AutismNCT05580432
Effect of Parenting With Positive Interven on Comm Inclusion for Military Connected and Dependents With Autism
A study testing Parenting with Positive Behavior Interventions in people with Autism, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Autism
- What is being tested?
- Parenting with Positive Behavior Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2023to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: The Effect of Parenting With Positive Behavior Interventions on Community Inclusion for Military Connected and Dependent Children With Autism and Their Parents
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.
Read the 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.
- Conditions
- Autism
- Being tested
- Parenting with Positive Behavior Interventions
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting with Positive Behavior InterventionsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Immediate behavioral intervention | Experimental | Participants will receive the intervention immediately Receives: Behavioral: Parenting with Positive Behavior Interventions |
| Delayed behavioral intervention | Active comparator | Participant will receive the intervention after a 12 month delay Receives: Behavioral: Parenting with Positive Behavior Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline to 12 months
Secondary outcomes (9)
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.
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
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
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start9 Feb 2023
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Waitlisted control
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Avellone, PhD, BCBA, LBA, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580432
- Sponsor's protocol ID
- HM20025356
- Status last verified
- Aug 2024
- First submitted
- 11 Oct 2022
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Parenting With Positive Behavior Interventions on Community Inclusion for Military Connected and Dependent Children With Autism and Their Parents
- ClinicalTrials.gov ID
- NCT05580432
- Acronym / sponsor ID
- HM20025356
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlisted control
| Arm | Type | Receives |
|---|---|---|
| Immediate behavioral intervention | Experimental | Behavioral: Parenting with Positive Behavior InterventionsParticipants will receive the intervention immediately |
| Delayed behavioral intervention | Active comparator | Behavioral: Parenting with Positive Behavior InterventionsParticipant will receive the intervention after a 12 month delay |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenting with Positive Behavior InterventionsParenting 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 | Behavioural | Delayed behavioral intervention, Immediate behavioral intervention |
Primary outcome
Change in frequency of child with ASD's challenging behavior
Time frame: Baseline to 12 months
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
Time frame: Baseline to 12 months
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
9 secondary outcomes
Change in frequency of participation by child with ASD
Time frame: Baseline to 12 months
Change in involvement during participation by child with ASD
Time frame: Baseline to 12 months
Change in parent desire for change in participation by child with ASD
Time frame: Baseline to 12 months
Change in environmental support for participation by child with ASD
Time frame: Baseline to 12 months
Change in community participation by parents
Time frame: Baseline to 12 months
Change in parental stress
Time frame: Baseline to 12 months
Change in child's behavior
Time frame: Baseline to 12 months
Change in child's response to behavior
Time frame: Baseline to 12 months
Parental acceptability the treatment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Avellone, PhD, BCBA, LBA principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting with Positive Behavior Interventions in people with Autism, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of child with ASD's challenging behavior (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.