Parent-Child RelationsNCT06391229
Examine the Feasibility and Acceptability of Project Support
A study testing Project Support in people with Parent-Child Relations and Parenting, run by Medical University of South Carolina at 1 site in United States.
Trial summary
In this study, the investigators will conduct a proof-of-concept pilot trial of delivering the Project Support Positive Parenting Module (Project Support) to n = 30 families waiting for trauma-focused services. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Parent-Child Relations, Parenting, Child Mental Disorder
- What is being tested?
- Project Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2024to 3 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
National Crime Victims Center
Charleston, South Carolina, 29425
About this study
Official title: A Brief Intervention to Enhance Supportive Parenting and Treatment Engagement Among Families Waiting for Trauma-Focused Services
In this study, the investigators will conduct a proof-of-concept pilot trial of delivering the Project Support Positive Parenting Module (Project Support) to n = 30 families waiting for trauma-focused services. Investigators hypothesize that Project Support will be feasible and acceptable as evidenced by benchmarks for recruitment, retention at post assessment, engagement, fidelity, and program satisfaction. Investigators will also explore trends on caregiver emotional support, parenting self-efficacy, and child mental health symptoms.
Read the detailed description
Over two-thirds of children experience traumatic events such as child maltreatment, violence, or sudden or violent loss. Many of these children sustain significant emotional and developmental difficulties including trauma symptoms, aggression, and suicidality. Emotional support from a caregiver is theorized to buffer against the effects of trauma; however, many caregivers lack the self-efficacy and skills to effectively support their child, or struggle to apply these skills during the stressful time following trauma. Unfortunately, programs designed for caregivers following child trauma are scarce. Existing interventions are lengthy (lasting 8-20 sessions) and result in families placed on long waitlists. This proposal asserts the adverse effects of child trauma can be interrupted though a brief intervention (the Project Support Positive Parenting Module) that enhances supportive parenting - delivered via telehealth to families on waitlists for trauma-focused services. In this study, Investigators will conduct a proof-of-concept pilot trial with n = 30 families waiting for trauma-focused services. Investigators hypothesize that Project Support will be feasible and acceptable as evidenced by benchmarks for recruitment, retention at post assessment, engagement, fidelity, and program satisfaction. Investigators will also explore trends on caregiver emotional support, parenting self-efficacy, and child mental health symptoms. Long-term, this research will generate an effective intervention that addresses the needs of families affected by trauma, which can be scaled up to address other public health epidemics that impede supportive parenting and child development.
- Conditions
- Parent-Child Relations, Parenting, Child Mental Disorder
- Being tested
- Project Support
- Keywords
- Non-offending caregiver, Child trauma
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project SupportBehavioural
Also called Project Support Positive Parenting Module
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.
| Study group | Role | What they receive |
|---|---|---|
| Project Support | Experimental | All dyads (caregivers and their child) will receive the Project Support intervention over the course of 4-6 weeks. Receives: Behavioral: Project Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supportive Parenting Assessed by the Alabama Parenting Questionnaire
Supportive Parenting scale includes 3 items (e.g,. "you praise your child if he/she behaves well") made on a 5-point scale (0 = never, 1 = almost never, 2 = sometime, 3 = often, 4 = always). Scale ranges from 0 to 12. Item responses are summed. Higher scores indicate a better outcome of more supportive parenting.
Measured: Baseline to Post-test (6 weeks)
Parenting Self-efficacy Assessed by the Parenting Sense of Competence Scale
Parenting self-efficacy subscale includes 8 items (e.g., "If anyone can find the answer to what is troubling my child, I am the one") made on a 6-point scale (1 = strongly disagree to 6 = strongly agree). Scale ranges from 8 to 48. Item responses are summed. Higher scores indicate better outcome of greater parenting self-efficacy.
Measured: Baseline to Post-test (6 weeks)
Hopefulness Assessed by the Beck Hopelessness Scale-4
The Beck Hopelessness Scale-4 includes 4 items measuring hopelessness (e.g., "I feel the future is hopeless and that things cannot improve") made on a 4-point scale (0 = not typical, 1 = rarely typical, 2 = typical, 3 = very typical). Scale ranges from 0 to 12. Item responses are summed. Higher scores indicate worse outcomes in that they represent a higher degree of hopelessness.
Measured: Baseline to Post-test (6 weeks)
Secondary outcomes (1)
Child Psychological Distress Assessed by the Pediatric Symptom Checklist
The total problems scale on the Pediatric Symptom Checklist includes 17 items measuring child psychological distress (e.g., "Feels sad, unhappy") made on a 3-point scale (0 = never, 1 = sometimes, 2 = often). Scale ranges from 0 to 34. Item responses are summed. Higher scores indicate worse outcomes in that they represent higher psychological distress.
