NCT06366620

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

April 17, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2024

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

April 4, 2024

Last Update Submit

April 1, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Acceptability of FAST-B PEERS

    Participant rating of experience working with Peer Support, from 1 (poor) to 5 (excellent)

    Up to 6 weeks

  • Acceptability of FAST-B

    Participant rating of FAST-B program, from 1 (poor) to 5 (excellent)

    Up to 6 weeks

  • FAST-B PEERS support calls attended

    Percent of peer support calls attended

    Up to 6 weeks

Secondary Outcomes (3)

  • Weekly Assessment of Child Behavior - P

    Up to 6 weeks

  • Coping with Child Negative Emotions Scale

    Up to 6 weeks

  • Strengths and Difficulties Questionnaire

    Up to 6 weeks

Study Arms (2)

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.

Behavioral: FAST-B PEERSBehavioral: 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.

Behavioral: FAST-B (First Approach Skills Training - Behavior)

Interventions

FAST-B PEERSBEHAVIORAL

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 PEERS

5-week parent behavioral management training program

FAST-BFAST-B PEERS

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's

Seattle, Washington, 98115, United States

Location

Study Officials

  • Julia T Mattson, MD, PhD

    Seattle Children's/University of Washington

    PRINCIPAL INVESTIGATOR
  • Alissa D Hemke, MD

    Seattle Children's/University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 16, 2024

Study Start

April 17, 2024

Primary Completion

August 6, 2024

Study Completion

August 6, 2024

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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.

Locations