Autism Spectrum Disorder
Conditions
Brief summary
The current study examines the efficacy of Mindfulness-Based Stress Reduction (MBSR) to reduce parenting stress, lessen parental reactivity and negativity, and decrease child externalizing behaviors among families of children with Autism Spectrum Disorder (ASD). The design is a randomized controlled trial of 138 families of preschool-aged children with ASD. Parents of children with ASD will be randomized to MBSR or to a Psychoeducational (PE) support control group matched for clinical contact and dosage (see details on interventions below). Families will participate in laboratory assessments at baseline and immediately post-treatment, as well as at 6 months and 12 months post-treatment. Measures include standardized and validated parent and teacher questionnaires, gold-standard psychological assessments, and observational and interview ratings.
Detailed description
Families of children with Autism Spectrum Disorder (ASD) experience heightened risk due to elevated rates of clinically-significant parenting stress and child externalizing behavior problems. Parenting stress is a robust predictor of subsequent externalizing challenges in children with ASD. Nonetheless, few evidenced-based treatments exist for reducing parenting stress in these families. The mechanisms through which parenting stress influence child externalizing problems are also unclear, although preliminary evidence suggests the potential role of negative parenting behaviors. This study comprehensively addresses these considerations by testing the efficacy of Mindfulness-Based Stress Reduction (MBSR) as an intervention to reduce parenting stress, lessen parental reactivity and negativity, and decrease child externalizing behaviors. MBSR is particularly well-suited for parents of children with ASD given the intervention emphasis on teaching participants to manage reactivity in the context of persistent stress. However, the efficacy of MBSR has yet to be established for this population. The present investigation extends preliminary investigations of mindfulness approaches by: 1) conducting a stringent test of MSBR using an active psychoeducational (PE) control, 2) developing population-specific content and testing the efficacy of MSBR for parents of children with ASD, 3) utilizing a highly diverse, underserved community-based sample, 4) examining the mechanisms underlying observed treatment effects, and 5) employing multi-method longitudinal measurement from multiple sources in order to examine immediate and long-term treatment effects. The current study is a randomized controlled trial of 138 families of preschool-aged children with ASD. Parents will be randomized to MBSR or to a PE support group matched for clinical contact and dosage. Families will participate in laboratory assessments at baseline and immediately post-treatment, as well as at 6 months and 12 months post-treatment. Measures include standardized and validated parent and teacher questionnaires, gold-standard psychological assessments, and observational and interview ratings. The MBSR intervention includes eight weekly 2.5-hour group sessions, a day-long (6hr) meditation retreat on the weekend during week six, 45 minutes of daily home practice guided by instructional audio CDs (portable CD players will be provided when necessary), and an MBSR parent workbook. Formal mindfulness exercises aim to increase the capacity for mindfulness (present-moment awareness with a compassionate, non-judgmental stance) and include a body scan, mindful yoga, and sitting meditation. Participants are also taught to practice mindfulness informally in everyday activities. In session, didactic instruction on stress physiology and using mindfulness for coping with stress in daily life is provided. Participants practice formal mindfulness exercises, break into dyads to discuss their daily homework practice, and meet as a larger group to ask questions related to the practice of mindfulness in everyday life. In order to provide a rigorous test of the contributions of mindfulness techniques, the current investigation will control for therapeutic effects associated with clinician contact and group support by comparing MBSR to a PE support condition matched for dosage. The PE condition also consists of 8-weekly 2.5-hour sessions, a day-long (6hr) Family Resource Fair during week six (wherein families will attend talks by professionals, explore available local resources, and meet with service providers), daily homework that includes monitoring progress on goals identified at the end of each session, and a workbook for parents of children with special needs that provides parents with information regarding their child's development, disability, and associated considerations. Establishing an efficacious stress reduction intervention to target mechanisms linking parenting stress, negative parenting behaviors, and child externalizing problems will advance clinical science and optimize outcomes for children with ASD and their families.
Interventions
MBSR includes eight weekly 2.5-hour group sessions, a day-long (6hr) meditation retreat on the weekend during week six, 45 minutes of daily home practice guided by instructional audio CDs, and an MBSR parent workbook. Formal mindfulness exercises aim to increase the capacity for mindfulness and include a body scan, mindful yoga, and sitting meditation. Participants are also taught to practice mindfulness informally in everyday activities. In session, didactic instruction on stress physiology and using mindfulness for coping with stress in daily life is provided. Participants practice formal mindfulness exercises, break into dyads to discuss their daily homework practice, and meet as a larger group to ask questions related to the practice of mindfulness in everyday life.
