Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-14
SponsorUniversity of Illinois at Urbana-Champaign

About this trial

Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported prevention interventions are needed to prevent the onset of mental and behavioral health issues among these children. Building on our preliminary findings, the proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing behavioral health and interpersonal problems among racial and ethnic minority children who live in low-resource high poverty communities.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

child experienced the COVID-19 pandemic and an additional large-scale disaster

child score is 5 or above on the Strengths and Difficulties Questionnaire

child is in 3- 8th grade at enrollment

the parent or guardian must complete informed consent and child assent

Disqualifiers

child is currently receiving treatment for a diagnosed mental health condition

children who are not able to interact with other students in a group work format, regardless of IEP status

Trial design

Design model

Parallel

Treatments tested in this trial

  • JoH-C19

    Behavioral

    Journey of Hope- COVID 19 (JoH-C19) includes eight, 1-hour consecutive sessions delivered in groups of 8 children during the school day and in after school settings. The 1.5 hour JoH-C19 caregiver workshop is delivered with groups of 8 parents prior to the child JoH-C19 curriculum

  • Switch off Get Active

    Behavioral

    Switch off Get Active covers 4 topics, and its eight, 1- hour sessions are delivered in groups of 8 children. The 1.5 hour Switch Off Get Active caregiver workshop is delivered with groups of 8 parents prior to the Switch off Get Active child curriculum

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: JoH-C19Experimental treatment 1 intervention
Group B: Switch off Get ActiveActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in Responses to Strengths and Difficulties Questionnaire

Measures children's psychological symptoms and impairments used for children between the ages of 4 to 16. The questionnaire is both parent and youth report and is comprised of five subscales including emotional symptoms, conduct problems, hyperactivity, peer relationship problems, and prosocial behavior. Total difficulty scores which include emotional symptoms, conduct problems, hyper-activity and peer relationship problems subscales range from 0-40. The pro-social behavior subscale ranges from 0-10.

Time frame
T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
2

Changes in Responses to Pediatric Symptom Checklist-Externalizing Subscale

Parent report measure of emotional and behavioral problems in children. The questionnaire is comprised of three subscales: internalizing, attention, and externalizing. The externalizing subscale will be used for this study. This subscale includes 7-items and the subscale scores range from 0-14.

Time frame
T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).

Secondary outcomes

1

Changes in Responses to Revised Children's Anxiety and Depression Scale-25 (and Subscales) (RCADS)

The Revised Child Anxiety and Depression Scale-25 (RCADS-25) includes 25-items and has both youth self-report and parent report questionnaires. The RCADS-25 is scored on a four point scale from 1-never to 4=Always. Subscales include depression and broad anxiety. The broad anxiety subscale includes 15 items and scores range from 15-60. The depression subscale includes 10-items and scores range from 10-40.

Time frame
T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
2

Changes in Responses to Family Functioning Systematic Clinical Outcome Routine Evaluation (SCORE-15)

The SCORE-15 has both youth self-report and parent report measures assessing family functioning.The measure is scored on a five-point scale from 1-describes us very well to 5-describes us not at all. Subscales include: Strength and Adaptability which includes 5-items with scores range from 5-25, Overwhelmed by Difficulties which includes 5-items with scores ranging from 5-25, and Disrupted Communication which includes 5-items with scores ranging from 5-25.

Time frame
T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
3

Changes in Responses to Healthy Pathways Academic Performance Report Academic Subscale

Assesses unidimensional aspects of illness, well-being, and health in youth in transition from childhood to adolescence. the parent-report academic subscale which includes 5-items will be used in this study. The first item inquires how the parent describes the child's grades in schools and ranges from 1=Below Average, D's or F's to 5=Excellent, A's. Items 2-5 ranges from 1=Poor to 5=Excellent. Scale scores on items 2-5 range from 4-20.

Time frame
T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
4

Changes in Responses to PROMIS Pediatric items (peer relationships)

Assesses the quality of peer relationships and is both parent and child report. The child report version 8-questions with each item ranging from 0=Never to 4=Almost Always. Raw scores range from 0-32. The parent report version consists of 7 questions with each item ranging from 1=Never to 5=Almost Always. Summed scores range from 8-40 with 8 indicating the lowest quality of peer relationships and 40 indicating the highest quality of peer relationships.

Time frame
T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).

Other outcomes

1

Changes in Responses to Social Support Questionnaire (SSQ) for Children

The SSQ is a child report measure children aged 8-18 years of age with five factors representing distinct sources of supports including: parents, relatives, non-relative adults, siblings and peers. This study will include two subscales measuring sources of support from parents and from peers. Each subscale consists of 12 questions and is measured on a 5-point Likert scale ranging from 1=Never to 6=Always. Scores for each subscale range from 12-72 with lower scores indicating less perceived support.

Time frame
T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
2

Changes in Responses to Children's Coping Strategies checklist

Assesses respondents use of a variety of strategies to cope with challenging live events. Subscales in this study include: problem focused coping, positive cognitive restructuring, avoidance, and support seeking

Time frame
T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
3

Changes in Responses to Child Self Efficacy Scale

A child-report measure for school-aged children measuring perceived self-efficacy. Subscales for this study will include self-efficacy in enlisting social resources (3-items) and social self-efficacy (3-items). Children are asked to rate their degree of confidence in each question ranging from 0=Cannot do at all to 100 Certainly can do. Scores on each subscale range from 0-300.

Time frame
T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
4

Changes in Responses to COVID 19 Exposure

Measures the impact of the COVID-19 pandemic on a family. The parent report measures consists of 25 items that assess exposure to the COVID-19 pandemic and related stressors. Each question is scores 0=No, 1=Yes. Scores range from 0-25, with higher scores representing greater COVID exposure.

Time frame
T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Urbana-Champaign

Lead sponsor

Save the Children

Collaborator

Care Connections Mental Wellness and Learning Center

Collaborator

Dickinson Independent School District

Collaborator

Bay District Schools

Collaborator

University of Houston

Collaborator

Baylor College of Medicine

Collaborator

University of South Florida

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Coalition for Compassionate Schools

Collaborator

Boys and Girls Club of Manatee County

Collaborator

Communities in Schools of Galveston County

Collaborator

Communities in Schools Palm Beach

Collaborator

Communities in Schools Gulf South

Collaborator

R'Club Child Care Inc.

Collaborator

Boys and Girls Clubs of Tampa Bay

Collaborator