Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
800 participants
INTERVENTIONAL
2023-06-28
2025-12-29
Brief Summary
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* Which telehealth support programs best meet the needs of rare disorder caregivers?
* How can individuals be matched to support programs that are right for them? What aspects of an individual (e.g., demographics, mental health symptoms, family characteristics, lifestyle) predict whether treatment will be a good fit?
* Does peer-to-peer coaching help improve patients' experiences during telehealth treatment?
Participants will be asked to complete a 12-week treatment program, which may include self-guided resources, individual therapies, group therapies, and/or peer-to-peer coaching.
Before, during, and after treatment, participants will complete questionnaires to help researchers understand their experiences, symptoms, and impressions of their support program. Questionnaires will include both standard forms (administered up to 5 times throughout the study) and brief "snapshot surveys" that participants complete on their smartphones up to 3 times per day.
Some participants will be assigned to a waitlist control, which means that they will provide data while they are not yet completing a support program. These participants will be assigned to a support program in the next treatment phase.
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Detailed Description
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AIM 1: Develop and optimize a personalized health algorithm to match neurogenetic syndrome (NGC) caregivers to digital health treatments using a combination of standard clinical tools and smartphone-based EMA data.
Extant clinical and EMA data on NGC caregiver response to COVID-19 was used to develop an initial routing algorithm to match families to treatment type and intensity. This aim will compare the effectiveness of algorithm-assigned treatment to "treatment as usual," optimizing the algorithm across four waves of intervention. Interventions will be brief, evidence-based, digital health treatments administered by highly supervised clinical trainees, a cost-efficient model for directly targeting the secondary health effects of COVID-19.
AIM 2: Test the efficacy of peer-to-peer coaching, deployed by trained NGC caregivers using an evidence-based motivational interviewing protocol, in enhancing treatment uptake and clinical outcomes.
Peer coaches who are also NGC caregivers will be trained to deploy evidence-based Participation Enhancement Interventions designed to support treatment engagement and reduce potential barriers. This aim will evaluate the feasibility and effectiveness of this approach in reducing secondary health effects of COVID-19 by comparing outcomes across participants who were randomized to complete treatment with and without peer coaches. Peer coaches will also provide valuable stakeholder input for designing and optimizing the digital treatment network.
DETAILED HUMAN SUBJECTS PROCEDURE:
ENROLLMENT AND CONSENT 1. At the entry of the study, caregivers will be assessed by the study team to determine eligibility. The caregivers will then consent to baseline collection. A subset of caregivers will be enrolled at this phase as waitlist controls. Waitlist controls will complete the same data collection described below, but without any support program.
BASELINE. The baseline period of the study lasts two weeks. During this time, caregivers will complete initial study forms and "snapshot surveys," which are brief questionnaires sent three times per day via their smartphones.
ROUTING. After baseline data collection is complete, caregivers will be routed to a support program. Random number generators will be used to route caregivers to their study arm, described below.
Caregivers may opt out of broadly completing either child-focused or self-focused treatments but may not select their specific treatment modality. As an exception, any Black caregiver in the study is eligible to add the CICBT group to their assigned support program.
CONSENT 2 and INTERVENTION. Participants will provide informed consent specific to their assigned intervention then begin their 12-week support program. Programs are described below. During intervention, caregivers will be asked to complete study forms to assess how their characteristics and experiences have changed interventions; forms will be collected at start of treatment, midpoint, and endpoint. Caregivers will also complete "snapshot surveys" (3x/day) during this time.
FOLLOW UP. Two weeks after completing treatment, caregivers will complete follow-up forms and a 2-week period of "snapshot surveys."
ADDITIONAL PROCEDURES:
This study will occur across four phases. Phases I and II will enroll up to 500 participants (to yield 400 participants total) who will be randomly assigned to Algorithm (Algorithm 1 versus No Algorithm) and Peer Coaching (Peer Coaching versus No Peer Coaching).
After Phase II, investigators will convene a "think tank" that will evaluate primary and secondary endpoints across arms, with the goal of determining how to optimize the algorithm. Data analyses will be performed by staff who are not involved in clinical operations. Peer coaches (who are rare disorder caregivers), clinicians, biostatisticians, and scientists will collaboratively participate in this think tank, with the goal to optimize the algorithm prior to Phase III.
