Examining Whether Project Support Works
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-13
SponsorMedical University of South Carolina
About this trial
This study will involve a randomized, controlled trial with two parallel groups, Project Support and a treatment as usual control group. Families with a child on the waitlist for trauma-focused services will be invited to participate. Participation involves completing a baseline assessment of family functioning and trauma characteristics. Participants will then be randomized to either Project Support or the treatment as usual control group. All participants will be invited to complete the post-test assessment 4-6 weeks after the baseline assessment, prior to beginning trauma-focused services.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Family is seeking trauma-focused services for their child;
Child is between 6 - 13 years old;
Caregiver agreed to be contacted for volunteer research opportunities;
Caregiver and child can communicate in English or Spanish;
Disqualifiers
Child or caregiver has a diagnosis that would impair their ability to participate in or benefit from services (e.g., traumatic brain injury, developmental disability, psychosis);
Child is in Foster Care or Department of Social Services custody;
The caregiver is unwilling or unable to give informed consent and/or the child is unwilling and unable to give assent.
Trial design
Design model
Parallel
Treatments tested in this trial
Project Support
BehavioralThe Project Support intervention involves up to four 60-minute individual counseling sessions focused on teaching caregivers how to listen to and comfort their child. Participants will receive didactic instruction and feedback on their use of the skills in role-plays with a treatment provider and with their child. In the role-plays the provider first demonstrates how to use the skill in a brief example of typical situations in which the skill could be used. In these examples the caregiver takes on the role of their child and the provider takes on the role of the caregiver. Subsequently the caregiver and provider switch roles so the caregiver has an opportunity to practice executing the skill. The provider helps the caregiver process their experience of each role-play and provides real-time, targeted feedback to help the caregiver develop their ability to use the skills.
Case Management Services
BehavioralCase management services, or treatment as usual, may involve referrals for financial resources or donated goods, as well as assistance with court, law enforcement, or information about orders of protection. The nature of these services depends on the needs identified by the family and case manager. There is currently no standard "treatment" offered to families on the waitlist. This condition will receive individually tailored services, as needed.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Project SupportExperimental treatment 2 interventions
Group B: Treatment as usualOther 1 intervention
Trial outcomes
Primary outcomes
1
Parenting self-efficacy assessed by the Tool to Measure Parenting Self-Efficacy (TOPSE)
Caregivers will complete the Tool to Measure Parenting Self-Efficacy (TOPSE). Responses to this questionnaire assess several domains of parenting. Responses to items assessing parenting self-efficacy (e.g., "I am able to comfort my child") are made on a 11-point scale (0 = completely disagree, 10 = completely agree). Responses are summed to create a total score. This outcome measure will be assessed by comparing both within- and between-person changes in parenting self-efficacy from baseline to post-test.
Time frame
Baseline to Post-test (6 weeks)2
Supportive parenting assessed by the Parent Behavior Inventory
Caregivers and children will complete convergent versions of the Parent Behavior Inventory. Responses to this questionnaire assess several domains of parenting. Responses to items assessing supportive/engaged parenting (e.g., "I listen to \_\_\_'s feelings and try to understand them") are made on a 6-point scale (0 = not at all true to 5 = very true). Responses are summed to create a total score. This outcome measure will be assessed by comparing within- and between-person changes in supportive parenting from baseline to post-test.
Time frame
Baseline to Post-test (6 weeks)3
Attendance to trauma-focused treatment intake session coded from clinical records
Research staff will review clinical records to determine whether participants attended their intake session. This will be coded dichotomously as whether or not the family attends the intake appointment ( 0 = did not attend intake, 1 = attended intake). Families will be determined to have attended their intake if this is noted either in clinic records as "in treatment" or if there is an "intake note" available in the clinical record. We will monitor the status of intake attendance for up to 4 months after the family completes participation in the post-test assessment.
Time frame
4 months after Post-testSecondary outcomes
1
Child psychological distress assessed by the Pediatric Symptom Checklist
Caregivers and children will complete convergent versions of the Pediatric Symptom Checklist. Responses to items on this questionnaire measuring child psychological distress (e.g., "Feels sad, unhappy") are made on a 3-point scale (0 = never, 1 = sometimes, 2 = often). Responses are summed to create a total score, with higher scores indicating greater psychological distress. This outcome measure will be assessed by comparing within and between-person changes in child psychological distress from baseline to post-test.
Time frame
Baseline to Post-test (6 weeks)2
Child self-blame appraisals assessed by the Child Attributions and Perceptions Scale (CAPS)
Children will complete the Child Attributions and Perceptions Scale (CAPS) assessing their self-blame appraisals (e.g., "Do you blame yourself when things go wrong?") on a 5-point scale (1 = never to 5 = always). Responses are summed to create a total score, with higher scores indicating greater self-blame. This outcome measure will be assessed by comparing within- and between-person change from baseline to post-test.
Time frame
Baseline to Post-test (6 weeks)Sponsors and contacts
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Medical University of South Carolina
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov