NCT05580432

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

February 9, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

1.4 years

First QC Date

October 11, 2022

Last Update Submit

August 20, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    Baseline to 12 months

  • 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

    Baseline to 12 months

Secondary Outcomes (9)

  • Change in frequency of participation by child with ASD

    Baseline to 12 months

  • Change in involvement during participation by child with ASD

    Baseline to 12 months

  • Change in parent desire for change in participation by child with ASD

    Baseline to 12 months

  • Change in environmental support for participation by child with ASD

    Baseline to 12 months

  • Change in community participation by parents

    Baseline to 12 months

  • +4 more secondary outcomes

Study Arms (2)

Immediate behavioral intervention

EXPERIMENTAL

Participants will receive the intervention immediately

Behavioral: Parenting with Positive Behavior Interventions

Delayed behavioral intervention

ACTIVE COMPARATOR

Participant will receive the intervention after a 12 month delay

Behavioral: Parenting with Positive Behavior Interventions

Interventions

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: 1. Didactic Training: Participants will view a presentation 2. Workbook/Homework: Participants will complete a guided worksheet 3. Coaching Meeting - Planning: Participants will meet with a coach who is an expert in autism and behavior 4. Coaching - Observation/ Feedback: The coach will observe parent implementing the strategy, then provide feedback and direction regarding use of technique 5. Virtual Parent Community of Support Meeting: Attend parent led community support meeting to network, share experiences and information, and exchange ideas

Delayed behavioral interventionImmediate behavioral intervention

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Lauren Avellone, PhD, BCBA, LBA

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Waitlisted control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 14, 2022

Study Start

February 9, 2023

Primary Completion

June 20, 2024

Study Completion

June 20, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations