Autism Spectrum DisorderASDNCT03459625
Mindfulness for Parents of Children With Autism Spectrum Disorder Autism Spectrum Disorder
A study testing Mindfulness-Based Stress Reduction (MSBR) and Psychoeducational Support Group (PE) in people with Autism Spectrum Disorder, run by Loma Linda University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Mindfulness-Based Stress Reduction (MSBR) and Psychoeducational Support Group (PE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2018to 28 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness and Parent Stress Reduction: Improving Outcomes for Children With Autism Spectrum Disorder
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Mindfulness-Based Stress Reduction (MSBR), Psychoeducational Support Group (PE)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MSBR)Behavioural
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.
Psychoeducational Support Group (PE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction (MSBR) | Experimental | 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. Receives: Behavioral: Mindfulness-Based Stress Reduction (MSBR) |
| Psychoeducational Support Group (PE) | Active comparator | PE is a 8-week group-based intervention to provide psychosocial support and resources for parents of young children with Autism Spectrum Disorder. Receives: Behavioral: Psychoeducational Support Group (PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
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.
Measured: Within 4 weeks of completing last intervention session (session 8)
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.
Measured: 6-month follow-up visit
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.
Measured: 12-month follow-up visit
Secondary outcomes (4)
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.
Measured: Baseline
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.
Measured: Within 4 weeks of completing last intervention session (session 8)
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.
Measured: 6-month follow-up visit
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.
Measured: 12-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start21 Jul 2018
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- California State University, Fullerton, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Cameron Neece, Loma Linda University
- Investigators
- Cameron L Neece, Ph.D., Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459625
- Sponsor's protocol ID
- 5110264
- Acronym
- ASD
- Status last verified
- Nov 2023
- First submitted
- 28 Feb 2018
- Last updated
- 13 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fenning RM, Northrup JB, Baker JK, Mazefsky CA, Neece CL. Multimethod examination of change in autistic preschoolers' emotion dysregulation in the context of parenting stress intervention. J Child Psychol Psychiatry. 2026 Aug 28. doi: 10.1111/jcpp.70226. Online ahead of print.
PubMed 42665438Fenning RM, Neece CL, Sanner CM, Morrell HER. Efficacy and Implementation of Stress-Reduction Interventions for Underserved Families of Autistic Preschoolers Across In-Person and Virtual Modalities. Mindfulness (N Y). 2024 Dec;15(12):2995-3011. doi: 10.1007/s12671-023-02250-0. Epub 2023 Nov 14.
PubMed 42518628
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Parent Stress Reduction: Improving Outcomes for Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03459625
- Acronym / sponsor ID
- ASD / 5110264
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- California State University, Fullerton, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 21 Jul 2018 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Posted 13 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction (MSBR) | Experimental | Behavioral: 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. |
| Psychoeducational Support Group (PE) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mindfulness-Based Stress Reduction (MSBR) |
| 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. | Behavioural | Psychoeducational Support Group (PE) |
Primary outcome
Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Scores on a Standardized Parent-report Questionnaire.
Time frame: 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.
Time frame: 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.
Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire.
Time frame: 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 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.
Time frame: 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 Externalizing Problems sub-scale is considered Borderline and a t-score above 63 is considered Clinical.
4 secondary outcomes
Parenting Stress
Time frame: Baseline
Parenting Stress
Time frame: Within 4 weeks of completing last intervention session (session 8)
Parenting Stress
Time frame: 6-month follow-up visit
Parenting Stress
Time frame: 12-month follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42665438Fenning RM, Northrup JB, Baker JK, Mazefsky CA, Neece CL. Multimethod examination of change in autistic preschoolers' emotion dysregulation in the context of parenting stress intervention. J Child Psychol Psychiatry. 2026 Aug 28. doi: 10.1111/jcpp.70226. Online ahead of print.
- Derived from this study: PubMed 42518628Fenning RM, Neece CL, Sanner CM, Morrell HER. Efficacy and Implementation of Stress-Reduction Interventions for Underserved Families of Autistic Preschoolers Across In-Person and Virtual Modalities. Mindfulness (N Y). 2024 Dec;15(12):2995-3011. doi: 10.1007/s12671-023-02250-0. Epub 2023 Nov 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cameron L Neece, Ph.D. principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MSBR) and Psychoeducational Support Group (PE) in people with Autism Spectrum Disorder, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Scores on a Standardized Parent-report Questionnaire. (time frame: At baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03459625, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.