Clinical trial NCT05580432: Effect of Parenting With Positive Interven on Comm Inclusion for Military Connected and Dependents With Autism
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
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Waitlisted control
Primary purpose: SUPPORTIVE_CARE

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:

1. Attend (virtually or in-person) a one-hour monthly training about behavior interventions for children with autism.
2. 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.
3. 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.
4. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in frequency of child with ASD's challenging behavior
timeFrame: Baseline to 12 months
measure: Change in severity of child with ASD's challenging behavior
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Change in frequency of participation by child with ASD
timeFrame: Baseline to 12 months
measure: Change in involvement during participation by child with ASD
timeFrame: Baseline to 12 months
measure: Change in parent desire for change in participation by child with ASD
timeFrame: Baseline to 12 months
measure: Change in environmental support for participation by child with ASD
timeFrame: Baseline to 12 months
measure: Change in community participation by parents
timeFrame: Baseline to 12 months
measure: Change in parental stress
timeFrame: Baseline to 12 months
measure: Change in child's behavior
timeFrame: Baseline to 12 months
measure: Change in child's response to behavior
timeFrame: Baseline to 12 months
measure: Parental acceptability the treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Lauren Avellone, PhD, BCBA, LBA
role: PRINCIPAL_INVESTIGATOR
References: