NCT03513419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

May 25, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

1.8 years

First QC Date

April 18, 2018

Last Update Submit

May 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, week 8

Secondary Outcomes (3)

  • Change in Acceptance and Action Questionnaire-II (AAQ-II) from Baseline to week 8

    Baseline, week 8

  • Change in Mindful Attention Awareness Scale (MAAS) from Baseline to week 8

    Baseline, week 8

  • Change in Life Orientation Test Revised (LOT-R) from Baseline to week 8

    Baseline, week 8

Study Arms (2)

AMOR Method

EXPERIMENTAL

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.

Behavioral: The AMOR Method

Wait List

NO INTERVENTION

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.

Interventions

The AMOR MethodBEHAVIORAL

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.

AMOR Method

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

April 18, 2018

First Posted

May 1, 2018

Study Start

May 25, 2018

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

May 7, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations