Staying Strong With Schools - A School-Based Resilience Support Intervention for Military-Connected Children

January 9, 2017 updated by: Eric Bui, MD, PhD, Massachusetts General Hospital

Staying Strong With Schools - A School-Based Resilience Support Intervention for Military-Connected Children: A Preliminary Examination of Efficacy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02141
        • Community Charter School
      • East Falmouth, Massachusetts, United States, 02536
        • East Falmouth Elementary School
      • Falmouth, Massachusetts, United States, 02540
        • Morse Pond School
      • Falmouth, Massachusetts, United States, 02540
        • Mullen-Hall School
      • Falmouth, Massachusetts, United States, 02556
        • North Falmouth Elementary School
      • Hyannis, Massachusetts, United States, 02601
        • Hyannis West Elementary School
      • Marstons Mills, Massachusetts, United States, 02648
        • Barnstable United Elementary School
      • Marstons Mills, Massachusetts, United States, 02648
        • West Villages Elementary School
      • Teaticket, Massachusetts, United States, 02536
        • Teaticket Elementary School
      • West Barnstable, Massachusetts, United States, 02668
        • West Barnstable Elementary School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Staying Strong with Schools Intervention
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
  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.
Placebo Comparator: Waitlist Control
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
Receipt of an educational pamphlet outlining resources useful to support military-connected children distributed to all educators at the beginning of the school year.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Teachers' Sense of Efficacy Scale
Time Frame: up to two years
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
Time Frame: up to two years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parenting Sense of Competence Scale
Time Frame: up to two years
The Parenting Sense of Competence scale measures parental competence on two dimensions: Satisfaction and Efficacy. It is a 16 item Likert-scale questionnaire (on a 6 point scale ranging from strongly agree [1] to strongly disagree [6]), with nine questions under Satisfaction and seven under Efficacy. Satisfaction section examines the parents' anxiety, motivation and frustration, while the Efficacy section looks at the parents' competence, capability levels, and problem-solving abilities in their parental role.
up to two years
Depression, Anxiety and Stress Scale
Time Frame: up to two years
Parental distress will be assessed using the 21-item self-report Depression, Anxiety and Stress Scale. Items each reflect a negative emotional symptom. Each of these is rated on a four-point Likert scale of frequency or severity of the participants' experiences over the last week with the intention of emphasizing states over traits. These scores ranged from 0, meaning that the client believed the item "did not apply to them at all", to 3 meaning that the client considered the item to "apply to them very much, or most of the time".
up to two years
McMaster Family Assessment Device
Time Frame: up to two years
Family functioning will be assessed using the general functioning subscale of McMaster Family Assessment Device. The GF subscale consists of 12 questions to permit individuals to rate how well each statement describes their family by selecting among four responses: strongly agree, agree, disagree, strongly disagree.
up to two years
Behavior Assessment System for Children, Second Edition
Time Frame: up to two years
Maladaptive and adaptive behaviors and self-perceptions will be assessed using the Behavior Assessment System for Children, Second Edition. In this study, parents will be the informants. This measure assesses child's behaviors in the school setting (Teacher Rating; TRS) as well as the home and community setting (Parent Rating; PRS) without substantial burden.
up to two years
Child and Adolescent Social Support Scale
Time Frame: up to two years
Perceived social support will be assessed using the Child and Adolescent Social Support Scale. Subjects respond to items using a six-point scale, ranging from 1= "never," to 6 ="always."
up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: T.H. Eric Bui, MD, PhD, Massachusetts General Hospital
  • Principal Investigator: Bonnie Ohye, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014P000867

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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