusted between-group difference in ADOS-G social communication algorithm score was -1.00 (95% CI -2.45 to 0.46), corresponding to an effect size of -0.24 (95% CI -0.59 to 0.11), which was not statistically significant.

“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.”

• Also stated in: § Results · plain

  “This last adjusted estimate corresponded to an effect size of −0·24 (−0·59 to 0·11).”

• Also stated in: § Discussion · plain

  “The endpoint scores for symptoms of autism improved in both groups, with only a small estimated group difference in favour of the PACT intervention.”

May combine two claims.

Teacher-rated adaptive functioning in school showed no significant treatment effect, with differences of -3.52 (95% CI -7.55 to 0.52) for Vineland Communication and -2.76 (95% CI -6.65 to 1.14) for Adaptive Behavior Composite standard scores.

“No differences were noted with the teacher Vineland Communication and Adaptive Behavior Composite standard scores, with differences of −3·52 (−7·55 to 0·52) and −2·76 (−6·65 to 1·14), respectively.”

May combine two claims.

Directly assessed child language showed no significant treatment effect, with small estimates for Preschool Language Scales receptive (0.07, 95% CI -1.95 to 2.08) and expressive (-0.35, 95% CI -1.85 to 1.16) raw scores.

“Effects on directly assessed language and adaptive functioning in school were small.”

• Also stated in: § Results · plain

  “were small: 0·07 (95% CI −1·95 to 2·08) for receptive scores and −0·35 (−1·85 to 1·16) for expressive scores.”

• Also stated in: § Discussion · plain

  “There was no group difference in standardised assessor-rated measures of child language.”

The quote only partly states this claim.

Parent-rated MCDI expressive scores did not show a significant treatment effect (21.37, 95% CI -6.42 to 49.16).

“21·37 (−6·42 to 49·16) for the MCDI expressive scores”

May combine two claims.

Pre-planned tests found no significant interaction between treatment and centre, non-verbal ability, language level, baseline autism severity, age group, or socioeconomic status.

“The pre-planned tests of interactions with treatment were not significant for centre (p=0·52), non-verbal ability of more than 24 months (p=0·47), language level (Preschool Language Scale expressive raw score >12; p=0·51), severity of baseline symptoms of autism (ADOS-G algorithm >17; p=0·85); age group (>42 months; p=0·46), and socioeconomic status (p=0·10).”

• Also stated in: § Discussion · plain

  “There was no effect of child age, baseline autism severity, non-verbal ability, or socioeconomic status on intervention effect.”

May combine two claims.

The intervention significantly alters parent-child dyadic social communication, and these changes are associated with subsequent positive child outcomes in longitudinal studies.

“The intervention does however significantly alter parent-child dyadic social communication in ways that are associated with subsequent positive child outcomes in longitudinal studies of autism,29,30 and are likely to be also positive for parents themselves.”

• cites [29] Siller, 2002, The behaviors of parents of children with autism predict the subsequent development of their children's communication, J Autism Dev Disord sourceNot checked yet

  Not checked in the free run.

• cites [30] Siller, 2008, Modeling longitudinal change in the language abilities of children with autism: parent behaviors and child characteristics as predictors of change, Dev Psychol sourceNot checked yet

  Not checked in the free run.

May combine two claims.

Training parents of young children with autism improved child communication and parent-child interaction, but most studies had inadequate research design.

“Provision of training to parents of young children with autism spectrum disorder led to improved child communication and parent-child interaction, but the research design was inadequate in most studies.9,10”

• cites [9] Diggle, 2003Not checked yet

  Not checked in the free run.

• cites [10] McConachie, 2007, Parent implemented early intervention for young children with autism spectrum disorder: a systematic review, J Eval Clin Pract sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

Multiple imputation with iterative chained equations was used to complete missing data.

“Multiple imputation, with the iterative-chained-equation method (ice procedure25), was used to complete the small amount of missing data.”

May combine two claims.

In a trial of a moderately intensive therapist-delivered social communication intervention including parent training, benefits were reported particularly in language but not in ADOS-G severity score.

“In a trial of a moderately intensive (16 h per week for 2 years) therapist delivered social communication intervention that included parent-training, benefits were reported, particularly in language, but not changes to ADOS-G severity score.16”

• cites [16] Dawson, 2010, Randomized, controlled trial of an intervention for toddlers with autism: the Early Start Denver Model, Pediatrics sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Treatment as usual was balanced across the groups.

“Treatment as usual was balanced across the groups.”

May combine two claims.

Inter-rater reliability for ADOS-G was 0.79 for the standard social-communication algorithm and 0.83 with the described scoring modifications.

“Inter-rater reliability was estimated from 66 ratings made from 15 randomly sampled tapes during the trial; intraclass correlation among researchers was 0·79 for the standard social-communication algorithm score, and 0·83 with the described scoring modifications.”

Classified as probably not a substantial claim. May combine two claims.

Assessors and supervising research staff were unaware of treatment allocation, but families and therapists could not be masked.

“Assessors and supervising research staff were unaware of the treatment allocation; however, treatment allocation could not be masked from families and therapists.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Large trial sizes generally produce small effects.

“Large trial sizes generally produce small effects,31”

• cites [31] McMahon, 2008, Do larger studies find smaller effects? The example of studies for the prevention of conduct disorder, Eur Child Adolesc Psychiatry sourceNot checked yet

  Not checked in the free run.

May combine two claims.

The trial was rigorously done with particular attention to masking assessment, especially for the primary outcome.

“our trial was rigorously done with particular attention to methods of masking assessment, especially for our primary outcome.”

May combine two claims.

The trial was powered to detect effect sizes of 0.8, 0.6, 0.5, and 0.4 SD with greater than 99%, 98%, 90%, and 75% power, respectively, allowing for 10% attrition.

“Target recruitment was 144 families, and was powered on the basis of the pilot study effect size for ADOS-G of 0·9212 and allowing for 10% attrition, to provide greater than 99%, 98%, 90%, and 75% power for effect sizes of 0·8 SD (reduction of about 4·0 points), 0·6 SD (reduction of about 3·0 points), 0·5 SD (reduction of about 2·5 points), and 0·4 SD (reduction of about 2·0 points), respectively,”

May combine two claims.

Inter-rater reliability for parent-child interaction measures was 0.80 for parental synchrony, 0.59 for child initiations, and 0.58 for shared attention.

“Inter-rater reliability between assessors (66 independent ratings made from 22 tapes throughout the study) showed intraclass correlations of 0·80 (parental synchrony), 0·59 (child initiations), and 0·58 (shared attention).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Randomisation used minimisation on treatment centre, age, and autism severity.

“This statistician ran an allocation schedule that was computer-generated by use of probabilistic minimisation of imbalance in the marginal distribution of treatment centre, age (≤42 months or >42 months), and autism severity (ADOS-G algorithm score 12–17 or 18–24).”

Classified as probably not a substantial claim.

Endpoint ADOS-G ratings were made from anonymised videotapes by an assessor from a different trial site, unaware of case details and treatment status.

“Endpoint ADOS-G ratings were made from anonymised videotapes by an assessor from a different trial site to the ADOS-G administrator, unaware of the case details and treatment status.”

May combine two claims.

The two treatment groups were well matched for demographic variables except that socioeconomic status and parental qualifications were higher in the PACT group.

“Table 1 shows that the two treatment groups were well matched for demographic variables except that socioeconomic status and proportion of parents with qualifications gained after age 16 years were higher in the group given PACT than in the group given treatment as usual, particularly in London (Cohen's d index effect size28 for difference between groups was 0·48 for education qualifications and 0”

Classified as probably not a substantial claim.

Analysis was by intention to treat.

“Analysis was by intention to treat.”

• Also stated in: § Statistical analysis · plain

  “Primary analysis was by intention to treat and regression ANCOVA”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

The intervention is likely to be positive for parents themselves.

“and are likely to be also positive for parents themselves.”

Classified as probably not a substantial claim.

Video ratings for parent-child interaction were masked to group status, assessment point, and prior hypothesis.

“Video ratings, masked to group status, assessment point, and prior hypothesis, were based on three prespecified variables: proportion of parental communications with the child that were synchronous; proportion of child communications with the parent that were initiations; and proportion of time spent in mutual shared attention.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Execution of the study was overseen by an independent trial steering committee that approved the trial analysis and its interpretation.

“Execution of the study was overseen by an independent trial steering committee that approved the trial analysis and its interpretation.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Neither funder nor sponsor had any involvement with data collection, analysis, write up, or interpretation of the study.

“Neither funder nor sponsor (University of Manchester) had any involvement with data collection, analysis, write up, or interpretation of the study.”

May combine two claims.

The ADOS-G scoring procedure was modified to improve sensitivity to change, including adjusting scores for children with no spoken words at baseline, using the same module at both assessment points, and retaining the full range of item codes without recoding 3 to 2.

“After pretrial consultation with the scale developer (Lord C, University of Michigan, Ann Arbor, MI, USA, personal communication), the scoring procedure was modified to improve sensitivity to change: scores for children with no spoken words at baseline were adjusted to avoid a systematic rating bias, since children developing words during treatment become liable to increased scores for deviant”