N/A
N=118
Mindfulness for Parents of Children With Autism Spectrum Disorder Autism Spectrum Disorder
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03459625 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Scores on a Standardized Parent-report Questionnaire. — 68.40; 66.49 t-scores
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness-Based Stress Reduction (MSBR) (Behavioral); Psychoeducational Support Group (PE) (Behavioral)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Scores on a Standardized Parent-report Questionnaire. |
68.40; 66.49 | — |
| PRIMARY Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire. |
62.03; 65.50 | — |
| PRIMARY Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire. |
62.03; 65.50 | — |
| PRIMARY Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire. |
62.03; 65.50 | — |
| SECONDARY Parenting Stress |
26.0323; 32.6154 | — |
| SECONDARY Parenting Stress |
26.0323; 32.6154 | — |
| SECONDARY Parenting Stress |
26.0323; 32.6154 | — |
| SECONDARY Parenting Stress |
26.0323; 32.6154 | — |
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.
Eligibility Criteria
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
- 5 years of age
Data sourced from ClinicalTrials.gov (NCT03459625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.