Measured: Baseline to Post-test (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start2 Jul 2024
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Caitlin Elizabeth Rancher, Medical University of South Carolina
- Investigators
- Caitlin Rancher, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391229
- Sponsor's protocol ID
- Pro00136524
- Other IDs
- K99HD111677
- Status last verified
- Jun 2025
- First submitted
- 22 Apr 2024
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Intervention to Enhance Supportive Parenting and Treatment Engagement Among Families Waiting for Trauma-Focused Services
- ClinicalTrials.gov ID
- NCT06391229
- Acronym / sponsor ID
- Pro00136524
- Conditions
- Parent-Child Relations, Parenting, Child Mental Disorder
- Keywords
- Non-offending caregiver, Child trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Posted 15 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators will conduct a proof-of-concept pilot trial of delivering the Project Support Positive Parenting Module (Project Support) to n = 30 families waiting for trauma-focused services. Investigators hypothesize that Project Support will be feasible and acceptable as evidenced by benchmarks for recruitment, retention at post assessment, engagement, fidelity, and program satisfaction. Investigators will also explore trends on caregiver emotional support, parenting self-efficacy, and child mental health symptoms.
Detailed description
Over two-thirds of children experience traumatic events such as child maltreatment, violence, or sudden or violent loss. Many of these children sustain significant emotional and developmental difficulties including trauma symptoms, aggression, and suicidality. Emotional support from a caregiver is theorized to buffer against the effects of trauma; however, many caregivers lack the self-efficacy and skills to effectively support their child, or struggle to apply these skills during the stressful time following trauma. Unfortunately, programs designed for caregivers following child trauma are scarce. Existing interventions are lengthy (lasting 8-20 sessions) and result in families placed on long waitlists. This proposal asserts the adverse effects of child trauma can be interrupted though a brief intervention (the Project Support Positive Parenting Module) that enhances supportive parenting - delivered via telehealth to families on waitlists for trauma-focused services. In this study, Investigators will conduct a proof-of-concept pilot trial with n = 30 families waiting for trauma-focused services. Investigators hypothesize that Project Support will be feasible and acceptable as evidenced by benchmarks for recruitment, retention at post assessment, engagement, fidelity, and program satisfaction. Investigators will also explore trends on caregiver emotional support, parenting self-efficacy, and child mental health symptoms. Long-term, this research will generate an effective intervention that addresses the needs of families affected by trauma, which can be scaled up to address other public health epidemics that impede supportive parenting and child development.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Project Support | Experimental | Behavioral: Project SupportAll dyads (caregivers and their child) will receive the Project Support intervention over the course of 4-6 weeks. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project SupportAlso: Project Support Positive Parenting ModuleCaregivers 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. | Behavioural | Project Support |
Primary outcome
Supportive Parenting Assessed by the Alabama Parenting Questionnaire
Time frame: Baseline to Post-test (6 weeks)
Supportive Parenting scale includes 3 items (e.g,. "you praise your child if he/she behaves well") made on a 5-point scale (0 = never, 1 = almost never, 2 = sometime, 3 = often, 4 = always). Scale ranges from 0 to 12. Item responses are summed. Higher scores indicate a better outcome of more supportive parenting.
Parenting Self-efficacy Assessed by the Parenting Sense of Competence Scale
Time frame: Baseline to Post-test (6 weeks)
Parenting self-efficacy subscale includes 8 items (e.g., "If anyone can find the answer to what is troubling my child, I am the one") made on a 6-point scale (1 = strongly disagree to 6 = strongly agree). Scale ranges from 8 to 48. Item responses are summed. Higher scores indicate better outcome of greater parenting self-efficacy.
Hopefulness Assessed by the Beck Hopelessness Scale-4
Time frame: Baseline to Post-test (6 weeks)
The Beck Hopelessness Scale-4 includes 4 items measuring hopelessness (e.g., "I feel the future is hopeless and that things cannot improve") made on a 4-point scale (0 = not typical, 1 = rarely typical, 2 = typical, 3 = very typical). Scale ranges from 0 to 12. Item responses are summed. Higher scores indicate worse outcomes in that they represent a higher degree of hopelessness.
1 secondary outcome
Child Psychological Distress Assessed by the Pediatric Symptom Checklist
Time frame: Baseline to Post-test (6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caitlin Rancher, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Support in people with Parent-Child Relations and Parenting, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supportive Parenting Assessed by the Alabama Parenting Questionnaire (time frame: Baseline to Post-test (6 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.