NCT02378051

Brief Summary

The purpose of this study is to examine whether Staying Strong With Schools, a school-based intervention to support military-connected children, will be helpful for school professionals and military parents in supporting specific needs of this population of children. As part of the partnership between three school districts in Massachusetts and the Red Sox Foundation and Massachusetts General Hospital Home Base Program, the investigators will examine the efficacy of a training delivered to these schools. The schools will be randomly divided into two groups (like a toss of a coin). Half of the schools will receive the training in 2014-2015, and the other half will be waitlisted and receive the training the following year (2015-2016). All participants (school teachers, military-connected children, and their parents) will be asked to complete questionnaires the first year. The investigators hypothesize that, compared to the control schools, at the end of the school year, SSWS schools will be associated with: (1) greater sense of competence and quality of relationships with military-connected children (MCC) among school professionals; (2) lower parental distress and increased parental sense of competence and general family functioning; and (3) increased social support, and fewer academic, emotional, and behavioral problems among MCC. The investigators hypothesize that an increase in school professionals' sense of competence in identifying and handling MCC's needs, increased quality of relationships with MCC, lower parental distress, increased parental sense of competence, and increased general family functioning will mediate the efficacy of SSWS on MCC's social support and psychosocial functioning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

10 active sites

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

Study Start

First participant enrolled

September 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

September 15, 2014

Last Update Submit

January 9, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • The Teachers' Sense of Efficacy Scale

    Teachers' Sense of Efficacy is the beliefs in their capability to make a difference in student learning, to be able to get through even to students who are difficult or unmotivated. The Teacher Sense of Efficacy Scale asks teachers to assess their capability concerning instructional strategies, student engagement, and classroom management. It will assess teachers' sense of competence in handling military-connected children's needs.

    up to two years

  • The Student-Teacher Relationship Scale

    The Student-Teacher Relationship Scale (STRS) is widely used to examine teachers' relationships with young students in terms of closeness, conflict, and dependency. It will assess the quality of teachers' relationships with military-connected children.

    up to two years

Secondary Outcomes (5)

  • Parenting Sense of Competence Scale

    up to two years

  • Depression, Anxiety and Stress Scale

    up to two years

  • McMaster Family Assessment Device

    up to two years

  • Behavior Assessment System for Children, Second Edition

    up to two years

  • Child and Adolescent Social Support Scale

    up to two years

Study Arms (2)

Staying Strong with Schools Intervention

EXPERIMENTAL

The Staying Strong with Schools Intervention includes: (a) a training of all school professionals, and (b) a year-long training and supervision of the school guidance counselor (RSL), by a Liaison-Trainer (LT).

Behavioral: Staying Strong with Schools Intervention

Waitlist Control

PLACEBO COMPARATOR

The waitlist control schools will receive an educational pamphlet outlining resources useful to support military-connected children to be distributed to all educators at the beginning of the Year 1. They will then receive the Staying Strong with Schools Intervention in Year 2.

Other: Waitlist Control

Interventions

1. On-Site Training to Raise Awareness about the Stress of Parental Deployment and Review Resources Helpful in Promoting military-connected children (MCC)'s Resilience. A 60-minute training will be delivered by our Liaison Trainer on-site to school professionals at the beginning of the school year. 2. Training and supervision of the Resilience Support Liaison (RSL). In each school receiving the Staying Strong with Schools intervention, we will train the guidance counselor to take on the role of a RSL. The RSL will develop for each MCC an individual resilience support plan that will outline the specific intervention components that will be applied for him/her.

Staying Strong with Schools Intervention

Receipt of an educational pamphlet outlining resources useful to support military-connected children distributed to all educators at the beginning of the school year.

Waitlist Control

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For school teachers: age 18 or older, employed as teacher in a participating school, willingness to participate in the intervention and able to participate in the informed consent process.
  • For military-connected children: age \< 18, and currently in grade 1 through 6, student in a participating school, at least one parent who currently serves, or had served in the military since 9/11/01, children without a participating classroom teacher will not receive teacher-rated assessments, but will not be excluded from the school based intervention, parent gives permission for child to participate.
  • For military parents: male or female, age 18 or older, parent of a child enrolled in one of the participating schools, parent or co-parent currently serves, or had served in the military since 9/11/01, parent of a military-connected child that is eligible to participate, willing to participate, and able to give informed consent, and permission to release test scores, and have their child participate in SSWS, and self-report, parental and teachers' assessments.

You may not qualify if:

  • For teachers: unable to attend the initial training, unable to participate in the informed consent process.
  • For military-connected children: decline participation, determination by the principal or teacher that participation would not be in the military-connected child's best interest for any reason.
  • For military parents: unable to participate in the informed consent process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Community Charter School

Cambridge, Massachusetts, 02141, United States

Location

East Falmouth Elementary School

East Falmouth, Massachusetts, 02536, United States

Location

Morse Pond School

Falmouth, Massachusetts, 02540, United States

Location

Mullen-Hall School

Falmouth, Massachusetts, 02540, United States

Location

North Falmouth Elementary School

Falmouth, Massachusetts, 02556, United States

Location

Hyannis West Elementary School

Hyannis, Massachusetts, 02601, United States

Location

Barnstable United Elementary School

Marstons Mills, Massachusetts, 02648, United States

Location

West Villages Elementary School

Marstons Mills, Massachusetts, 02648, United States

Location

Teaticket Elementary School

Teaticket, Massachusetts, 02536, United States

Location

West Barnstable Elementary School

West Barnstable, Massachusetts, 02668, United States

Location

Study Officials

  • T.H. Eric Bui, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
  • Bonnie Ohye, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eric Bui, MD, PhD

Study Record Dates

First Submitted

September 15, 2014

First Posted

March 4, 2015

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations