- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03300128
Incredible Years Program for Parents of Children with Autism (IY-ASD)
Evaluation of Incredible Years Parenting Program for Caregivers of Children with Autism
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
"The Incredible Years" refers to a suite of developmentally appropriate, group-based interventions targeting parenting, children, and teachers. IY-ASD is an adapted version of the Basic parent training program, which uses a simple and low-cost format to develop skills in problem-solving coping, stress management, and communication. "The Incredible Years" has decades of evidence pointing to improved levels of parent stress, depression, and coping skills, as well as decreased negative child outcomes such as aggressive behavior in a broad array of diverse populations. The program has been used extensively in the United Kingdom and Sweden. Cost-effectiveness analyses have been performed with positive results in England. "The Incredible Years" is based on attachment theory and social learning theory.The goals of "The Incredible Years" parent intervention - communication, problem-solving, and stress management - are critically important to this population. Parents with children with special needs tend to interact with teachers, healthcare professionals, and other adults more often than parents whose children do not have disabilities. Thus, building a strong foundation early to begin to problem solve, communicate effectively, and navigate healthcare and special education systems can reduce some stress the parent might experience in the future.
The Incredible Years Parent Program for Autism Spectrum and Language Delays (IY-ASD). IY-ASD will be delivered over a 14-week period. The current research aims to rigorously test IY-ASD in a community-based setting using a randomized design. The investigators will compare IY-ASD to a usual practice, a parent support group currently offered at Onslow County Partnership for Children, "Circle of Parents." "Circle of Parents" is an open group which is led by a parent leader. These groups generally meet weekly or biweekly. Participants are encouraged to share resources and other support both during groups, and between meetings. Free childcare and meals are also offered during "Circle of Parents" meetings. Using a randomized design, the investigators will evaluate a parent intervention for caregivers of children with Autism Spectrum Disorder (ASD), compared to a parent support group. Over a four-year period, the investigators seek to:
- Recruit approximately 105 parents and other primary caregivers to participate in either an IY-ASD or "Circle of Parents" group;
- Measure parenting stress, parent coping mechanisms, parenting practices, and child behavior of participants and their children, at baseline and posttest (pre- and post-intervention);
- Compare outcomes of parents completing IY-ASD versus those in "Circle of Parents" group;
- Evaluate changes in parent and child outcomes from post-intervention to 3-month follow-up in IY-ASD participants; and,
- Elicit information from IY-ASD participants to assess satisfaction and improve future use of IY-ASD in the ASD population.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Jacksonville, North Carolina, United States, 28546
- Onslow County Partnership for Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parent or primary caregiver of a child ages 2 to 8 with an autism spectrum disorder
- Must live in Onslow County or surrounding county
Exclusion Criteria:
- Parent is younger than 18 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Incredible Years - ASD
The intervention, The Incredible Years Parent Program for Autism Spectrum and Language Delays (IY-ASD; more information is here: http://www.incredibleyears.com/programs/parent/autism-spectrum-language-delays/) is a 14-week course that meets for 2 hours every week.
Ideally, an IY-ASD group will be composed of approximately 10 parents and other primary caregivers of children who have autism.
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The IY-ASD intervention is designed for parents of children with autism spectrum disorder.
The programs uses a mix of videos, collaborative brainstorming sessions, and role plays to deliver content on child-directed play and positive discipline practices.
Other Names:
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Active Comparator: Circle of Parents
"Circle of Parents," the comparison condition, is an open parent support group led by a parent leader.
(For more information, see http://circleofparents.org/).
Participants are encouraged to share resources and other support both during groups, and between meetings.
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"Circle of Parents" is an open parent support group led by a parent leader.
Participants are encouraged to share resources and other support both during groups, and between meetings.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in child behavior
Time Frame: Change from baseline at 14 weeks and at 3 months
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Eyberg Child Behavior Inventory (ECBI) - This measure includes 36 items that assess typical problems reported by parents of conduct-disordered children.
Items are rated on intensity and problem scales; the two subscales are combined for a composite score.
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Change from baseline at 14 weeks and at 3 months
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Change in parent stress
Time Frame: Change from baseline at 14 weeks and at 3 months
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Parenting Stress Index-Short Form (PSI-SF) - The PSI Short Form (PSI/SF) is a direct derivative of the Parenting Stress Index (PSI) full-length test.
All 36 items on the Short Form are contained on the Long Form with identical wording and are written at a 5th-grade reading level, for parents of children 12 years and younger.
