NCT06578026

Brief Summary

Our study aimed to answer the question: Can a resilience-based intervention improve the psychosocial and educational outcomes of students with psychosocial difficulties? We examined the effectiveness of a resilience-based group intervention, the Resilience Builder Program® (RBP), with students in low-SES school settings to determine if this treatment improves psychosocial and educational outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

3.7 years

First QC Date

August 24, 2024

Last Update Submit

August 27, 2024

Conditions

Keywords

resilience

Outcome Measures

Primary Outcomes (1)

  • Resiliency scales for children and adolescent (RSCA)

    self-report of child's resilience; score 0-100; higher scores = stronger resilience

    1 month

Secondary Outcomes (1)

  • Behavior assessment system for children, 2nd edition (BASC)

    1 month

Other Outcomes (1)

  • Academic competence evaluation scales (ACES)

    1 month

Study Arms (2)

Treatment

EXPERIMENTAL

Received the Resilience Builder Program intervention

Behavioral: Resilience Builder Program

Control

NO INTERVENTION

Did not receive the Resilience Builder Program

Interventions

The Resilience Builder Program® group therapy will meet for one class period once a week during the semester (12 sessions). The group aims to improve resilience skills: areas such as the ability to control emotions and behavior, social skills and interactions with peers, problem-solving skills, ability to be flexible in different situations, self-esteem, and optimistic thinking. The groups involve the group leader presenting a new topic and skill, the students discussing this topic and developing strategies associated with the skill, the students practicing the skill while getting feedback from the group leader, and a period focused on self-control strategies. A letter reviewing each session will be sent home to the parent/guardian each week. Also, each child will be asked to do an assignment between weekly sessions to help him/her practice new skills.

Treatment

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • psychosocial deficits

You may not qualify if:

  • psychosis
  • extreme aggression
  • autism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montgomery County Public Schools

Rockville, Maryland, 20850, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 24, 2024

First Posted

August 29, 2024

Study Start

June 16, 2016

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

No plans to share with other researchers

Locations