NCT03300128

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
Last Updated

November 26, 2024

Status Verified

December 1, 2019

Enrollment Period

12 months

First QC Date

September 22, 2017

Last Update Submit

November 22, 2024

Conditions

Keywords

autismparentingIncredible Years

Outcome Measures

Primary Outcomes (2)

  • 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 from baseline at 14 weeks and at 3 months

  • 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.

    Change from baseline at 14 weeks and at 3 months

Secondary Outcomes (5)

  • Change in coping mechanisms

    Change from baseline at 14 weeks and at 3 months

  • Change in parenting practices

    Change from baseline at 14 weeks and at 3 months

  • Change in depression, anxiety, and stress

    Change from baseline at 14 weeks and at 3 months

  • Satisfaction survey

    At treatment completion (approximately 14 weeks after baseline)

  • Weekly IY-ASD evaluation

    Weekly throughout treatment (14 weeks total)

Study Arms (2)

Incredible Years - ASD

EXPERIMENTAL

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.

Behavioral: Incredible Years - ASD

Circle of Parents

ACTIVE COMPARATOR

"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.

Other: Circle of Parents

Interventions

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.

Also known as: Incredible Years
Incredible Years - ASD

"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.

Circle of Parents

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parent or primary caregiver of a child ages 2 to 8 with an autism spectrum disorder
  • Must live in Onslow County or surrounding county

You may not qualify if:

  • Parent is younger than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Onslow County Partnership for Children

Jacksonville, North Carolina, 28546, United States

Location

Related Publications (11)

  • 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.

    PMID: 17454729BACKGROUND
  • 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.

    PMID: 17350965BACKGROUND
  • 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.

    PMID: 17996239BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 17944785BACKGROUND
  • 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.

    PMID: 11833925BACKGROUND
  • 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.

    PMID: 17962687BACKGROUND
  • 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.

    PMID: 17924181BACKGROUND
  • 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.

    PMID: 26177069BACKGROUND
  • 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.

    PMID: 25717131BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sarah Dababnah, PhD

    School of Social Work University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 22, 2017

First Posted

October 3, 2017

Study Start

June 1, 2017

Primary Completion

May 31, 2018

Study Completion

December 10, 2018

Last Updated

November 26, 2024

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations