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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06391229
Enrollment
32
Registered
2024-04-30
Start date
2024-07-02
Completion date
2025-06-03
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Mental Disorder, Parent-Child Relations, Parenting

Keywords

Non-offending caregiver, Child trauma

Brief 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. 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.

Interventions

BEHAVIORALProject Support

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.

Sponsors

Medical University of South Carolina
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Supportive Parenting Assessed by the Alabama Parenting QuestionnaireBaseline 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 ScaleBaseline 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-4Baseline 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.

Secondary

MeasureTime frameDescription
Child Psychological Distress Assessed by the Pediatric Symptom ChecklistBaseline to Post-test (6 weeks)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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCaitlin Rancher, PhD

Medical University of South Carolina

Participant flow

Pre-assignment details

Protocol enrollment represents the number of total participants enrolled (caregivers and their child). The Milestones within the Participant Flow report individual children and caregivers, although they participated as dyads.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
16 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
15 Participants
Child psychological distress assessed by the Pediatric Symptom Checklist14.28 Scores on a scale
STANDARD_DEVIATION 4.67
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Hopefulness assessed by the Beck Hopelessness Scale-42.06 Scores on a scale
STANDARD_DEVIATION 2.17
Parenting self-efficacy assessed by the Parenting Sense of Competence Scale32.35 Scores on a scale
STANDARD_DEVIATION 5.21
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
Race (NIH/OMB)
White
17 Participants
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
6 Participants
Supportive Parenting assessed by the Alabama Parenting Questionnaire9.50 Scores on a scale
STANDARD_DEVIATION 2

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 160 / 16
other
Total, other adverse events
0 / 160 / 16
serious
Total, serious adverse events
0 / 160 / 16

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026