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Incredible Years Program for Parents of Children With Autism (IY-ASD)

Primary Purpose

Autism Spectrum Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incredible Years - ASD
Circle of Parents
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring autism, parenting, Incredible Years

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Onslow County Partnership for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Incredible Years - ASD

Circle of Parents

Arm Description

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.

"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.

Outcomes

Primary Outcome Measures

Change in child behavior
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.
Change in parent stress
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.

Secondary Outcome Measures

Change in coping mechanisms
Brief COPE - This measures assesses several types of coping mechanisms used to address stress.
Change in parenting practices
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.
Change in depression, anxiety, and stress
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.
Satisfaction survey
This survey was developed for the Incredible Years and can be found in the Incredible Years manual. It is not standardized.
Weekly IY-ASD evaluation
This survey was developed for the Incredible Years and can be found in the Incredible Years manual. It is not standardized.

Full Information

First Posted
September 22, 2017
Last Updated
December 30, 2019
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT03300128
Brief Title
Incredible Years Program for Parents of Children With Autism
Acronym
IY-ASD
Official Title
Evaluation of Incredible Years Parenting Program for Caregivers of Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Recruitment issues
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)

3. Sponsor/Collaborators

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

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
Early intervention for children with Autism Spectrum Disorder (ASD), particularly with parent involvement, is beneficial for both children and their families. However, few interventions have been rigorously tested which explicitly address parent and family outcomes. This study will test the effectiveness of "The Incredible Years Parent Program for Autism Spectrum and Language Delays" (IY-ASD) program for parents of children with ASD ages 2-8 in a community-based setting, compared to a parent support program, "Circle of Parents." The investigators will assess parent stress, caregiver coping, child behavior, parenting practices of participants. In addition, the investigators will report on participants' satisfaction with IY-ASD, through parent interviews and satisfaction surveys.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
autism, parenting, Incredible Years

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized 1:1 into a treatment group (IY-ASD parent training program) or comparison group ("Circle of Parents" parent support program). The 14-week parent groups will be offered twice per year. Once participants are enrolled in the study, they will complete a set of baseline measures (described in Section 5). The study coordinator will provide Dr. Dababnah a complete list of participants (unique identifiers only which do not contain identifiable information). Dr. Dababnah will randomize participants using a computer-generated randomization plan into either IY-ASD or "Circle of Parents" support group. While participants and the research team will not be blinded to group assignment, only the PI and her Research Assistant(s) at UMB will have access to the randomization plan. Dr. Dababnah and her team will review baseline measures for each period after individuals have been randomized.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Incredible Years - ASD
Arm Type
Experimental
Arm Description
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.
Arm Title
Circle of Parents
Arm Type
Active Comparator
Arm Description
"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.
Intervention Type
Behavioral
Intervention Name(s)
Incredible Years - ASD
Other Intervention Name(s)
Incredible Years
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Circle of Parents
Intervention Description
"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.
Primary Outcome Measure Information:
Title
Change in child behavior
Description
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.
Time Frame
Change from baseline at 14 weeks and at 3 months
Title
Change in parent stress
Description
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.
Time Frame
Change from baseline at 14 weeks and at 3 months
Secondary Outcome Measure Information:
Title
Change in coping mechanisms
Description
Brief COPE - This measures assesses several types of coping mechanisms used to address stress.
Time Frame
Change from baseline at 14 weeks and at 3 months
Title
Change in parenting practices
Description
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.
Time Frame
Change from baseline at 14 weeks and at 3 months
Title
Change in depression, anxiety, and stress
Description
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.
Time Frame
Change from baseline at 14 weeks and at 3 months
Title
Satisfaction survey
Description
This survey was developed for the Incredible Years and can be found in the Incredible Years manual. It is not standardized.
Time Frame
At treatment completion (approximately 14 weeks after baseline)
Title
Weekly IY-ASD evaluation
Description
This survey was developed for the Incredible Years and can be found in the Incredible Years manual. It is not standardized.
Time Frame
Weekly throughout treatment (14 weeks total)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Dababnah, PhD
Organizational Affiliation
School of Social Work University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onslow County Partnership for Children
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17454729
Citation
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.
Results Reference
background
PubMed Identifier
17350965
Citation
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.
Results Reference
background
PubMed Identifier
17996239
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
17944785
Citation
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.
Results Reference
background
PubMed Identifier
11833925
Citation
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.
Results Reference
background
PubMed Identifier
17962687
Citation
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.
Results Reference
background
PubMed Identifier
17924181
Citation
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.
Results Reference
background
PubMed Identifier
26177069
Citation
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.
Results Reference
background
PubMed Identifier
25717131
Citation
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.
Results Reference
background
Citation
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
Results Reference
background

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Incredible Years Program for Parents of Children With Autism

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