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Using a Primary Care- Based Stepped-Care Model of Trauma Focused Cognitive Behavioral Therapy (PSC-TF-CBT)to Reduce Trauma Symptoms and Negative Mental Health Sequelae

ConditionTrauma Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-14
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to evaluating the feasibility of delivering a trauma-focused intervention among children with elevated traumatic stress symptoms in primary care

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

able to read or understand English

Disqualifiers

Currently receiving mental health treatment elsewhere

Evidence of active suicidality

Presence of psychotic symptoms

Score ≥ 40 on the child-report measure, or

Trial design

Design model

Single group

Treatments tested in this trial

  • PSC-TF-CBT

    Behavioral

    The intervention is a stepped-care adaptation of Trauma-Focused Cognitive Behavioral Therapy (PSC-TF-CBT) delivered within pediatric primary care. Treatment intensity is matched to each participant's individual clinical needs, with participants receiving lower-intensity intervention components initially and progressing to more intensive trauma-focused treatment as clinically indicated. PSC-TF-CBT incorporates trauma-focused cognitive behavioral therapy strategies for youth and includes caregiver involvement.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: PSC-TF-CBTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility as assessed by the number of participants recruited

Time frame
From baseline to end of study (30 weeks form baseline)
2

Feasibility as assessed by the number of participants enrolled in the study

Time frame
end of study (30 weeks form baseline)
3

Feasibility as assessed by the number of participants retained in the study

Retained is described as participants who enroll in the study and remain enrolled through the study endpoint/final.

Time frame
end of study (30 weeks form baseline)
4

Feasibility as assessed by the proportion of scheduled intervention sessions attended by each participant

Time frame
From baseline to end of study (30 weeks form baseline)

Secondary outcomes

1

Change in youth anxiety symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS)(child's self-report)

This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms

Time frame
Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
2

Change in youth anxiety symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS), (parent report )

This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms

Time frame
Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
3

Change in youth depressive symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS) (child's self-report)

This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms

Time frame
Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
4

Change in youth depressive symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS) (parent report)

This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms

Time frame
Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

The Texas Child Mental Health Care Consortium (TCMHCC)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: