- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06366620
Examining the Feasibility, Acceptability, and Fidelity of Utilizing Parent Training Graduates as Peer Supports
Using Peer Coaches to Extend Behavioral Parent Training Programs in Underserved Communities
Study Overview
Status
Conditions
Intervention / Treatment
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. 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julia T Mattson, MD, PhD
- Phone Number: 206-993-1535
- Email: julia.mattson@seattlechildrens.org
Study Contact Backup
- Name: Alissa D Hemke, MD
- Phone Number: 206-993-1655
- Email: alissa.hemke@seattlechildrens.org
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98115
- Recruiting
- Seattle Children's
-
Contact:
- Doug Mason
- Phone Number: 206-987-7000
- Email: doug.mason@seattlechildrens.org
-
Principal Investigator:
- Alissa D Hemke, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FAST-B PEERS
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 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.
5-week parent behavioral management training program
|
Active Comparator: FAST-B
Parents in FAST-B group will receive standard FAST-B program with 5 weekly group sessions with clinician.
|
5-week parent behavioral management training program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Up to 6 weeks
|
Acceptability of FAST-B
Time Frame: Up to 6 weeks
|
Participant rating of FAST-B program, from 1 (poor) to 5 (excellent)
|
Up to 6 weeks
|
FAST-B PEERS support calls attended
Time Frame: Up to 6 weeks
|
Percent of peer support calls attended
|
Up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weekly Assessment of Child Behavior - P
Time Frame: Up to 6 weeks
|
Standardized parent-report measure of positive child behaviors (minimum = 0; maximum = 63), with higher scores indicating higher level of positive behaviors
|
Up to 6 weeks
|
Coping with Child Negative Emotions Scale
Time Frame: Up to 6 weeks
|
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)).
|
Up to 6 weeks
|
Strengths and Difficulties Questionnaire
Time Frame: Up to 6 weeks
|
Standardized measurement of child strengths and difficulties across behavioral domains, yielding Total Difficulties Score (minimum = 0 (best); maximum = 40 (worst).
|
Up to 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julia T Mattson, MD, PhD, Seattle Children's/University of Washington
- Principal Investigator: Alissa D Hemke, MD, Seattle Children's/University of Washington
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003416
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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