Depression Clinical Trial
Official title:
PCORI-1306-02918 Evaluation of Parent-based Programs to Support Children After Traumatic Injury
Verified date | March 2019 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Children presenting to the University of Iowa Health Care System (UIHC), Blank Children's
Hospital (Blank), Children's Hospital of Minneapolis, and Kansas City Mercy Children's
Hospital with an injury resulting in admission will be the sample population. A child will be
included if they are 10-17 years old with an unintentional injury. Consenting children and
their parents will be asked to complete a series of four questionnaires: before hospital
discharge, at 1-month post discharge, 3-months and 6-months post discharge. The parent-child
dyads will be randomized (1:1) to receive 1) training in Link for Injured Kids or 2) Trauma
Education. The survey completed in the hospital will be a paper survey or online via an iPad,
and follow-up surveys can be completed on paper or online.
Aim #1: Assess the feasibility of Link for Injured Kids through qualitative research with
parents and providers of previously injured children from UI Children's Hospital.
Aim #2: Through a randomized trial, determine the range of potential psychosocial and
behavioral health indicators possibly impacted by Link for Injured Kids. This will identify
the types of outcomes which could include post-traumatic stress disorder (PTSD), depression,
nonspecific distress, quality of life, absenteeism, school performance, coping skills,
communication skills, and access to mental health.
Status | Completed |
Enrollment | 628 |
Est. completion date | March 31, 2018 |
Est. primary completion date | March 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 17 Years |
Eligibility |
Inclusion Criteria: - unintentional injury Exclusion Criteria: - intentional injury - non-English speaking families - children with cognitive impairment. |
Country | Name | City | State |
---|---|---|---|
United States | Blank Children's Hospital | Des Moines | Iowa |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | Children's Mercy Hospital | Kansas City | Missouri |
United States | Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Marizen Ramirez | Blank Children's Hospital, Children's Hospitals and Clinics of Minnesota, Children's Mercy Hospital Kansas City, Patient-Centered Outcomes Research Institute, The University of Queensland |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-traumatic Stress Symptoms (Child Post-traumatic Stress Disorder (PTSD) Scale) Through the First and Last Survey Administered Post-Baseline | Post-traumatic stress disorder (PTSD) (modified) scale, a questionnaire. Lower scores are preferable. Scores may range from 1 to 52. Responses submitted by parents are with respect to themselves. Responses submitted by children are with respect to themselves. | surveys were provided at 6 weeks, 3 months, and 6 months post-baseline | |
Primary | Depressive Symptoms (Center for Epidemiologic Studies Depression Scale (CES-D) Through the First and Last Survey Administered Post-Baseline | Center for Epidemiologic Studies Depression Scale (CES-D) (modified), a questionnaire. Lower scores are preferable. Scores may range from 1 to 31. Responses submitted by parents are with respect to themselves. Responses submitted by children are with respect to themselves. | surveys were provided at 6 weeks, 3 months, and 6 months post-baseline | |
Primary | Quality of Life (Questionnaire) Through the First and Last Survey Administered Post-Baseline | Quality of Life, a questionnaire (modified). Lower scores are preferable. Scores may range from 1 to 101. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves. | surveys were provided at 6 weeks, 3 months, and 6 months post-baseline | |
Primary | Psychological Distress Symptoms (Kessler Screening Scale for Psychological Distress (K6)) Through the First and Last Survey Administered Post-Baseline | Psychological Distress Symptoms (Kessler Screening Scale for Psychological Distress (K6)) (modified). Lower scores are preferable. Scores may range from 1 to 25. Responses submitted by parents are with respect to themselves. Responses submitted by children are with respect to themselves. | surveys were provided at 6 weeks, 3 months, and 6 months post-baseline | |
Primary | Strengths and Difficulties (Questionnaire to Assess Internalizing and Externalizing Behaviors (SDQ)) Through the First and Last Survey Administered Post-Baseline | Strengths and Difficulties (Questionnaire to Assess Internalizing and Externalizing Behaviors (SDQ)) (modified). Lower scores are preferable. Scores may range from 1 to 41. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves. | surveys were provided at 6 weeks, 3 months, and 6 months post-baseline | |
Primary | Emotional Symptoms (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline | Emotional Symptoms (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves. | surveys were provided at 6 weeks, 3 months, and 6 months post-baseline | |
Primary | Conduct Problems (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline | Conduct Problems (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves. | surveys were provided at 6 weeks, 3 months, and 6 months post-baseline | |
Primary | Hyperactivity (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline | Hyperactivity (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves. | surveys were provided at 6 weeks, 3 months, and 6 months post-baseline | |
Primary | Peer Relationship Problems (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline | Peer Problems (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves. | surveys were provided at 6 weeks, 3 months, and 6 months post-baseline | |
Primary | Prosocial Behavior (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline | Prosocial Behavior (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves. | surveys were provided at 6 weeks, 3 months, and 6 months post-baseline | |
Primary | Implementation Through the First and Last Survey Administered Post-Baseline | Implementation was measured on a scale ranging from 0 to 2, where a score of 0 is indicative of no implementation, a score of 1 indicative of partial implementation, and 2 of full implementation. For the trauma education group, a score of 0 was assigned if the subject never read the provided materials, a score of 1 was assigned if participants read but did not use the provided materials, and a score of 2 was assigned if the participant read and used the material at least once. For the link group, a score of 0 was assigned if the subject did not use any of the skills associated with the intervention, a score of 1 was assigned if at least one but not all three skills were used, and a score of 2 was assigned if all skills were used. | surveys were provided at 6 weeks, 3 months, and 6 months post-baseline |
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