Project EMPOWER-OCD
ConditionObsessive-Compulsive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University Charles River Campus
About this trial
This research study aims to adapt and evaluate the acceptability and effectiveness of Project EMPOWER-OCD for socioeconomically diverse caregivers of patients with OCD. Designed to reduce obstacles (e.g. months long time commitment, high cost, transportation) to treatment that caregivers may be particularly prone to, project EMPOWER-OCD will provide targeted intervention of accommodation - a well-established, potentially modifiable risk factor for child anxiety, OCD, and its related disorders - in a single, self-guided session via an online format.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
be a caregiver for at least one individual with OCD, defined as living in the same household and providing daily care
be 18 years old or older
the individual they are caring for have clinically significant OCD symptoms, indicated by a score a 16 or above on the self-reported Children's Yale-Brown Obsessive Compulsive Scale - Parent Report (CY-BOCS-PR)
speak, read, and write English
Disqualifiers
does not speak English
younger than 18 years old
participation in concurrent family-based CBT treatment for the patient's OCD.
Trial design
Design model
Sequential
Treatments tested in this trial
Project EMPOWER-OCD
BehavioralProject EMPOWER-OCD is a web-based intervention for caregivers that takes about 20-25 minutes to complete that reduces accommodation. The program is drawing from an empirically supported intervention, Project EMPOWER, and will be adapted for the OCD population pending stakeholder input during phase 1 and include 5 elements: (1) an introduction to the program's rationale; (2) psychoeducation around OCD-driven avoidance, along with how caregiver accommodation can inadvertently maintain these avoidance patterns; (3) information on how caregivers can better identify patterns of avoidance, validate, and encourage approach behaviors instead; (4) creation of an "action plan" to promote approach behavior and reducing avoidance; (5) a vignette exercise in which caregivers read about another case and provide possible solutions based on what they learned. Resources for finding mental health treatment for OCD are presented at the end.
Project CARE
BehavioralTo evaluate the effects of Project EMPOWER-OCD, we will compare it to an active psychoeducation-based SSI that provides general information on caregiving and caregiver mental health. The intervention includes 5 elements that mirror Project EMPOWER: (1) introduction to the rationale for the program; (2) introduce the concept of caregiving across relationships and situations; (3) present broad information on typical development processes; (4) helping caregivers identify their own role and reflect on how caregiving looks like in their life (5) vignette exercise where caregivers identify caregiving roles, prompting reflection on roles. This active comparator intentionally does not include any psychoeducational components explicitly designed to reduce accommodation of anxiety, OCD, and its related disorders.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Project EMPOWER-OCDExperimental treatment 1 intervention
Group B: Project CAREActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Family Accommodation Scale
19-item measure designed to assess the child's OCD symptoms and the extent to which a caregiver accommodates a child's OCD symptoms. Only the part two of the measure will be used to get the report of family member's responses to OCD. Items are rated from 0 (never) to 4 (every day). Total sum score ranges from 0 to 76 with higher scores indicating more frequent parental accommodation.
Time frame
Change from baseline, 2-week follow-up, 4-week follow-up2
Children's Yale-Brown Obsessive Compulsive Scale
A two-part measure with a checklist of common obsessions and compulsions as well as a 10-item part that asks participants to report on the severity of their child's OCD rated on a 0 (none) to 4 (extreme) scale. Total sum score ranges from 0 to 40 with higher scores indicating higher symptom severity.
Time frame
Change from baseline, 2-week follow-up, 4-week follow-upSecondary outcomes
1
Parental Stress Scale
An 18-item measure of caregiving stress levels, rated on a scale of 1 (strongly disagree) to a 5 (strongly agree) scale on their perceived positive and negative experience of being a caregiver
Time frame
Change from baseline, 2-week follow-up, 4-week follow-up2
Program Feedback Scale
The program feedback scale asks participants to rate 7 statements regarding acceptability and feasibility; note whether they would recommend this activity to others; and share what they liked and would change about the SSI. The 7 statements are rated from 0 (Really Disagree) to 5 (Really Agree). Total score ranges from 0 to 35, with higher scores indicating a more positive program evaluation.
Time frame
Immediately after the SSI3
Perceived pre-to-post SSI change
a 2-item measure assesses participants' perceived change in their ability to help their children manage distressing situations from pre- to post-SSI: "compared to before you completed this program, how prepared do you feel to help your child manage distressing situations?" Participants in both groups will rate this question on a 5- point scale of 1 (much less able to help) to 5 (much more able to help).
Time frame
Immediately after the SSIOther outcomes
1
Consumer Financial Protection Bureau Financial Well-Being Scale
The CFPB Financial Well-Being Scale measures financial well-being as it relates to control over finances, capacity to absorb financial shock, and having the financial freedom to enjoy life. Parents are asked to answer 10 questions on a 0 to 4 Likert scale to generate a sum score, which is converted into a standardized score. Scores range from 14 to 95 with higher scores indicating a higher level of measure financial well-being.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov