CRITICALLY APPRAISED PAPER (CAP) Kasari, C., Lawton, K., Shih, W., Barker, T. V., Landa, R., Lord, C.,... Senturk, D. (2014). Caregiver-mediated intervention for low-resourced preschoolers with autism: An RCT. Pediatrics, 134(1), e72 e79. http://dx.doi.org/10.1542/peds.2013-3229 CLINICAL BOTTOM LINE: Parent-Mediated Interventions Autism spectrum disorder (ASD) is a growing diagnosis in the United States, with many individuals receiving early intervention services, including occupational therapy, to address related developmental challenges. Parent-mediated interventions have emerged as a tool to support parents and children to address the child s developmental challenges in their home, a natural setting. This study implemented a parent-mediated intervention with 112 low-resourced families (mother with a high school diploma or lower, unemployed primary caregiver, or family receiving government assistance, e.g., Medicaid) to address joint attention, which is an essential element of social communication and a core deficit among children with ASD. The caregivermediated intervention occurred over 12 weeks and primarily took place in the home. The study found greater improvement in both joint engagement and initiation of joint attention in the intervention group versus the control group (caregiver education), showing promise for shortterm caregiver-mediated interventions for families with limited resources. Implications of Occupational Therapy This study was the first large randomized controlled trial that compared two short-term community caregiver interventions among low-resourced families with children with ASD. This study found that the caregiver-mediated intervention was more effective at improving child outcomes (joint engagement, initiation of joint attention, and symbolic play) than the caregiver education. The caregiver-mediated intervention was implemented both individually and in the home, which could have contributed to the effectiveness. Researchers should consider these two variables (individual and home based) when planning future interventions for young children with ASD. Occupational therapists can be an essential part of intervention teams providing home-based parent-mediated interventions as well as building on the parent-mediated model in current practices, particularly in high-risk populations. In addition, several barriers to accessing early intervention services exist for families who are low resourced. Occupational therapists need to know how to support families in addressing these barriers to help them access appropriate services. RESEARCH OBJECTIVE(S) 1
List study objectives. Compare the effectiveness of a 12-week parent-mediated intervention with that of a 12-week parent-education program addressing joint engagement, joint attention, and types of play in young children with ASD who have low resources DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Randomized controlled trial SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. Participants were recruited from five study centers across the United States. Specific sampling techniques were not reported. An initial group of 147 families were assessed according to inclusion criteria and randomly assigned to one of the two treatment conditions. Inclusion Criteria The family qualified as being low-resourced, as defined by the U.S. Department of Housing and Urban Development, or met one of the following indicators: mother had a high school diploma or lower, unemployed primary caregiver, or family was receiving government assistance (e.g., Medicaid). Child s age between 2 and 5 years, with a mental age older than 12 months A clinical diagnosis of ASD, confirmed by the research team with the Autism Diagnosis Observation Schedule Exclusion Criteria Children with known genetic comorbidities SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 112 #/ (%) Male 93/(83%) #/ (%) Female 19/(17%) Ethnicity 39 Caucasian, 16 Hispanic, 31 African American, 9 Asian, 17 multiethnic or other Disease/disability diagnosis ASD INTERVENTION(S) AND CONTROL GROUPS Add groups if necessary Group 1: Intervention group Brief description of the intervention The Caregiver-Mediated Module (CMM) was an active coaching model that focused on increasing engagement between the child and parent during play, chore, and grooming routines. The child worked 2
with the parent during sessions. The intervention drew from the Joint Attention Symbolic Play Engagement and Regulation treatment. How many participants in the group? Where did the intervention take place? Who Delivered? How often? For how long? 60 In the participant s home Trained interventionists 1-hr sessions twice per week 12 weeks Group 2: Control group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who Delivered? How often? For how long? The Caregiver Education Module (CEM) was a small-group caregiver training. Children were not present. Each session covered material about teaching communication, managing behavior, and developing routines. 52 Various neighborhood locations, such as homes, community centers, clinics, and schools Trained interventionists 2-hr session once a week 12 weeks Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: YES NR X Comment: Co-intervention: YES NR X Timing: YES NR X Comment: Almost half of the participants had not received any intervention services before initiation of the study. However, the authors did not report other services that families and children were receiving during the course of the study that might have affected the study outcomes. Comment: The intervention was relatively short term. Site: 3
YES X Comment: For the CMM group, the intervention took place in the participant s home. For the CEM group, the intervention took place at various community locations. Differences in setting were not addressed. Use of different therapists to provide intervention: YES NR X Comment: There was no information provided about how many interventionists provided the intervention, what their backgrounds were, or how they were trained. MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Autism Diagnostic Observation Schedule To confirm an ASD diagnosis YES X YES X Before the study to determine study eligibility Measure 2: Measure 3: Mullen Scales of Early Learning To determine the child s mental age YES X YES X Before the study to determine study eligibility 10-min Caregiver Child Interaction, designed for the purpose of this study Included a standard set of toys; parents were instructed to play with their child in a typical manner. The caregiver child interaction was video recorded and coded for types of child play diversity and joint engagement between child and caregiver. YES X 4
