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The Effect of Parenting With Positive Behavior Interventions on Community Inclusion for Military Connected and Dependent Children With Autism and Their Parents

Primary Purpose

Autism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parenting with Positive Behavior Interventions
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Parent Inclusion Criteria:

  1. Be older than 18 years
  2. a. Serve or be the partner of a person who serves (or served, in the case of a deceased member) in the military(active duty, retired, medically discharged, deceased or on reserves) b. Be connected to the military (works as a civilian on base, works as a federal employee to provide services on base, provides services to the military, or is a contractor with the military OR has an immediate family member other than the parent who lives with the child and is active duty, retired, medically discharged, deceased or on reserves)
  3. Be the parent of a child with ASD who is between the ages of 5 - 11
  4. Be able to provide consent to participate

Child inclusion criteria:

  1. Be a military dependent child (a military dependent child is a child with a parent, step-parent or guardian who is currently serving in, retired or medically discharged from the Army, Navy, Air Force, Marines, Coast Guard, or the National Guard on active duty or reserves or a parent or guardian died in service of one of the branches of military listed above.)
  2. Be a military connected child (a child whose parent works as a civilian on base, works as a federal employee to provide services on base, provides services to the military, or is a contractor with the military OR a child who has an immediate family member other than the parent who lives with the child and is active duty, retired, medically discharged, deceased or on reserves)
  3. Have a medically diagnosed and/or educational eligibility label of autism, autism spectrum disorder, or any other condition associated with autism
  4. Display challenging behavior at home or in the community.
  5. Be between the ages of 5 - 11

Exclusion Criteria:

Parent Exclusion Criteria:

  1. Be unwilling or unable to consent to participate
  2. Be unwilling or unable to provide consent for their child with ASD to participate
  3. Be unwilling or unable to participate in the intervention

Child Exclusion Criteria:

  1. Not living with the parent who is participating in the intervention
  2. Hospitalized or in residential treatment outside of the parent's home

Sites / Locations

  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate behavioral intervention

Delayed behavioral intervention

Arm Description

Participants will receive the intervention immediately

Participant will receive the intervention after a 12 month delay

Outcomes

Primary Outcome Measures

Change in frequency of child with ASD's challenging behavior
The Behavior Problems Inventory (BPI-01) records the frequency of a child with ASD's challenging behavior on a 4-point scale (never, monthly, weekly, daily). Responses for each item are summed to yield three subscale frequency scores, Self-Injurious Behavior, Stereotyped Behavior, and Aggressive/Destructive Behavior
Change in severity of child with ASD's challenging behavior
The BPI-01 records the severity of a child with ASD's challenging behavior on a 3- point scale (Mild, Moderate, Severe). Item responses are summed to yield three subscale severity scores, Self-Injurious Behavior, Stereotyped Behavior, and Aggressive/Destructive Behavior

Secondary Outcome Measures

Change in frequency of participation by child with ASD
The Participation and Environment Measure - Children and Youth (PEM-CY) records the frequency of a child's frequency of participation in everyday activities. The survey asks about 25 types of activities. Parents rate how often the child has participated in the activity over the past 4 months on an 8-point scale (never to once in the last 4 months). Item responses are summed to yield three subscale frequency scores, home, school, and community.
Change in involvement during participation by child with ASD
PEM-CY records the level of involvement during a child's participation in everyday activities. The survey asks level of involvement for 25 types of activities. Parents rate how involved the child was while participating in the activity over the past 4 months on an 5-point scale (very involved to minimally involved). Item responses are summed to yield three subscale involvement scores, home, school, and community.
Change in parent desire for change in participation by child with ASD
PEM-CY records the degree to which a parent would like a child's participation in everyday activities to change. The survey asks about 25 types of activities. Parents check all changes desired (no change desired; yes, do more often; yes, do less often; yes, be more involved; yes, be less involved). Item responses are summed to yield three subscale involvement scores, home, school, and community.
Change in environmental support for participation by child with ASD
PEM-CY records the situational resources that may help or hinder a child's participation in everyday activities. The survey asks about 45 different resources. Parents mark the degree to which resources are needed/helpful on a 4-scale. Item responses are summed to yield three subscale involvement scores, home, school, and community.
Change in community participation by parents
The Participation in Meaningful Life Roles for Parents of Children with ASD records the degree to which parents of children with ASD are able to engage in life roles that are meaningful to them, such as working a job, volunteering, interacting with family members, engaging in community recreation, etc. Parents complete this measure using a 6 point likert scale.
Change in parental stress
The Parental Stress Scale (PSS) measures parents feelings and perceptions about their relationship with their child using 17 questions. Parents rate each question from 1-strongly disagree to 5-strongly agree. Ratings are summed to yield a single score with higher numbers indicating more stress
Change in child's behavior
Parents will rate their child's behavior using the age appropriate version of the Strengths and Difficulties Questionnaire (SDQ). The survey contains 25 to 27 behaviors which parents rate as no, a little, or a lot. Scores are summed to yield a single score.
Change in child's response to behavior
Parents will rate their child's response to their own behavior using the age appropriate version of the Strengths and Difficulties Questionnaire (SDQ). The survey contains 6 questions asking about whether their behaviors are upsetting or distressing to the child. Parents rate as each question on a 4-point scale from not at all to a great deal. Scores are summed to yield a single score.
Parental acceptability the treatment
Parents will complete a survey asking them to rate the treatment program on 19 variables using a 7 point scale from negative to neutral to positive. Items will be summed to yield a program acceptability score

