Child Mental Disorder
Conditions
Keywords
Mental Health, Intervention
Brief summary
Depression and anxiety are major challenges to American children's optimal mental health, with already high rates exacerbated by the Covid-19 pandemic. Yet help is beyond reach for many children who do not have access to care for reasons including a severely depleted cadre of professionally trained service providers, fear of stigma that goes along with a diagnosis, low access to clinics, and lack of insurance. Without help their problems will likely accelerate and become more deleterious to their development as adolescents and young adults. The current study aims to address the lack of care by providing a program in school classrooms that will reduce children's symptoms of depression and anxiety, as well as enhance their emotion regulation and coping skills. The mental health and adjustment of two groups of children are compared and evaluated at twelve week intervals in this clinical trial - those who first participate in the Kids' Empowerment Program (KEP) and a comparison group that participates in the program after the second evaluation. Once proven to be successful, the ultimate goal of the project is to disseminate the program throughout the State of Michigan and beyond, thereby providing children with tools that will empower them to be successful in managing emotional challenges throughout their life.
Detailed description
The aim of this clinical trial is to conduct an evaluation of whether children who participate in the Kids' Empowerment Program (KEP) have fewer symptoms of depression and anxiety after 12 weeks relative to those in the comparison group. Further, the investigator seeks to identify for whom the program is most helpful and elements of the program that contribute to success. The experimental condition consists of both those who experience the KEP in-person in their classroom (n = 60) and 60 in the comparison condition. Standardized measures assess children's mental health, coping, resilience, and emotion regulation before and after 12 weeks. Those in the comparison group receive the KEP program in their classroom after the second interview. Children are interviewed at school and parents complete an online survey.
Interventions
BEHAVIORALThe Kids' Empowerment Program
The 12-session KEP provides support and information while teaching children self-management skills based on techniques derived from a combination of best, evidence-based practices (e.g., using elements of cognitive behavioral therapy, behavioral activation, brief behavioral activation, and interpersonal therapy. Adjustment is enhanced with a comprehensive approach that strengthens cognition (how to think about things), changes behavior (problem solving or planning actions), and focuses on emotions (identifying and expressing feelings), social relationships (peers, parents, siblings), and physical health (de-stressing, exercise). Group leaders follow a training manual with developmentally appropriate scripts, instructions for behavioral applications in (e.g., craft or game activities) and practice plans.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
To minimize the possibility of a breach in confidentiality, each child's and parent's information is protected with a code number that will be associated with all of their study materials instead of their name. All identifying information is stored in a separate locked cabinet in the office of Dr. Graham-Bermann. All other study materials (without names) will be kept in a locked cabinet in the research laboratory of Dr. Graham-Bermann to maintain privacy.
Intervention model description
Two groups of children and their parent will be compared and evaluated twice (twelve weeks apart). The first group (approximately half of the sample) will participate in the Kids' Empowerment Program in their classroom and their parent will complete assessments online. The second group will complete both assessments and then receive the program in their classroom after the 12 week interval.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Child age 6 to 12 years * Parent consents to participate interviews and the program * Parent agrees to two assessments
Exclusion criteria
* Child age younger than 6 and older than 12 * Child with significant developmental or cognitive delays prohibiting program participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revised Children's Anxiety and Depression Scale | Pre-intervention and 12 weeks later | Parent reported and child self-rated symptoms of child's anxiety and depression - 25 items, scored 0 to 3, with minimum score of 0 and highest score of 75. Higher scores indicate greater anxiety and depression. |
| Strengths and Difficulties Questionnaire | Pre-intervention and 12 weeks later | Parent reported and child self-rated aggression, peer problems, and pro social skills - 15 items (5 items each scale). Scoring ranges from 0 to 2. Minimum score for each scale is 0 and maximum score if 10. Higher scores indicate greater aggression, greater peer problems, and greater prosocial behavior. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Emotion Regulation Questionnaire | Pre-intervention and 12 weeks later | 36 items assessing 9 areas of emotion regulation: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination, Positive reappraisal, Putting into perspective, and Catastrophizing. Each subscale consists of 4 items, scored 1 to 4, with a possible range of 4 to 16 for each subscale. Higher scores indicate greater use of that particular emotion regulation strategy. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSandra Graham-Bernann, Ph.D.
University of Michigan
Outcome results
None listed