NCT03459625: ASD

Mindfulness for Parents of Children With Autism Spectrum Disorder Autism Spectrum Disorder

Completed NA Results posted Last updated 13 November 2023

What this trial tests

NA trial testing Mindfulness-Based Stress Reduction (MSBR) in Autism Spectrum Disorder in 118 participants. Completed in 28 June 2022.

Timeline

21 July 2018

Primary endpoint
28 June 2022

28 June 2022

Quick facts

Lead sponsor	Loma Linda University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	118
Start date	21 July 2018
Primary completion	28 June 2022
Estimated completion	28 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness-Based Stress Reduction (MSBR)
• Psychoeducational Support Group (PE)

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Loma Linda University

Who can join

Adults 3 to 5, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Scores on a Standardized Parent-report Questionnaire. Primary · 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 Externali

Group	Value	95% CI
Mindfulness-Based Stress Reduction (MSBR)	68.40	± 11.335
Psychoeducational Support Group (PE)	66.49	± 11.393

Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire. Primary · 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 Externali

Group	Value	95% CI
Mindfulness-Based Stress Reduction (MSBR)	61.64	± 11.704
Psychoeducational Support Group (PE)	62.82	± 10.878

Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire. Primary · 6-month follow-up visit

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 Externali

Group	Value	95% CI
Mindfulness-Based Stress Reduction (MSBR)	61.69	± 12.148
Psychoeducational Support Group (PE)	64.07	± 9.773

Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire. Primary · 12-month follow-up visit

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 Externali

Group	Value	95% CI
Mindfulness-Based Stress Reduction (MSBR)	62.03	± 12.388
Psychoeducational Support Group (PE)	65.50	± 9.538

Parenting Stress Secondary · 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.

Group	Value	95% CI
Mindfulness-Based Stress Reduction (MSBR)	37.4717	± 9.19156
Psychoeducational Support Group (PE)	37.4340	± 8.35397

Parenting Stress Secondary · Within 4 weeks of completing last intervention session (session 8)

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.

Group	Value	95% CI
Mindfulness-Based Stress Reduction (MSBR)	28.8000	± 9.44132
Psychoeducational Support Group (PE)	33.1739	± 7.17187

Parenting Stress Secondary · 6-month follow-up visit

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.

Group	Value	95% CI
Mindfulness-Based Stress Reduction (MSBR)	27.9615	± 10.12514
Psychoeducational Support Group (PE)	32.1333	± 7.78032

Parenting Stress Secondary · 12-month follow-up visit

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.

Group	Value	95% CI
Mindfulness-Based Stress Reduction (MSBR)	26.0323	± 9.23935
Psychoeducational Support Group (PE)	32.6154	± 6.87067

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.