Child Disruptive Behavior DisordersNCT06366620
Examining the Feasibility, Acceptability, and Fidelity of Utilizing Parent Training Graduates as Peer Supports
A study testing FAST-B PEERS and FAST-B (First Approach Skills Training - Behavior) in people with Child Disruptive Behavior Disorders and Parent Child Relationship, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Disruptive behavioral disorders are common in early childhood, affecting up to 15% of preschool-aged children. Behavioral parent training programs are a first-line evidence-based treatment for child disruptive behaviors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Child Disruptive Behavior Disorders, Parent Child Relationship, Parent Management Training
- What is being tested?
- FAST-B PEERS and FAST-B (First Approach Skills Training - Behavior)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2024to 6 Aug 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent of child ages 3-6
- Parent has access to video-enabled device
- Parent is fluent in English or Spanish
- Child of parent has a score of at least 3 on conduct subscale of Strengths and Difficulties Questionnaire or at least 6 on hyperactivity subscale of Strengths and Difficulties Questionnaire
- Parent is comfortable being randomized to either standard intervention (FAST-B) or FAST-B with added FAST-B PEERS component.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Peer Coaches to Extend Behavioral Parent Training Programs in Underserved Communities
Disruptive behavioral disorders are common in early childhood, affecting up to 15% of preschool-aged children. Behavioral parent training programs are a first-line evidence-based treatment for child disruptive behaviors. There is evidence showing that (a) these programs are effective in reducing disruptive behavior and improving long-term outcomes, and (b) there is an excellent return on investment for early intervention. Nevertheless, there is limited availability of behavioral parent training programs, particularly in rural settings, due to shortages of trained clinicians. Thus, there is a pressing need for expanding the mental healthcare workforce in rural/underserved areas. The study will involve an established parent-based behavioral intervention (First Approach Skills Training for Behavior; or FAST-B) with added pilot component incorporating parents who have previously been through parent behavioral management training programs as Peer Supports.
Read the detailed description
Up to 30 (15 per group, with 2 total groups) participant families will be recruited for FAST-B Peers intervention. These participants will receive the FAST-B standard of care in the context of the research study through trained clinician on the research team. As is the current standard of clinical care, FAST-B will be delivered in 1-hour weekly sessions in group-based format via Zoom, using the standard FAST-B curriculum and caregiver workbooks (https://www.seattlechildrens.org/health-safety/classes-events/behavior-basics-class/).
In addition to standard of care, half the FAST-B participants will be randomized 1:1 to additionally receive an added pilot Peer Support component. The Peer Support curriculum was developed through an iterative process, incorporating valuable feedback from parents and guidance from a dedicated community advisory panel. Upon enrollment completion of FAST-B group, randomization will be performed via random number generator. This FAST-B Peers pilot intervention involves trained Peer Supports who will each work with 2-3 families over the course of the 5-week intervention.
Peer Supports will conduct weekly calls with families going through FAST-B intervention to review the material presented, discuss application for the family, problem-solve barriers, and reinforce the family's efforts. Peer supports will additionally receive weekly consultation (1-2 hours/week) with the clinician delivering FAST-B. After the intervention is completed, both peer supports and participant families will be asked to participate in follow-up focus groups to discuss their experience in the intervention, specifically as it relates to the work of the peer supports.
- Conditions
- Child Disruptive Behavior Disorders, Parent Child Relationship, Parent Management Training, Peer Support, Child Behavior Problems, Challenging Behavior
- Being tested
- FAST-B PEERS, FAST-B (First Approach Skills Training - Behavior)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAST-B PEERSBehavioural
FAST-B PEERS consists of trained Peer Support providing weekly check-in calls with families going through FAST-B behavioral parent training program. Peer Support are parents who have previously participated in a behavioral parent training program who have undergone 6-8 hours of additional dedicated training.
FAST-B (First Approach Skills Training - Behavior)Behavioural
5-week parent behavioral management training program
| Study group | Role | What they receive |
|---|---|---|
| FAST-B PEERS | Experimental | Parents in FAST-B PEERS group will receive standard 5-week FAST-B program as well as weekly check-in support from trained 'Peer Support' parents who have previously been through parent behavioral management training programs. Receives: Behavioral: FAST-B PEERS; Behavioral: FAST-B (First Approach Skills Training - Behavior) |
| FAST-B | Active comparator | Parents in FAST-B group will receive standard FAST-B program with 5 weekly group sessions with clinician. Receives: Behavioral: FAST-B (First Approach Skills Training - Behavior) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of FAST-B PEERS
Participant rating of experience working with Peer Support, from 1 (poor) to 5 (excellent)
Measured: Up to 6 weeks
Acceptability of FAST-B
Participant rating of FAST-B program, from 1 (poor) to 5 (excellent)
Measured: Up to 6 weeks
FAST-B PEERS support calls attended
Percent of peer support calls attended
Measured: Up to 6 weeks
Secondary outcomes (3)
Weekly Assessment of Child Behavior - P
Standardized parent-report measure of positive child behaviors (minimum = 0; maximum = 63), with higher scores indicating higher level of positive behaviors
Measured: Up to 6 weeks
Coping with Child Negative Emotions Scale
Standardized parent-report measure of parents typically respond to their child's negative emotions. Three subscales focus on positive responses: expressive encouragement, emotion-focused reactions, problem-focused reactions (minimum = 1 (worst), maximum = 7 (best)). Three subscales focus on negative responses: distress reactions, punitive reactions, minimization reactions (minimum = 1 (best), maximum = 7 (worst)).
Measured: Up to 6 weeks
Strengths and Difficulties Questionnaire
Standardized measurement of child strengths and difficulties across behavioral domains, yielding Total Difficulties Score (minimum = 0 (best); maximum = 40 (worst).
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start17 Apr 2024
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Disruptive Behavior DisordersStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia T Mattson, MD, PhD, Principal investigator, Seattle Children's/University of WashingtonAlissa D Hemke, MD, Principal investigator, Seattle Children's/University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366620
- Sponsor's protocol ID
- STUDY00003416
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Recordings of behavioral intervention sessions, peer support calls, and post-intervention focus groups will not be shared with anybody outside of approved research team members involved in coding process. Data from the pilot intervention will be shared in conference abstracts and peer-reviewed journal publications.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Peer Coaches to Extend Behavioral Parent Training Programs in Underserved Communities
- ClinicalTrials.gov ID
- NCT06366620
- Acronym / sponsor ID
- STUDY00003416
- Conditions
- Child Disruptive Behavior Disorders, Parent Child Relationship, Parent Management Training, Peer Support, Child Behavior Problems, Challenging Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 16 Apr 2024 (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.
Disruptive behavioral disorders are common in early childhood, affecting up to 15% of preschool-aged children. Behavioral parent training programs are a first-line evidence-based treatment for child disruptive behaviors. There is evidence showing that (a) these programs are effective in reducing disruptive behavior and improving long-term outcomes, and (b) there is an excellent return on investment for early intervention. Nevertheless, there is limited availability of behavioral parent training programs, particularly in rural settings, due to shortages of trained clinicians. Thus, there is a pressing need for expanding the mental healthcare workforce in rural/underserved areas. The study will involve an established parent-based behavioral intervention (First Approach Skills Training for Behavior; or FAST-B) with added pilot component incorporating parents who have previously been through parent behavioral management training programs as Peer Supports.
Detailed description
Up to 30 (15 per group, with 2 total groups) participant families will be recruited for FAST-B Peers intervention. These participants will receive the FAST-B standard of care in the context of the research study through trained clinician on the research team. As is the current standard of clinical care, FAST-B will be delivered in 1-hour weekly sessions in group-based format via Zoom, using the standard FAST-B curriculum and caregiver workbooks (https://www.seattlechildrens.org/health-safety/classes-events/behavior-basics-class/).
In addition to standard of care, half the FAST-B participants will be randomized 1:1 to additionally receive an added pilot Peer Support component. The Peer Support curriculum was developed through an iterative process, incorporating valuable feedback from parents and guidance from a dedicated community advisory panel. Upon enrollment completion of FAST-B group, randomization will be performed via random number generator. This FAST-B Peers pilot intervention involves trained Peer Supports who will each work with 2-3 families over the course of the 5-week intervention.
Peer Supports will conduct weekly calls with families going through FAST-B intervention to review the material presented, discuss application for the family, problem-solve barriers, and reinforce the family's efforts. Peer supports will additionally receive weekly consultation (1-2 hours/week) with the clinician delivering FAST-B. After the intervention is completed, both peer supports and participant families will be asked to participate in follow-up focus groups to discuss their experience in the intervention, specifically as it relates to the work of the peer supports.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAST-B PEERS | Experimental | Behavioral: FAST-B PEERS, Behavioral: FAST-B (First Approach Skills Training - Behavior)Parents in FAST-B PEERS group will receive standard 5-week FAST-B program as well as weekly check-in support from trained 'Peer Support' parents who have previously been through parent behavioral management training programs. |
| FAST-B | Active comparator | Behavioral: FAST-B (First Approach Skills Training - Behavior)Parents in FAST-B group will receive standard FAST-B program with 5 weekly group sessions with clinician. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Parent of child ages 3-6
- Parent has access to video-enabled device
- Parent is fluent in English or Spanish
- Child of parent has a score of at least 3 on conduct subscale of Strengths and Difficulties Questionnaire or at least 6 on hyperactivity subscale of Strengths and Difficulties Questionnaire
- Parent is comfortable being randomized to either standard intervention (FAST-B) or FAST-B with added FAST-B PEERS component.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| FAST-B PEERSFAST-B PEERS consists of trained Peer Support providing weekly check-in calls with families going through FAST-B behavioral parent training program. Peer Support are parents who have previously participated in a behavioral parent training program who have undergone 6-8 hours of additional dedicated training. | Behavioural | FAST-B PEERS |
| FAST-B (First Approach Skills Training - Behavior)5-week parent behavioral management training program | Behavioural | FAST-B, FAST-B PEERS |
Primary outcome
Acceptability of FAST-B PEERS
Time frame: Up to 6 weeks
Participant rating of experience working with Peer Support, from 1 (poor) to 5 (excellent)
Acceptability of FAST-B
Time frame: Up to 6 weeks
Participant rating of FAST-B program, from 1 (poor) to 5 (excellent)
FAST-B PEERS support calls attended
Time frame: Up to 6 weeks
Percent of peer support calls attended
3 secondary outcomes
Weekly Assessment of Child Behavior - P
Time frame: Up to 6 weeks
Coping with Child Negative Emotions Scale
Time frame: Up to 6 weeks
Strengths and Difficulties Questionnaire
Time frame: Up to 6 weeks
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 4 Apr 2025.
- Individual participant dataSharing planned: No. Recordings of behavioral intervention sessions, peer support calls, and post-intervention focus groups will not be shared with anybody outside of approved research team members involved in coding process. Data from the pilot intervention will be shared in conference abstracts and peer-reviewed journal publications.
Related trials for Child Disruptive Behavior Disorders
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
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Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
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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.
Julia T Mattson, MD, PhD principal investigator
Seattle Children's/University of Washington
Alissa D Hemke, MD principal investigator
Seattle Children's/University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAST-B PEERS and FAST-B (First Approach Skills Training - Behavior) in people with Child Disruptive Behavior Disorders and Parent Child Relationship, run by Seattle Children's Hospital 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 5 inclusion and 1 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 4 Apr 2025. 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?
Acceptability of FAST-B PEERS (time frame: Up to 6 weeks). The study lists 3 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 4 Apr 2025.