- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06391229
Examine the Feasibility and Acceptability of Project Support
A Brief Intervention to Enhance Supportive Parenting and Treatment Engagement Among Families Waiting for Trauma-Focused Services
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caitlin Rancher, PhD
- Phone Number: 843-608-0491
- Email: rancher@musc.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Family is seeking trauma-focused services for their child as measured by their placement on the waitlist for services at the National Crime Victims Center;
- Child is between 5 - 12 years old;
- Caregiver agreed to be contacted for volunteer research opportunities;
- Caregiver and child can communicate in either English or Spanish;
- Child has been living with caregiver for at the last 6 months or longer;
- Family is able to participate in services delivered via telehealth.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Project Support
All caregivers will receive the Project Support intervention over the course of 4-6 weeks.
|
Caregivers will receive up to four, 60- to 90-minute sessions focused on teaching two parenting skills - attentive listening and comforting. Attentive listening involves providing accurate and timely responses to show interest and keep the child engaged until they are ready to end the conversation. Comforting involves using the same attentive listening skills when the child is upset or distressed. Effective mastery of the listening and comforting skills also requires caregivers to withhold any non-listening or non-comforting responses (e.g., interruptions, criticisms). The program is individually tailored such that caregivers with stronger skills could complete the program in less time (i.e., fewer sessions). Service providers educate caregivers about the skills, then engage in an iterative process of modeling the skills, engaging the caregivers in behavioral practice, and providing tailored, supportive feedback to help caregivers gain mastery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Supportive Parenting assessed by the Alabama Parenting Questionnaire
Time Frame: Baseline to Post-test (6 weeks)
|
Caregivers and children will complete convergent versions of the Alabama Parenting Questionnaire.
Responses to this questionnaire assess several domains of parenting.
Responses to items assessing supportive parenting (e.g,.
"you praise your child if he/she behaves well") are made on a 5-point scale (0 = never, 1 = almost never, 2 = sometime, 3 = often, 4 = always).
Responses are summed to create a total score.
Higher scores of supportive parenting measured on the Alabama Parenting Questionnaire have previously been associated with lower levels of child behavior problems.
This outcome measure will be assessed by comparing within-person mean levels of supportive parenting from baseline to post-test.
|
Baseline to Post-test (6 weeks)
|
Parenting self-efficacy assessed by the Parenting Sense of Competence Scale
Time Frame: Baseline to Post-test (6 weeks)
|
Caregivers will complete the parenting self-efficacy subscale of the Parenting Sense of Competence Scale.
Responses to items on this questionnaire measuring self-efficacy (e.g., "If anyone can find the answer to what is troubling my child, I am the one") are made on a 6-point scale (1 = strongly disagree to 6 = strongly agree).
Responses are summed to create a total score.
Higher scores on the self-efficacy subscale have been associated with lower levels of child externalizing problems.
This outcome measure will be assessed by comparing within-person mean levels of parenting self-efficacy from baseline to post-test.
|
Baseline to Post-test (6 weeks)
|
Hopefulness assessed by the Beck Hopelessness Scale-4
Time Frame: Baseline to Post-test (6 weeks)
|
Caregivers will complete the Beck Hopelessness Scale-4.
Responses to items on this questionnaire measuring hopelessness (e.g., "I feel the future is hopeless and that things cannot improve") are made on a 4-point scale (0 = not typical, 1 = rarely typical, 2 = typical, 3 = very typical).
Responses are summed to create a total score, with higher scores indicating greater hopelessness.
The Beck Hopelessness Scale-4 has demonstrated robust internal reliability, coefficient alphas = .84-.88.
This outcome measure will be assessed by comparing within-person mean levels of hopelessness from baseline to post-test.
|
Baseline to Post-test (6 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child psychological distress assessed by the Pediatric Symptom Checklist
Time Frame: Baseline to Post-test (6 weeks)
|
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.
Scores on the Pediatric Symptom Checklist have demonstrated convergent validity with other measures of child psychological distress.
This outcome measure will be assessed by comparing within-person mean levels of child psychological distress from baseline to post-test.
|
Baseline to Post-test (6 weeks)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Caitlin Rancher, PhD, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00136524
- K99HD111677 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parent-Child Relations
-
Esteban Gómez MuzzioNot yet recruitingParent-Child Relations | Parenting | Parent-child Problem
-
The University of Hong KongCompletedParent-Child Relations | Child DevelopmentHong Kong
-
University of LiegeActive, not recruitingParent-Child Relations | Child DevelopmentBelgium
-
McGill UniversitySave the Children; European Network of Foundations Children and Violence Evaluation... and other collaboratorsUnknown
-
Government College University FaisalabadActive, not recruitingParent-Child RelationsPakistan
-
University of OttawaWithdrawnParent-Child RelationsCanada
-
National Taipei University of Nursing and Health...CompletedParent-Child Relations
-
University of CalgaryRecruitingParent-Child RelationsCanada
-
University of OttawaRecruitingParent-Child RelationsCanada
-
Universitätsklinikum Hamburg-EppendorfRecruitingParent-Child RelationsGermany
Clinical Trials on Project Support
-
Weill Medical College of Cornell UniversityNational Institute on Aging (NIA)Not yet recruitingMild Cognitive ImpairmentUnited States
-
Harvard UniversityCompletedDepression | Stress | AnxietyUnited States
-
Children's National Research InstituteChildren's Hospital ColoradoEnrolling by invitation
-
Harvard UniversityCompletedDepression | Stress | AnxietyUnited States
-
University of Maryland, College ParkAmerican Cancer Society, Inc.; Community Ministry of Prince George's County; Access...CompletedBreast Cancer | Colorectal Cancer | Prostate CancerUnited States
-
Northwestern UniversityNational Institute of Mental Health (NIMH)Active, not recruitingDepressionUnited States
-
Ostfold University CollegeOslo University Hospital; Norwegian School of Sport SciencesCompletedAthletic Injuries | Eating Disorders | Adolescent - Emotional Problem | Body Dissatisfaction | Disordered EatingNorway
-
NYU Langone HealthEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedLanguage Development DisordersUnited States
-
Cornell CollegeNational Institute of Mental Health (NIMH)Completed
-
Fenway Community HealthNational Institute of Mental Health (NIMH)CompletedHIV InfectionsUnited States