Mindfulness Training and Parent-coaching Interventions for Autism Spectrum Disorder

Study Overview
=================
Brief Summary
-----------------
Caregivers of children with autism spectrum disorder (ASD) report higher levels of depression and distress than caregivers of typically developing children as well as children with other developmental disabilities. The proposed work tests a novel treatment paradigm that blends Mindfulness Based Stress Reduction (MBSR) with an empirically supported and manualized parent training program (Parent-Implemented Early Start Denver Model [P-ESDM]). We hypothesize that directly treating parental distress, while simultaneously providing evidence-based parent training, may greatly enhance child-focused intervention and provide benefits that resonate across the family.

Official Title
-----------------
Does Mindfulness Training Enhance Early Evidence-based Parent-coaching Interventions for Autism Spectrum Disorder?: A Randomized Controlled Trial

Conditions
-----------------
Autism Spectrum Disorder, Parents, Stress

Intervention / Treatment
-----------------
* Behavioral: Parent-implemented Early Start Denver Model
* Behavioral: Mindfulness Based Stress Reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child has diagnosis of autism spectrum disorder Child at least 12 months of age but less than 36 months at time of consent Parent speaks and reads fluent English Exclusion Criteria: Severe child sensorimotor impairment that would impact participation in treatment

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Child-focused Treatment<br>Participants in this group participate in 12 sessions of the Parent-implemented Early Start Denver Model (P-ESDM). | Behavioral: Parent-implemented Early Start Denver Model<br>* The Parent-implemented Early Start Denver Model (P-ESDM; Rogers et al., 2012) consists of 12 consecutive sessions, each session approximately 1 hour long, that promote parental ability to support and interact with their young children with autism spectrum disorder (ASD). Intervention sessions are conducted in the clinic setting by therapists trained to fidelity by ESDM-certified parent trainers. The manualized intervention has a detailed parent-training curriculum, a specific coaching intervention method, and a therapist fidelity measure. Therapists introduce skills through descriptions, interaction, modeling, coaching, and feedback.<br>|
| Experimental: Child- and Parent-focused Treatment<br>Participants in this group participate in 12 sessions of the Parent-implemented Early Start Denver Model (P-ESDM). Parents also participate in 6 separate, individual sessions of Mindfulness Based Stress Reduction (MBSR). | Behavioral: Parent-implemented Early Start Denver Model<br>* The Parent-implemented Early Start Denver Model (P-ESDM; Rogers et al., 2012) consists of 12 consecutive sessions, each session approximately 1 hour long, that promote parental ability to support and interact with their young children with autism spectrum disorder (ASD). Intervention sessions are conducted in the clinic setting by therapists trained to fidelity by ESDM-certified parent trainers. The manualized intervention has a detailed parent-training curriculum, a specific coaching intervention method, and a therapist fidelity measure. Therapists introduce skills through descriptions, interaction, modeling, coaching, and feedback.<br>Behavioral: Mindfulness Based Stress Reduction<br>* The Mindfulness Based Stress Reduction (MBSR) protocol is derived from the work by Dykens et al. (2014), which is based on the stress reduction and relaxation program (Kabat-Zinn, 1982, 1990). In this study, it is offered as 6 weekly sessions that run concurrent with the P-ESDM intervention. Participants work one-on-one with a therapist for instruction and practice in mindfulness skills as well as discussions of stress, coping, and homework assignments.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in parental stress | The Parenting Stress Index - Short Form, Third Edition (PSI-SF; Abidin, 1995), is a 36-item measure that yields three subscale scores (Parent Child Dysfunctional Interaction, Parenting Distress, Difficult Child) used in present analyses. Each item is rated as by parents as: SA (strongly agree), A (agree), NS (not sure), D (disagree), SD (strongly disagree). Scores are converted to percentile ranks, with higher scores indicating higher levels of stress. Percentile ranks of 15-80 considered typical, and ranks of 81 and above are considered high. | Baseline to end of study (Every 6 weeks for 9 months) | 
| Change in parental depression | Parents completed the Beck Depression Inventory (BDI; Beck et al., 1984). This instrument consists of 21 items, with higher scores reflecting higher levels of symptomatology. | Baseline to end of study (Every 6 weeks for 9 months) | 
| Change in parental anxiety | Parents completed the Beck Anxiety Inventory (BAI; Beck et al., 1988). This instrument consists of 21 items, with higher scores reflecting higher levels of symptomatology. | Baseline to end of study (Every 6 weeks for 9 months) | 
| Change in parental mindfulness | . Parents completed the Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006). The FFMQ consists of 44 items that yield five subscales: Observing, Describing, Acting with Awareness, Nonreactivity, and Nonjudging. Higher scores indicate more mindfulness. | Baseline to end of study (Every 6 weeks for 9 months) | 
| Change in parent relationship quality | The Dyadic Adjustment Scale (DAS; Spanier, 1989) is a 32-item measure that assesses relationship satisfaction. It includes four subscales scored using a mix of Likert and dichotomous responses. Higher scores indicate higher relationship satisfaction. | Baseline to end of study (Every 6 weeks for 9 months) | 
| Change in parental life satisfaction | Parents completed the Satisfaction with Life Scale (SLS; Diener et al., 1984). The SLS is a 5-item measure of subjective wellbeing, with each item scored along a 7-point Likert scale (higher scores indicate more satisfaction). | Baseline to end of study (Every 6 weeks for 9 months) | 
| Change in parental sleep quality | Parents completed the Insomnia Severity Index (ISI; Bastien et al., 2011). The ISI consists of seven items scored from 0-4, with higher scores reflecting more sleep-related impairment. | Baseline to end of study (Every 6 weeks for 9 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child autism symptom severity | The Autism Diagnostic Observation Schedule - Second Edition (ADOS-2; Lord et al., 2012) is a standardized clinical observation system for use with people with developmental ages of 12 months and older. Each child completes one module based upon age and language level. This module yields a Calibrated Severity Scores (CSS; range: 1-10). Higher scores reflect higher levels of autism symptoms. | Baseline, end of treatment (12 weeks), end of study (9 months) | 
| Change in child cognitive functioning | The Mullen Scales of Early Learning (MSEL; Mullen, 1995) is a standardized developmental test for children up to age five years.57 It provides scores in four domains (Visual Reception, Fine Motor, Receptive Language, Expressive Language; M=50, SD=10) and yields an overall ability index termed the Early Learning Composite (ELC; M=100, SD=15). Higher scores reflect higher levels of abilities relative to same-aged peers. | Baseline, end of treatment (12 weeks), end of study (9 months) | 
| Change in child adaptive behavior | The Vineland Adaptive Behavior Scales - Second Edition (VABS-II; Sparrow et al., 1985), Interview Form is a semistructured interview. It yields four domain standard scores: Communication, Daily Living Skills, Socialization, and Motor Skills (M = 100, SD = 15) as well as an overall Adaptive Behavior Composite (M = 100, SD = 15). High scores reflect better developed adaptive behavior skills. | Baseline, end of treatment (12 weeks), end of study (9 months) | 
| Change in child problem behaviors | The Achenbach Child Behavior Checklist (CBCL; Achenbach, 2001) yields Internalizing, Externalizing, and Total Problem composite scores. Scores are reported as T scores, with T scores above 65 reflecting clinical significance. | Baseline, end of treatment (12 weeks), end of study (9 months) | 
| Change in child communication behaviors | The MacArthur CDI Words and Gestures (Fenson et al., 2006) provides a count of parent-reported phrases understood, vocabulary comprehension and production, and actions and gestures. Higher scores indicate more reported language skills. | Baseline, end of treatment (12 weeks), end of study (9 months) |