Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:08 PM
Study NCT ID:
NCT03300128
Status:
TERMINATED
Last Update Posted:
2024-11-26
First Post:
2017-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incredible Years Program for Parents of Children with Autism
Sponsor:
University of Maryland, Baltimore
Organization:
Study Overview
Official Title:
Evaluation of Incredible Years Parenting Program for Caregivers of Children with Autism
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IY-ASD
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:
1. Recruit approximately 105 parents and other primary caregivers to participate in either an IY-ASD or "Circle of Parents" group;
2. Measure parenting stress, parent coping mechanisms, parenting practices, and child behavior of participants and their children, at baseline and posttest (pre- and post-intervention);
3. Compare outcomes of parents completing IY-ASD versus those in "Circle of Parents" group;
4. Evaluate changes in parent and child outcomes from post-intervention to 3-month follow-up in IY-ASD participants; and,
5. Elicit information from IY-ASD participants to assess satisfaction and improve future use of IY-ASD in the ASD population.
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:
1. Recruit approximately 105 parents and other primary caregivers to participate in either an IY-ASD or "Circle of Parents" group;
2. Measure parenting stress, parent coping mechanisms, parenting practices, and child behavior of participants and their children, at baseline and posttest (pre- and post-intervention);
3. Compare outcomes of parents completing IY-ASD versus those in "Circle of Parents" group;
4. Evaluate changes in parent and child outcomes from post-intervention to 3-month follow-up in IY-ASD participants; and,
5. Elicit information from IY-ASD participants to assess satisfaction and improve future use of IY-ASD in the ASD population.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: