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The AMOR Method: Resilience Training for Parents of Children With Autism

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The AMOR Method
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Parents eligible to participate include parents: a) English-speaking, b) of a child aged 4:0 to 10:11 years, c) with a previous diagnosis of ASD and evidence of current social impairment (SRS-2) and repetitive behaviors (RBS-R), and d) who are able to consistently participate in sessions. Given budgetary constraints, direct diagnostic testing will not be feasible. Instead, child diagnostic status will be confirmed through review of the child's medical record for evidence that the child previously met ADOS criteria for ASD and shows clinically significant social impairment at baseline (SRS-2 T>65).

Parents who are not eligible to participate include parents: a) with severe psychiatric, genetic, or medical disorder among parents and/or children, b) taking psychiatric medication, and c) with elevated resilience scores at baseline (Total Score >80 on CD-RISC). The DSM-5 CCSM will be administered to parents to screen for parent mental illness. Any identified issues on the DSM-5 CCSM will be investigated further by the PI to rule out severe psychiatric disorders.

Exclusion Criteria:

a) Severe psychiatric, genetic, or medical disorder among parents and/or children, b) parents taking psychiatric medication, and c) parents with elevated resilience scores at baseline (Total Score>80 on CD-RISC). The DSM-5 Cross Cutting Symptom Measure (DSM-5 CCSM) will be administered to parents to screen for parent mental illness. Any identified issues on the DSM-5 CCSM will be investigated further by the PI to rule out severe psychiatric disorders. These families will be referred for behavioral consultation (available in our clinic) and then be reconsidered for group participation.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AMOR Method

Wait List

Arm Description

The AMOR Method: The parent resilience training involves a series of eight weekly 90-minute group sessions, as well as three individual sessions. Group session content includes training in mindfulness, grief and loss processing, acceptance and committed actions, optimistic thinking, and resilience through the use of didactic training, group discussions, and homework assignments. Individual session content will center on additional and individualized training in grief and loss processing, optimistic thinking, and maintaining resilience over time.

Participants assigned to the waitlist will continue stable treatments and will be offered the opportunity to participate in the treatment after completion of the 8-week trial.

Outcomes

Primary Outcome Measures

Change in Connor-Davidson Resilience Scale (CDRISC) from Baseline to week 8
No subscales, total score only, 25 items total, 0-4 Likert Score Range: 0-100 Low resilience score (PTSD & grief populations) = 45 or lower; Average/Normal resilience score (general population) = 45-80; High Average/Elevated resilience score (yogi & meditation teachers) = 81-100 Higher total scores reflect higher levels of resilience.

Secondary Outcome Measures

Change in Acceptance and Action Questionnaire-II (AAQ-II) from Baseline to week 8
No subscales, total score only, 10 items total (3 items reverse scored) Score Range: 0-70 Low acceptance 0-22, Medium 23-47, High 48-70 Higher total scores reflect higher levels of optimism.
Change in Mindful Attention Awareness Scale (MAAS) from Baseline to week 8
No subscales, total score only, 15 items total Score Range: 15-90 Low mindfulness score = 30 or lower; Average/Normal mindfulness score = 30-45-60; High Average/Elevated mindfulness score = 60 or higher Higher total scores reflect higher levels of dispositional mindfulness.
Change in Life Orientation Test Revised (LOT-R) from Baseline to week 8
No subscales, total score only, 10 items total Score Range: 0-24 Low optimism 0-8, Medium/Average Optimism 9-16, High Optimism 17-24 Higher total scores reflect higher levels of optimism.

Full Information

First Posted
April 18, 2018
Last Updated
May 6, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03513419
Brief Title
The AMOR Method: Resilience Training for Parents of Children With Autism
Official Title
The AMOR Method: Resilience Training for Parents of Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 25, 2018 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
We will evaluate whether a resilience training program which includes group and individual parent training will be effective in improving optimism and resiliency in parents of young children with autism spectrum disorders (ASD). By observing the level of parent optimism and resiliency before and after intervention, we will be able to determine whether the intervention is effective in improving parent resilience.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMOR Method
Arm Type
Experimental
Arm Description
The AMOR Method: The parent resilience training involves a series of eight weekly 90-minute group sessions, as well as three individual sessions. Group session content includes training in mindfulness, grief and loss processing, acceptance and committed actions, optimistic thinking, and resilience through the use of didactic training, group discussions, and homework assignments. Individual session content will center on additional and individualized training in grief and loss processing, optimistic thinking, and maintaining resilience over time.
Arm Title
Wait List
Arm Type
No Intervention
Arm Description
Participants assigned to the waitlist will continue stable treatments and will be offered the opportunity to participate in the treatment after completion of the 8-week trial.
Intervention Type
Behavioral
Intervention Name(s)
The AMOR Method
Intervention Description
The parent resilience training involves a series of eight weekly 90-minute group sessions with up to 8 parents of young children with ASD (4- 10:11 years old) per group, as well as three individual sessions.
Primary Outcome Measure Information:
Title
Change in Connor-Davidson Resilience Scale (CDRISC) from Baseline to week 8
Description
No subscales, total score only, 25 items total, 0-4 Likert Score Range: 0-100 Low resilience score (PTSD & grief populations) = 45 or lower; Average/Normal resilience score (general population) = 45-80; High Average/Elevated resilience score (yogi & meditation teachers) = 81-100 Higher total scores reflect higher levels of resilience.
Time Frame
Baseline, week 8
Secondary Outcome Measure Information:
Title
Change in Acceptance and Action Questionnaire-II (AAQ-II) from Baseline to week 8
Description
No subscales, total score only, 10 items total (3 items reverse scored) Score Range: 0-70 Low acceptance 0-22, Medium 23-47, High 48-70 Higher total scores reflect higher levels of optimism.
Time Frame
Baseline, week 8
Title
Change in Mindful Attention Awareness Scale (MAAS) from Baseline to week 8
Description
No subscales, total score only, 15 items total Score Range: 15-90 Low mindfulness score = 30 or lower; Average/Normal mindfulness score = 30-45-60; High Average/Elevated mindfulness score = 60 or higher Higher total scores reflect higher levels of dispositional mindfulness.
Time Frame
Baseline, week 8
Title
Change in Life Orientation Test Revised (LOT-R) from Baseline to week 8
Description
No subscales, total score only, 10 items total Score Range: 0-24 Low optimism 0-8, Medium/Average Optimism 9-16, High Optimism 17-24 Higher total scores reflect higher levels of optimism.
Time Frame
Baseline, week 8

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parents eligible to participate include parents: a) English-speaking, b) of a child aged 4:0 to 10:11 years, c) with a previous diagnosis of ASD and evidence of current social impairment (SRS-2) and repetitive behaviors (RBS-R), and d) who are able to consistently participate in sessions. Given budgetary constraints, direct diagnostic testing will not be feasible. Instead, child diagnostic status will be confirmed through review of the child's medical record for evidence that the child previously met ADOS criteria for ASD and shows clinically significant social impairment at baseline (SRS-2 T>65). Parents who are not eligible to participate include parents: a) with severe psychiatric, genetic, or medical disorder among parents and/or children, b) taking psychiatric medication, and c) with elevated resilience scores at baseline (Total Score >80 on CD-RISC). The DSM-5 CCSM will be administered to parents to screen for parent mental illness. Any identified issues on the DSM-5 CCSM will be investigated further by the PI to rule out severe psychiatric disorders. Exclusion Criteria: a) Severe psychiatric, genetic, or medical disorder among parents and/or children, b) parents taking psychiatric medication, and c) parents with elevated resilience scores at baseline (Total Score>80 on CD-RISC). The DSM-5 Cross Cutting Symptom Measure (DSM-5 CCSM) will be administered to parents to screen for parent mental illness. Any identified issues on the DSM-5 CCSM will be investigated further by the PI to rule out severe psychiatric disorders. These families will be referred for behavioral consultation (available in our clinic) and then be reconsidered for group participation.
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33774741
Citation
Schwartzman JM, Millan ME, Uljarevic M, Gengoux GW. Resilience Intervention for Parents of Children with Autism: Findings from a Randomized Controlled Trial of the AMOR Method. J Autism Dev Disord. 2022 Feb;52(2):738-757. doi: 10.1007/s10803-021-04977-y. Epub 2021 Mar 28.
Results Reference
derived

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The AMOR Method: Resilience Training for Parents of Children With Autism

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