Autism Disorder Clinical Trial
— APTVerified date | January 2020 |
Source | IRIS Media Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The evaluation of the program efficacy will be conducted via a randomized control study with 136 parents of children aged 3-8 who have autism. Investigators will test whether, compared to a content comparison group (CC), administration of the APT program over a 3-week intervention period (a) improves child behaviors, (b) increases perceived quality of life, (c) decreases parental stress, (d) increases positive parenting practices, and (e) increases parent knowledge of evidence-based support practices.
Status | Completed |
Enrollment | 156 |
Est. completion date | October 30, 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Parents of children aged 3-8 who have autism Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
United States | IRIS Educational Media | Eugene | Oregon |
Lead Sponsor | Collaborator |
---|---|
IRIS Media Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Child Behavior Measured by Strengths and Difficulties Questionnaire (Goodman, 1997) | Examining change over time points (T2-T1) This 25-item parent-report version of a behavioral screening questionnaire has been used with children aged 3 to 16 years of age. It assesses both positive and negative behaviors in the following domains: conduct problems, inattention-hyperactivity, emotional symptoms, peer problems, and pro-social behavior. The SDQ-P has demonstrated acceptable psychometric properties and is available in Spanish (Goodman, 2001).Total range of scores is from 0 to 50. The prosocial items are reverse scored for the total scale so that on the total scale higher scores indicate worse behaviors. | Pre (0 weeks), Post (3 weeks) | |
Primary | Family Quality of Life as Measured by Family Quality of Life Survey (Summers et al., 2005) | Examining change over time points (T2-T1) Quality of Life was measured using the Family Quality of Life survey (FQOL; Summers et al., 2005), which is a 25-item measure of the quality of life for a family raising a child with intellectual or developmental disabilities. The outcomes measured are: quality of life in the domains of parenting, emotional well-being, physical/material well-being, and disability-related supports using a 5-point scale with responses ranging from (1) very dissatisfied to (5) very satisfied. The average score on the total scale was used in the analysis. The range is from 1 to 5 with higher scores indicating more positive outcomes. | Pre (0 weeks), Post (3 weeks) | |
Primary | Parenting Scale (Arnold, O'Leary, Wolff, & Aker, 1993) | Examining change over time points (T2-T1) Parenting Practices will be assessed using the Parenting Scale (PS; Arnold, O'Leary, Wolff, & Aker, 1993) a 30-item, 7 point Likert-like scale with three subscales (laxness, over-reactivity, and hostility). The scale has internal consistency for the total scale and subscales (a = .78 and - .83 respectively) and has been evaluated for factor structure and validity (Rhoades & O'Leary, 2007). The average score on the total scale was used in the analysis with a range of 1 to 7 with lower scores indicating more positive outcomes. | Pre (0 weeks), Post (3 weeks), | |
Primary | Scales of Independent Behavior-Revised (SIB-R; Bruininks, Woodcock, Weatherman, & Hill, 1996) | Examining change over time points (T2-T1) The SBI-R is a 40-item, 7-point scale that measures 14 areas of adaptive behaviors and 8 areas of maladaptive behaviors. We used the total adaptive scale with a total range of 0 to 120 with higher scores indicating better outcomes. |
Pre (0 weeks), Post (3 weeks) | |
Secondary | Knowledge About Applied Behavior Analysis and Acceptance Commitment Training Measured by Questionnaire | Examining change over time points (T2-T1) 20 multiple choice knowledge items were developed during the project and were used to determine the extent to which participants understood basic program content, e.g., techniques parents can use to help their child master self-care routines. These included questions about the principles of behavior support (gathering information, evaluating possible reinforcers, etc.), definitions of behavioral concepts (tantrums, reinforcement, antecedent), and application of these concepts. The total score ranged from 0 to 20 with higher scores indicating better outcomes. | Pre (0 weeks), Post (3 weeks) | |
Secondary | Consumer Satisfaction Questionnaire | A 16-item scale was developed to evaluate parents' views of the feasibility, usability, and personal relevance of the program. It asked about the information taught in the program, the trainers, the website, and the other materials. The average score on these 19 items was evaluated and ranged from 1 to 6 with higher scores indicating more positive outcomes. | Follow up (6 weeks) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02461459 -
Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) Determinants in Tuberous Sclerosis Complex (TSC)
|
||
Completed |
NCT02278328 -
MEG Study of Acute STX209 Effects in ASD
|
Early Phase 1 | |
Withdrawn |
NCT01912378 -
Triadic Interactions of Families With Autism and Oxytocin
|
Phase 1 |