Full Information

First Posted
October 11, 2022
Last Updated
February 24, 2023
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT05580432
Brief Title
The Effect of Parenting With Positive Behavior Interventions on Community Inclusion for Military Connected and Dependent Children With Autism and Their Parents
Official Title
The Effect of Parenting With Positive Behavior Interventions on Community Inclusion for Military Connected and Dependent Children With Autism and Their Parents
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this research study is to find out if a training program for parents with military dependent or connected children with autism (ASD) who have challenging behavior will help those children and their families participate in more community activities. The training program, called Parenting with Positive Behavior Interventions, may help military parents learn new tools that will help their children with autism and challenging behavior attend community activities more easily.
Detailed Description
Participants will be randomly assigned (like the flip of a coin) to either immediately receive the Parenting with Positive Behavior Interventions or you will be asked to wait in a control condition for six months and then receive the same intervention. Participants have an equal chance of being assigned to any one of the groups (get the treatment immediately or wait 6 months) but will be given a chance to receive the intervention regardless within 6 months. In this study, participants will be asked to do the following things: Attend (virtually or in-person) a one-hour monthly training about behavior interventions for children with autism. Participate in two 60- minutes sessions with a behavior coach (virtually or in-person) each month to talk about a community goal they want to complete with their child. Attend an optional 60-minute meeting with other research participates each month to talk about their experience learning how to manage their child's behavior. Work with a researcher to fill out a series of questionnaires 3 times during the study. These questionnaires will ask about participants, their child's challenging behaviors, stress related to community activities with their child, and how often they participate in community activities with their child with autism and challenging behavior.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Waitlisted control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate behavioral intervention
Arm Type
Experimental
Arm Description
Participants will receive the intervention immediately
Arm Title
Delayed behavioral intervention
Arm Type
Active Comparator
Arm Description
Participant will receive the intervention after a 12 month delay
Intervention Type
Behavioral
Intervention Name(s)
Parenting with Positive Behavior Interventions
Intervention Description
Parenting with Positive Behavior Interventions is a 5 month packaged intervention. The curriculum and each element of the training and coaching program is described in detail below. Each month, participants will participate in the following five activities: Didactic Training: Participants will view a presentation Workbook/Homework: Participants will complete a guided worksheet Coaching Meeting - Planning: Participants will meet with a coach who is an expert in autism and behavior Coaching - Observation/ Feedback: The coach will observe parent implementing the strategy, then provide feedback and direction regarding use of technique Virtual Parent Community of Support Meeting: Attend parent led community support meeting to network, share experiences and information, and exchange ideas
Primary Outcome Measure Information:
Title
Change in frequency of child with ASD's challenging behavior
Description
The Behavior Problems Inventory (BPI-01) records the frequency of a child with ASD's challenging behavior on a 4-point scale (never, monthly, weekly, daily). Responses for each item are summed to yield three subscale frequency scores, Self-Injurious Behavior, Stereotyped Behavior, and Aggressive/Destructive Behavior
Time Frame
Baseline to 12 months
Title
Change in severity of child with ASD's challenging behavior
Description
The BPI-01 records the severity of a child with ASD's challenging behavior on a 3- point scale (Mild, Moderate, Severe). Item responses are summed to yield three subscale severity scores, Self-Injurious Behavior, Stereotyped Behavior, and Aggressive/Destructive Behavior
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Change in frequency of participation by child with ASD
Description
The Participation and Environment Measure - Children and Youth (PEM-CY) records the frequency of a child's frequency of participation in everyday activities. The survey asks about 25 types of activities. Parents rate how often the child has participated in the activity over the past 4 months on an 8-point scale (never to once in the last 4 months). Item responses are summed to yield three subscale frequency scores, home, school, and community.
Time Frame
Baseline to 12 months
Title
Change in involvement during participation by child with ASD
Description
PEM-CY records the level of involvement during a child's participation in everyday activities. The survey asks level of involvement for 25 types of activities. Parents rate how involved the child was while participating in the activity over the past 4 months on an 5-point scale (very involved to minimally involved). Item responses are summed to yield three subscale involvement scores, home, school, and community.
Time Frame
Baseline to 12 months
Title
Change in parent desire for change in participation by child with ASD
Description
PEM-CY records the degree to which a parent would like a child's participation in everyday activities to change. The survey asks about 25 types of activities. Parents check all changes desired (no change desired; yes, do more often; yes, do less often; yes, be more involved; yes, be less involved). Item responses are summed to yield three subscale involvement scores, home, school, and community.
Time Frame
Baseline to 12 months
Title
Change in environmental support for participation by child with ASD
Description
PEM-CY records the situational resources that may help or hinder a child's participation in everyday activities. The survey asks about 45 different resources. Parents mark the degree to which resources are needed/helpful on a 4-scale. Item responses are summed to yield three subscale involvement scores, home, school, and community.
Time Frame
Baseline to 12 months
Title
Change in community participation by parents
Description
The Participation in Meaningful Life Roles for Parents of Children with ASD records the degree to which parents of children with ASD are able to engage in life roles that are meaningful to them, such as working a job, volunteering, interacting with family members, engaging in community recreation, etc. Parents complete this measure using a 6 point likert scale.
Time Frame
Baseline to 12 months
Title
Change in parental stress
Description
The Parental Stress Scale (PSS) measures parents feelings and perceptions about their relationship with their child using 17 questions. Parents rate each question from 1-strongly disagree to 5-strongly agree. Ratings are summed to yield a single score with higher numbers indicating more stress
Time Frame
Baseline to 12 months
Title
Change in child's behavior
Description
Parents will rate their child's behavior using the age appropriate version of the Strengths and Difficulties Questionnaire (SDQ). The survey contains 25 to 27 behaviors which parents rate as no, a little, or a lot. Scores are summed to yield a single score.
Time Frame
Baseline to 12 months
Title
Change in child's response to behavior
Description
Parents will rate their child's response to their own behavior using the age appropriate version of the Strengths and Difficulties Questionnaire (SDQ). The survey contains 6 questions asking about whether their behaviors are upsetting or distressing to the child. Parents rate as each question on a 4-point scale from not at all to a great deal. Scores are summed to yield a single score.
Time Frame
Baseline to 12 months
Title
Parental acceptability the treatment
Description
Parents will complete a survey asking them to rate the treatment program on 19 variables using a 7 point scale from negative to neutral to positive. Items will be summed to yield a program acceptability score
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parent Inclusion Criteria: Be older than 18 years a. Serve or be the partner of a person who serves (or served, in the case of a deceased member) in the military(active duty, retired, medically discharged, deceased or on reserves) b. Be connected to the military (works as a civilian on base, works as a federal employee to provide services on base, provides services to the military, or is a contractor with the military OR has an immediate family member other than the parent who lives with the child and is active duty, retired, medically discharged, deceased or on reserves) Be the parent of a child with ASD who is between the ages of 5 - 11 Be able to provide consent to participate Child inclusion criteria: Be a military dependent child (a military dependent child is a child with a parent, step-parent or guardian who is currently serving in, retired or medically discharged from the Army, Navy, Air Force, Marines, Coast Guard, or the National Guard on active duty or reserves or a parent or guardian died in service of one of the branches of military listed above.) Be a military connected child (a child whose parent works as a civilian on base, works as a federal employee to provide services on base, provides services to the military, or is a contractor with the military OR a child who has an immediate family member other than the parent who lives with the child and is active duty, retired, medically discharged, deceased or on reserves) Have a medically diagnosed and/or educational eligibility label of autism, autism spectrum disorder, or any other condition associated with autism Display challenging behavior at home or in the community. Be between the ages of 5 - 11 Exclusion Criteria: Parent Exclusion Criteria: Be unwilling or unable to consent to participate Be unwilling or unable to provide consent for their child with ASD to participate Be unwilling or unable to participate in the intervention Child Exclusion Criteria: Not living with the parent who is participating in the intervention Hospitalized or in residential treatment outside of the parent's home
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Avellone, PhD, BCBA, LBA
Phone
(804) 827-0756
Email
leavellone@vcu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carol M Schall, PhD
Phone
(804)828-6979
Email
cmschall@vcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Avellone, PhD, BCBA, LBA
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Parenting With Positive Behavior Interventions on Community Inclusion for Military Connected and Dependent Children With Autism and Their Parents

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