Measure 4: Measure 5: Measure 6: YES X Pre- and posttreatment and at 3-month follow-up Caregiver adherence measures: caregiver diary and Caregiver Quality of Involvement Scale. The caregiver diary was designed for the purpose of this study. The caregiver diary was a caregiver-report measure that asked the extent to which caregivers reported using the learned strategies at home. Caregiver quality of involvement was assessed and reported by interventionists after the caregiver completed each session. YES NR X YES NR X Weekly, immediately after the intervention Early Social Communication Scales (an experimenter child videotaped session) Nonverbal communication behaviors; coded for child s joint attention initiations YES X YES NR X Pre- and posttreatment and at 3-month follow-up Structured Play Assessment Diversity of play acts (symbolic and functional) YES X YES NR X Pre- and posttreatment and at 3-month follow-up Measurement Biases 5
Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. YES X Comment: Recall or memory bias. Check yes, no, or NR, and if yes, explain. YES X Others (list and explain): Attrition bias YES X Comment: One of the outcome measures was a caregiver diary, which was used to assess caregiver fidelity. This was a self-report measure and thus subject to recall and memory bias. Comment: Thirty-five families never began treatment. Five families did not finish the intervention. Twelve families were lost at follow-up. RESULTS List key findings based on study objectives Include statistical significance where appropriate (p<0.05) Include effect size if reported Primary Outcome: Joint Engagement Both groups increased time spent in joint engagement (p <.001). The CMM group had a greater rate of improvement, and the increase was found to be clinically meaningful; the difference between groups in joint engagement had a moderate treatment effect size (Cohen s f = 0.21) and was maintained through the 3-month follow-up. Secondary Outcome: Early Social Communication Scales Initiating Joint Attention Both groups increased the frequency with which they initiated joint attention (p <.001). No between-groups differences were noted. The increases in the CMM group showed a greater rate of improvement from baseline to end of treatment. The increase for increasing joint attention in the CMM group more than doubled but had a small effect size. The effect was maintained at the 3-month follow-up. Secondary Outcome: Structured Play Assessment Functional and Symbolic Play Types Neither group had significant improvement in functional play (p =.46). Improvement in symbolic play was found to be greater in the CMM group. The difference between the groups showed a moderate effect size. Secondary Outcome: Caregiver Involvement and Adherence Both groups had high caregiver ratings of their use of strategies at home, with the CMM group reporting slightly less difficulty than the CEM group. The interventionists also rated high adherence for both groups. Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. 6
YES X Comment: Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. YES X Comment: Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. YES X Comment: Was the percent/number of subjects/participants who dropped out of the study reported? YES X Limitations: What are the overall study limitations? The interventions were relatively short term; they lasted only 12 weeks. Parents of children with ASD need consistent and long-term support to continue the intervention. A high percentage of families (15%) did not complete the intervention, and a large number of families (35) did not even begin the intervention, which could be related to a number of barriers directly pertaining to the low-resourced families. Interventions provided to a low-resourced population must address the specific needs of the group to support their participation in consistent interventions as well as research studies. Little information is provided about the interventionists who implemented the intervention or how they had been trained. The authors reported a 23-month recruitment period. Some children who could have participated might have aged out by the study s start, because there was a small inclusion age range (2 5 years) and a long recruitment window. CONCLUSIONS State the authors conclusions related to the research objectives. Improvement in joint engagement and initiation of joint attention was found in both groups, but clinically significant improvement was found in the CMM group. Initiating joint attention was maintained for both groups at the 3-month follow-up. There was a small but significant improvement of symbolic play found in the CMM group. No change was found in functional play skills for either group. The CMM intervention was found by this randomized controlled trial to be significantly more effective than the CEM intervention at improving joint engagement, initiation of joint attention, and symbolic play. This study shows evidence that although both the CEM and the CMM interventions were found 7
to be effective, the CMM intervention was more effective for improving joint engagement, initiation of joint attention, and symbolic play. On the basis of this evidence, these types of interventions with low-resourced families should be further researched and implemented. This work is based on the evidence-based literature review completed by Colleen Althoff, OTS, and Karla Ausderau, PhD, faculty advisor, University of Wisconsin Madison. CAP Worksheet adapted from Critical Review Form Quantitative Studies. Copyright 1998 by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, and M. Westmorland, McMaster University. Used with permission. 8