Autism, Autism Spectrum Disorder
Conditions
Keywords
Supportive Parenting for Anxious Childhood emotions (SPACE), Restricted Behavior
Brief summary
This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism and investigate 1) whether caregivers can learn to deliver the adapted Supportive Parenting for Anxious Childhood emotions (SPACE) intervention for IS via telehealth and 2) whether children will show greater improvement in IS behaviors.
Interventions
BEHAVIORALSupportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS)
This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism. This includes a 16 week protocol where caregivers meet weekly for one hour with a study therapist.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* 6:0 to 10:11 years at the time of consent * diagnosed with ASD (based on history, review of available medical records including diagnostic testing completed by psychologist) * IQ \> or = 75 (based on history, review of available medical records) * report three or more family accommodations for insistence on sameness based on screening measures * English-speaking parent and youth able to consistently participate in study procedures
Exclusion criteria
* children with significant hearing, language or motor impairment * unstable behavioral and pharmacological treatments (e.g., anxiety medication) to treat anxiety or IS behaviors prior to two months to the start of the study and no anticipated changes in treatments during the course of the trial * caregivers who have participated in formal SPACE training * concurrent psychosocial treatment for anxiety or Insistence on Sameness * children who have a history of prominent school refusal, self-harm, or suicidal ideation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in parent rated Dimensional Assessment of Restricted Behavior (DARB) Scores during treatment. | Screening, Baseline, Weeks 4, 8, 12, 16 and 2 month follow up | DARB scores measure restricted and repetitive behaviors with higher scores indicating greater intensity. |
| Change from baseline in clinician rated clinical global impressions scale scores during treatment. | Weeks 8, 16 and 2 month follow up | Score Range: 1 = normal, not at all ill; 7 = among the most extremely ill patients; 1 = very much informed since the initiation of treatment; 7 = very much worse since the initiation of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD). | Baseline, Week 16 and 2 month Follow up | ASC-ASD captures anxiety with higher scores indicating greater anxiety severity across the subdomains of separation anxiety, uncertainty, performance anxiety, and anxious arousal. \[Score Range: 0-72\] |
| Change in Emotion Regulation Checklist scores during treatment | Baseline, 16 week | The Emotion Regulation Checklist (ERC) is a 24-item measure of children's self-regulation completed by a caregiver. Items are rated along a continuum (1=rarely, 4=almost always). Higher scores on the Lability/Negativity sub scale indicate more difficulty managing and coping with emotions, while higher scores on the Emotion Regulation sub scale indicate better ability to self-regulate. |
| Change in Daily Living Skills Scale Scores during treatment | Baseline, 16 week, 2 month Follow up | Higher scores indicate better ability on the DLSS. \[Score Range: 0-53\] |
| Change in Open Source - Challenging Behavior scores during treatment | Baseline, 16 weeks, 2 month Follow Up | Higher levels indicate greater levels of challenging behavior and lower levels indicate improvement. |
Countries
United States
Contacts
CONTACTKari Berquist, PhD
PRINCIPAL_INVESTIGATORJennifer Phillips, PhD
Stanford University
Outcome results
None listed