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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06366620
Other study ID # STUDY00003416
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 10, 2024
Est. completion date June 19, 2024

Study information

Verified date April 2024
Source Seattle Children's Hospital
Contact Julia T Mattson, MD, PhD
Phone 206-993-1535
Email julia.mattson@seattlechildrens.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 19, 2024
Est. primary completion date June 19, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
FAST-B PEERS
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)
5-week parent behavioral management training program

Locations

Country Name City State
United States Seattle Children's Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability of FAST-B PEERS Participant rating of experience working with Peer Support, from 1 (poor) to 5 (excellent) Up to 6 weeks
Primary Acceptability of FAST-B Participant rating of FAST-B program, from 1 (poor) to 5 (excellent) Up to 6 weeks
Primary FAST-B PEERS support calls attended Percent of peer support calls attended Up to 6 weeks
Secondary 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 Up to 6 weeks
Secondary 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)). Up to 6 weeks
Secondary Strengths and Difficulties Questionnaire Standardized measurement of child strengths and difficulties across behavioral domains, yielding Total Difficulties Score (minimum = 0 (best); maximum = 40 (worst). Up to 6 weeks
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