- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02378051
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
190
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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).
|
|
|
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.
|
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
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
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
Investigators
- 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
September 1, 2014
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
September 15, 2014
First Submitted That Met QC Criteria
February 26, 2015
First Posted (Estimate)
March 4, 2015
Study Record Updates
Last Update Posted (Estimate)
January 10, 2017
Last Update Submitted That Met QC Criteria
January 9, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Other Study ID 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.
Clinical Trials on Waitlist Control
-
University of Maryland, College ParkEnrolling by invitationExperimental | Waitlist ControlUnited States
-
University of the West of EnglandUnilever R&D; Nike; Laureus; Tucker Center for Research on Girls & Women in SportCompletedIntervention | Waitlist ControlUnited Kingdom
-
University of the West of EnglandUnilever R&D; Nike; Tucker Center for Research on Girls & Women in Sport (University... and other collaboratorsCompletedIntervention | Waitlist ControlUnited Kingdom
-
University of British ColumbiaCompleted
-
University of the West of EnglandUnilever R&D; Nike; Laureus; Tucker Center for Research on Girls & Women in SportCompletedIntervention | Waitlist ControlUnited Kingdom
-
University College, LondonActive, not recruitingWaitlist Control | Intervention (Training) ConditionUnited Kingdom
-
University of MinnesotaUnilever R&D; Nike; Laureus; University of West EnglandCompleted
-
The Hong Kong Polytechnic UniversityNot yet recruitingIntervention | Waitlist Control
-
University of Illinois at Urbana-ChampaignLouisiana State University Health Sciences Center in New Orleans; Colorado... and other collaboratorsCompletedIntervention 1: Resilience and Coping for Healthcare Group | Intervention 2: Resilience and Coping for Healthcare Plus Additional Services | Waitlist Control GroupUnited States, Puerto Rico
-
Virginia Polytechnic Institute and State UniversityRecruitingRELAX Telehealth Intervention | Psychoeducational Waitlist Control | EMI Smartphone App PilotUnited States
Clinical Trials on Staying Strong with Schools Intervention
-
University of Texas at AustinCompleted
-
Oregon Health and Science UniversityNational Institute on Aging (NIA)Not yet recruitingCaregiver Burden | Mild Cognitive Impairment | Health Behavior | Social Behavior | Dementia Alzheimers | Caregiver Burnout | Old Age; Dementia
-
University of WashingtonNational Institute on Drug Abuse (NIDA); Alliance for Child Welfare Excellence and other collaboratorsUnknownRelationship, Family (Foster) | Substance Use PreventionUnited States
-
Cornell UniversityTufts University; Montana State University; Bassett HealthcareCompletedObesity | Cardiovascular Disease | Overweight | Sedentary Lifestyle | Heart DiseaseUnited States
-
Pakistan Institute of Living and LearningUNODCRecruiting
-
University Hospital UlmRuhr University of Bochum; Philipps University Marburg Medical CenterNot yet recruitingPosttraumatic Stress Disorder
-
University of PittsburghCompletedAsthmaUnited States
-
Florida International UniversityNational Institute of Mental Health (NIMH); University at BuffaloCompletedAttention Deficit Hyperactivity DisorderUnited States
-
Cardenal Herrera UniversityCompletedMuscle Strength | Geriatric Assessment | Body Mass Index | Postural BalanceSpain
-
Mundipharma Research LimitedCompleted