Improving Mental Health in School-age Children Through the Kids' Empowerment Program (KEP)

Child Mental Disorder Clinical Trial

— KEP  

Official title:

Improving Mental Health in School-age Children Through the Kids' Empowerment Program (KEP)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06354907
• Other study ID #: HUM00150780
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: October 2, 2024

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: October 2, 2024
• Est. primary completion date: October 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Mental Disorder
• Mental Disorders
• Neurodevelopmental Disorders

Intervention

Behavioral:
• The 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (7)

Beck, J. S. (2011), Cognitive behavior therapy: Basics and beyond (2nd ed.), New York, NY: The Guilford Press, pp. 19-20.

Cuijpers P, Donker T, Weissman MM, Ravitz P, Cristea IA. Interpersonal Psychotherapy for Mental Health Problems: A Comprehensive Meta-Analysis. Am J Psychiatry. 2016 Jul 1;173(7):680-7. doi: 10.1176/appi.ajp.2015.15091141. Epub 2016 Apr 1. — View Citation

Funderburk JS, Pigeon WR, Shepardson RL, Maisto SA. Brief behavioral activation intervention for depressive symptoms: Patient satisfaction, acceptability, engagement, and treatment response. Psychol Serv. 2020 Nov;17(4):443-451. doi: 10.1037/ser0000328. Epub 2019 Feb 4. — View Citation

Garnefski, Nadia, & Kraaij, V. (2007). The Cognitive Emotion Regulation Questionnaire. European Journal of Psychological Assessment, 23(3), 141-149. doi:10.1027/1015-5759.23.3.141

Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x. — View Citation

Kern ML, Benson L, Steinberg EA, Steinberg L. The EPOCH Measure of Adolescent Well-Being. Psychol Assess. 2016 May;28(5):586-97. doi: 10.1037/pas0000201. Epub 2015 Aug 24. — View Citation

Mazzucchelli, T. G. (2016). Behavioural activation: Current practice, new applications, and future directions. Clinical Psychologist, 20(1), 3-4. https://doi.org/10.1111/cp.12089

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EPOCH Questionnaire	The 20 item EPOCH is used to measure subjective well-being and includes subscales of Engagement, Perseverance, Optimism, Connectedness, and Happiness. The five subscales consist of 4 items each scored from 1 to 5. The range of scores for each subscale is from 4 to 20. Child self-report and parent report of child. Higher scores indicate greater well-being for each subscale.	Pre-intervention and 12 weeks later
Primary	Revised Children's Anxiety and Depression Scale	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.	Pre-intervention and 12 weeks later
Primary	Strengths and Difficulties Questionnaire	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.	Pre-intervention and 12 weeks later
Secondary	Cognitive Emotion Regulation Questionnaire	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.	Pre-intervention and 12 weeks later