The PSI/SF yields a Total Stress score from three scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child.
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Change from baseline at 14 weeks and at 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in coping mechanisms
Time Frame: Change from baseline at 14 weeks and at 3 months
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Brief COPE - This measures assesses several types of coping mechanisms used to address stress.
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Change from baseline at 14 weeks and at 3 months
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Change in parenting practices
Time Frame: Change from baseline at 14 weeks and at 3 months
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Parent Practices Inventory (PPI) - This questionnaire was adapted from the Oregon Social Learning Center's (OSLC) discipline questionnaire and revised for young children.
There are 72 items assessing various subscales of parenting behavior.
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Change from baseline at 14 weeks and at 3 months
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Change in depression, anxiety, and stress
Time Frame: Change from baseline at 14 weeks and at 3 months
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The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. |
Change from baseline at 14 weeks and at 3 months
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Satisfaction survey
Time Frame: At treatment completion (approximately 14 weeks after baseline)
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This survey was developed for the Incredible Years and can be found in the Incredible Years manual.
It is not standardized.
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At treatment completion (approximately 14 weeks after baseline)
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Weekly IY-ASD evaluation
Time Frame: Weekly throughout treatment (14 weeks total)
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This survey was developed for the Incredible Years and can be found in the Incredible Years manual.
It is not standardized.
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Weekly throughout treatment (14 weeks total)
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Collaborators and Investigators
Investigators
- Principal Investigator: Sarah Dababnah, PhD, School of Social Work University of Maryland, Baltimore
Publications and helpful links
General Publications
- Reid MJ, Webster-Stratton C, Beauchaine TP. Parent training in head start: a comparison of program response among African American, Asian American, Caucasian, and Hispanic mothers. Prev Sci. 2001 Dec;2(4):209-27. doi: 10.1023/a:1013618309070.
- Axberg U, Hansson K, Broberg AG. Evaluation of the Incredible Years Series - an open study of its effects when first introduced in Sweden. Nord J Psychiatry. 2007;61(2):143-51. doi: 10.1080/08039480701226120.
- Edwards RT, Ceilleachair A, Bywater T, Hughes DA, Hutchings J. Parenting programme for parents of children at risk of developing conduct disorder: cost effectiveness analysis. BMJ. 2007 Mar 31;334(7595):682. doi: 10.1136/bmj.39126.699421.55. Epub 2007 Mar 9.
- Kim E, Cain KC, Webster-Stratton C. The preliminary effect of a parenting program for Korean American mothers: a randomized controlled experimental study. Int J Nurs Stud. 2008 Sep;45(9):1261-73. doi: 10.1016/j.ijnurstu.2007.10.002. Epub 2007 Nov 8.
- Webster-Stratton,C. (2011). The Incredible Years: Parents, teachers, and children's training series: Program content, methods, research and dissemination. Seattle, WA: Incredible Years, Inc.
- Jones K, Daley D, Hutchings J, Bywater T, Eames C. Efficacy of the Incredible Years Basic parent training programme as an early intervention for children with conduct problems and ADHD. Child Care Health Dev. 2007 Nov;33(6):749-56. doi: 10.1111/j.1365-2214.2007.00747.x.
- Melhuish EC. Parenting training improves problem behaviour in children at risk of conduct disorder. Evid Based Ment Health. 2007 Nov;10(4):125. doi: 10.1136/ebmh.10.4.125. No abstract available.
- Smith LE, Seltzer MM, Tager-Flusberg H, Greenberg JS, Carter AS. A comparative analysis of well-being and coping among mothers of toddlers and mothers of adolescents with ASD. J Autism Dev Disord. 2008 May;38(5):876-89. doi: 10.1007/s10803-007-0461-6.
- Dababnah S, Parish SL. A Comprehensive Literature Review of Randomized Controlled Trials for Parents of Young Children with Autism Spectrum Disorder. J Evid Inf Soc Work. 2016 May-Jun;13(3):277-92. doi: 10.1080/23761407.2015.1052909. Epub 2015 Jul 15.
- Dababnah S, Parish SL. Feasibility of an empirically based program for parents of preschoolers with autism spectrum disorder. Autism. 2016 Jan;20(1):85-95. doi: 10.1177/1362361314568900. Epub 2015 Feb 25.
- Dababnah S, Parish SL. Incredible Years program tailored to parents of preschoolers with autism: Pilot results. Research on Social Work Practice 26(4): 372-385. https://doi.org/10.1177/1049731514558004
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00074617
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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