BEHAVIORALPsychoeducational Support Group (PE)
The PE consists of 8-weekly 2.5-hour sessions, a day-long (6hr) Family Resource Fair during week six, daily homework that includes monitoring progress on goals identified at the end of each session, and a workbook for parents of children with special needs that provides parents with information regarding their child's development, disability, and associated considerations. Weekly topics for discussion include Preparing for Individualized Education Plan (IEP) meetings, Communicating with Teachers, Advocacy, Sibling Issues, and Community Resources.
Sponsors
California State University, Fullerton
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants will participate in laboratory assessments at baseline and immediately post-treatment, as well as at 6 months and 12 months post-treatment. Measures include standardized and validated parent and teacher questionnaires, gold-standard psychological assessments, and observational and interview ratings. All assessors for laboratory assessments will remain blind to treatment group assignment for the duration of the project. Teachers will also be blind to treatment group assignment. Research assistants involved in observational coding will be blind to both treatment condition and visit time point.
Intervention model description
The proposed study is a randomized controlled trial of 138 families that will be conducted in three cohorts. Each cohort will involve a recruitment phase of 46 participants. Within each cohort parents will be randomly assigned to the MBSR (N=23) or PE group (N=23), and the groups will run concurrently.
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Child community diagnosis of ASD confirmed by study administered assessments * Age 3 to 5 years * Elevated parenting stress as indexed by a total score above the recommended cutoff at the 85th percentile on the Parenting Stress Index-4 (Abidin, 1995) * Abbreviated Battery IQ (ABIQ) score above 35 on the Stanford-Binet Intelligence Scales 5th Edition ABIQ to ensure task validity (SB5 ABIQ; Roid, 2003)
Exclusion criteria
* Positive screen for active parental psychosis, substance abuse, or suicidality according to the associated modules of the Structured Clinical Interview for DSM Disorders, SCID, Research Version Non-Patient Edition (First, Spitzer, Gibbon, & Williams, 2002) * Parent participation in an auxiliary mental health treatment or support group * \< 3 years or \> 5 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Scores on a Standardized Parent-report Questionnaire. | At baseline | Assessment will be based on reductions parent ratings on the Externalizing Problems t-score of the Child Behavior Checklist-Ages 1.5-5. The Child Behavior Checklist has 99 items that assess the degree or frequency of child behavior problems. Each item is rated on a scale of 0 (not true), 1 (somewhat or sometimes true), or 2 (very true or often true). T-scores on the Externalizing Problems sub-scale of the Child Behavior Checklist have a theoretical population mean of 50 and a standard deviation of 10. Higher scores indicating more behavior problems. A t-score between 60 and 63 on the Externalizing Problems sub-scale is considered Borderline and a t-score above 63 is considered Clinical. |
| Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire. | Within 4 weeks of completing last intervention session (session 8) | Assessment will be based on reductions parent ratings on the Externalizing Problems t-score of the Child Behavior Checklist-Ages 1.5-5. The Child Behavior Checklist has 99 items that assess the degree or frequency of child behavior problems. Each item is rated on a scale of 0 (not true), 1 (somewhat or sometimes true), or 2 (very true or often true). T-scores on the Externalizing Problems sub-scale of the Child Behavior Checklist have a theoretical population mean of 50 and a standard deviation of 10. Higher scores indicating more behavior problems. A t-score between 60 and 63 on the Externalizing Problems sub-scale is considered Borderline and a t-score above 63 is considered Clinical. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parenting Stress | Baseline | Assessment will be based in parent participant reports on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form. The Parenting Stress Index includes 36 items that are rated on a five-point scale that ranges from 1 (strongly agree) to 5 (strongly disagree). Scores on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form range from 12 to 60, with higher scores indicating more parental distress. |
Countries
United States
Participant flow
Pre-assignment details
The Protocol Enrollment (118) reflects the number of parent participants. The Total Started in Participant Flow (118) reflects the number of parent participants who were enrolled and assigned to each arm. Of note, one participant dropped out of the study and requested to not have their data used/reported. Thus, the total sample we report is N=117
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness-Based Stress Reduction (MSBR) MSBR (Kabat-Zinn, 1990), 8-week group-based intervention where participants learn mindfulness skills to help alleviate parenting stress among parents of young children with Autism Spectrum Disorder.
Mindfulness-Based Stress Reduction (MSBR): MBSR includes eight weekly 2.5-hour group sessions, a day-long (6hr) meditation retreat on the weekend during week six, 45 minutes of daily home practice guided by instructional audio CDs, and an MBSR parent workbook. Formal mindfulness exercises aim to increase the capacity for mindfulness and include a body scan, mindful yoga, and sitting meditation. Participants are also taught to practice mindfulness informally in everyday activities. In session, didactic instruction on stress physiology and using mindfulness for coping with stress in daily life is provided. Participants practice formal mindfulness exercises, break into dyads to discuss their daily homework practice, and meet as a larger group to ask questions related to the practice of mindfulness in everyday life. | 59 |
| Psychoeducational Support Group (PE) PE is a 8-week group-based intervention to provide psychosocial support and resources for parents of young children with Autism Spectrum Disorder.
Psychoeducational Support Group (PE): The PE consists of 8-weekly 2.5-hour sessions, a day-long (6hr) Family Resource Fair during week six, daily homework that includes monitoring progress on goals identified at the end of each session, and a workbook for parents of children with special needs that provides parents with information regarding their child's development, disability, and associated considerations. Weekly topics for discussion include Preparing for Individualized Education Plan (IEP) meetings, Communicating with Teachers, Advocacy, Sibling Issues, and Community Resources. | 58 |
| Total | 117 |
Baseline characteristics
| Characteristic | Mindfulness-Based Stress Reduction (MSBR) | Psychoeducational Support Group (PE) | Total |
|---|---|---|---|
| Age, Customized | 34.56 years STANDARD_DEVIATION 7.541 | 34.67 years STANDARD_DEVIATION 7.529 | 34.61 years STANDARD_DEVIATION 7.535 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 28 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 30 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 59 participants | 58 participants | 117 participants |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Male | 46 Participants | 48 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 58 |
| other Total, other adverse events | 0 / 59 | 0 / 58 |
| serious Total, serious adverse events | 0 / 59 | 0 / 58 |
Outcome results
Primary
Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire.
Assessment will be based on reductions parent ratings on the Externalizing Problems t-score of the Child Behavior Checklist-Ages 1.5-5. The Child Behavior Checklist has 99 items that assess the degree or frequency of child behavior problems. Each item is rated on a scale of 0 (not true), 1 (somewhat or sometimes true), or 2 (very true or often true). T-scores on the Externalizing Problems sub-scale of the Child Behavior Checklist have a theoretical population mean of 50 and a standard deviation of 10. Higher scores indicating more behavior problems. A t-score between 60 and 63 on the Externalizing Problems sub-scale is considered Borderline and a t-score above 63 is considered Clinical.
Time frame: Within 4 weeks of completing last intervention session (session 8)
Population: All study participants are parents of children ages 3 to 5 years with diagnosis of Autism Spectrum Disorder confirmed by study administered assessments. These participants were drawn from the Inland Empire region of Southern California.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction (MSBR) | Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire. | 61.64 units on a scale | Standard Deviation 11.704 |
| Psychoeducational Support Group (PE) | Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire. | 62.82 units on a scale | Standard Deviation 10.878 |
Primary
Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire.
Assessment will be based on reductions parent ratings on the Externalizing Problems t-score of the Child Behavior Checklist-Ages 1.5-5. The Child Behavior Checklist has 99 items that assess the degree or frequency of child behavior problems. Each item is rated on a scale of 0 (not true), 1 (somewhat or sometimes true), or 2 (very true or often true). T-scores on the Externalizing Problems sub-scale of the Child Behavior Checklist have a theoretical population mean of 50 and a standard deviation of 10. Higher scores indicating more behavior problems. A t-score between 60 and 63 on the Externalizing Problems sub-scale is considered Borderline and a t-score above 63 is considered Clinical.
Time frame: 6-month follow-up visit
Population: All study participants are parents of children ages 3 to 5 years with diagnosis of Autism Spectrum Disorder confirmed by study administered assessments. These participants were drawn from the Inland Empire region of Southern California.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction (MSBR) | Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire. | 61.69 units on a scale | Standard Deviation 12.148 |
| Psychoeducational Support Group (PE) | Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire. | 64.07 units on a scale | Standard Deviation 9.773 |
Primary
Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire.
Assessment will be based on reductions parent ratings on the Externalizing Problems t-score of the Child Behavior Checklist-Ages 1.5-5. The Child Behavior Checklist has 99 items that assess the degree or frequency of child behavior problems. Each item is rated on a scale of 0 (not true), 1 (somewhat or sometimes true), or 2 (very true or often true). T-scores on the Externalizing Problems sub-scale of the Child Behavior Checklist have a theoretical population mean of 50 and a standard deviation of 10. Higher scores indicating more behavior problems. A t-score between 60 and 63 on the Externalizing Problems sub-scale is considered Borderline and a t-score above 63 is considered Clinical.
Time frame: 12-month follow-up visit
Population: All study participants are parents of children ages 3 to 5 years with diagnosis of Autism Spectrum Disorder confirmed by study administered assessments. These participants were drawn from the Inland Empire region of Southern California.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction (MSBR) | Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire. | 62.03 units on a scale | Standard Deviation 12.388 |
| Psychoeducational Support Group (PE) | Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire. | 65.50 units on a scale | Standard Deviation 9.538 |
Primary
Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Scores on a Standardized Parent-report Questionnaire.
Assessment will be based on reductions parent ratings on the Externalizing Problems t-score of the Child Behavior Checklist-Ages 1.5-5. The Child Behavior Checklist has 99 items that assess the degree or frequency of child behavior problems. Each item is rated on a scale of 0 (not true), 1 (somewhat or sometimes true), or 2 (very true or often true). T-scores on the Externalizing Problems sub-scale of the Child Behavior Checklist have a theoretical population mean of 50 and a standard deviation of 10. Higher scores indicating more behavior problems. A t-score between 60 and 63 on the Externalizing Problems sub-scale is considered Borderline and a t-score above 63 is considered Clinical.
Time frame: At baseline
Population: All study participants are parents of children ages 3 to 5 years with diagnosis of Autism Spectrum Disorder confirmed by study administered assessments. These participants were drawn from the Inland Empire region of Southern California.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction (MSBR) | Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Scores on a Standardized Parent-report Questionnaire. | 68.40 t-scores | Standard Deviation 11.335 |
| Psychoeducational Support Group (PE) | Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Scores on a Standardized Parent-report Questionnaire. | 66.49 t-scores | Standard Deviation 11.393 |
Secondary
Parenting Stress
Assessment will be based in parent participant reports on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form. The Parenting Stress Index includes 36 items that are rated on a five-point scale that ranges from 1 (strongly agree) to 5 (strongly disagree). Scores on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form range from 12 to 60, with higher scores indicating more parental distress.
Time frame: 12-month follow-up visit
Population: All study participants are parents of children ages 3 to 5 years with diagnosis of Autism Spectrum Disorder confirmed by study administered assessments. These participants were drawn from the Inland Empire region of Southern California.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction (MSBR) | Parenting Stress | 26.0323 units on a scale | Standard Deviation 9.23935 |
| Psychoeducational Support Group (PE) | Parenting Stress | 32.6154 units on a scale | Standard Deviation 6.87067 |
Secondary
Parenting Stress
Assessment will be based in parent participant reports on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form. The Parenting Stress Index includes 36 items that are rated on a five-point scale that ranges from 1 (strongly agree) to 5 (strongly disagree). Scores on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form range from 12 to 60, with higher scores indicating more parental distress.
Time frame: Baseline
Population: All study participants are parents of children ages 3 to 5 years with diagnosis of Autism Spectrum Disorder confirmed by study administered assessments. These participants were drawn from the Inland Empire region of Southern California.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction (MSBR) | Parenting Stress | 37.4717 units on a scale | Standard Deviation 9.19156 |
| Psychoeducational Support Group (PE) | Parenting Stress | 37.4340 units on a scale | Standard Deviation 8.35397 |
Secondary
Parenting Stress
Assessment will be based in parent participant reports on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form. The Parenting Stress Index includes 36 items that are rated on a five-point scale that ranges from 1 (strongly agree) to 5 (strongly disagree). Scores on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form range from 12 to 60, with higher scores indicating more parental distress.
Time frame: Within 4 weeks of completing last intervention session (session 8)
Population: All study participants are parents of children ages 3 to 5 years with diagnosis of Autism Spectrum Disorder confirmed by study administered assessments. These participants were drawn from the Inland Empire region of Southern California.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction (MSBR) | Parenting Stress | 28.8000 units on a scale | Standard Deviation 9.44132 |
| Psychoeducational Support Group (PE) | Parenting Stress | 33.1739 units on a scale | Standard Deviation 7.17187 |
Secondary
Parenting Stress
Assessment will be based in parent participant reports on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form. The Parenting Stress Index includes 36 items that are rated on a five-point scale that ranges from 1 (strongly agree) to 5 (strongly disagree). Scores on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form range from 12 to 60, with higher scores indicating more parental distress.
Time frame: 6-month follow-up visit
Population: All study participants are parents of children ages 3 to 5 years with diagnosis of Autism Spectrum Disorder confirmed by study administered assessments. These participants were drawn from the Inland Empire region of Southern California.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction (MSBR) | Parenting Stress | 27.9615 units on a scale | Standard Deviation 10.12514 |
| Psychoeducational Support Group (PE) | Parenting Stress | 32.1333 units on a scale | Standard Deviation 7.78032 |