Phase III will enroll up to 250 participants (to yield 200) who will receive the optimized Algorithm 2 and be randomly assigned to Peer Coaching conditions. After Phase III, a second think tank will be convened to optimize Algorithm 3.
Phase IV will enroll up to 250 participants (to yield 200) who will receive the optimized Algorithm 3 and will be randomly assigned to Peer Coaching conditions.
Final analyses will compare Algorithm 3 to Algorithm 2, Algorithm 1, and Waitlist Controls.
RIGOR AND REPRODUCIBILITY.
Algorithms will be uploaded to a secure, locked site prior to each round of study assignment. Analyses will be preregistered, and all code will be available for replication efforts. Masking procedures are described elsewhere in this document.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
Across Waves I-IV, caregivers are randomly assigned to receive peer coaching ("Peer Coaching") or to receive check-ins by a staff member unfamiliar with the peer coaching protocol ("No Peer Coaching").
Across Waves I-III, a subset of caregivers are assigned to a waitlist control that does not include any treatment or peer coaching.
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
No Algorithm + Participation Enhancement Intervention
Participants are randomly assigned to support program without use of a personalized health algorithm AND receive the participation enhancement intervention.
Acceptance and Commitment Therapy (ACT)
ACT will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual
CICBT-Individual will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Group
CICBT-Group will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Dialectical Behavioral Therapy (DBT)
DBT will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Durand Sleep Intervention
Durand Sleep Intervention will be deployed weekly for 12 weeks, alternating between individual and group formats, via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist or behavioral analyst.
RUBI Intervention
RUBI will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Naturalistic Communication Intervention (NCI)
NCI will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Self-Guided Resources
Participants will be provided a self-guided resource notebook that includes 12 weeks of content that parallels the topics examined in other support programs (child behavior management, child sleep, child communication, caregiver mental health, caregiver health behaviors, community connection)
Participation Enhancement Intervention (PEI)
A standardized PEI intervention will be conducted by trained peer coaches who are also rare disorder caregivers. Each peer coach will work with their clients to complete a "Change Plan Worksheet" and will complete two booster sessions at midpoint and end of treatment. Coaches will also meet with their clients after follow-up data are complete to support connection back to community resources and patient-specific rare disorder communities.
No Algorithm + No Participation Enhancement Intervention
Participants are randomly assigned to support program without use of a personalized health algorithm AND do not receive the participation enhancement intervention.
Acceptance and Commitment Therapy (ACT)
ACT will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual
CICBT-Individual will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Group
CICBT-Group will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Dialectical Behavioral Therapy (DBT)
DBT will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Durand Sleep Intervention
Durand Sleep Intervention will be deployed weekly for 12 weeks, alternating between individual and group formats, via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist or behavioral analyst.
RUBI Intervention
RUBI will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Naturalistic Communication Intervention (NCI)
NCI will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Self-Guided Resources
Participants will be provided a self-guided resource notebook that includes 12 weeks of content that parallels the topics examined in other support programs (child behavior management, child sleep, child communication, caregiver mental health, caregiver health behaviors, community connection)
Algorithm 1 + Participation Enhancement Intervention
Participants are assigned to support programs using Algorithm 1 AND receive the participation enhancement intervention.
Acceptance and Commitment Therapy (ACT)
ACT will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual
CICBT-Individual will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Group
CICBT-Group will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Dialectical Behavioral Therapy (DBT)
DBT will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Durand Sleep Intervention
Durand Sleep Intervention will be deployed weekly for 12 weeks, alternating between individual and group formats, via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist or behavioral analyst.
RUBI Intervention
RUBI will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Naturalistic Communication Intervention (NCI)
NCI will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Self-Guided Resources
Participants will be provided a self-guided resource notebook that includes 12 weeks of content that parallels the topics examined in other support programs (child behavior management, child sleep, child communication, caregiver mental health, caregiver health behaviors, community connection)
Participation Enhancement Intervention (PEI)
A standardized PEI intervention will be conducted by trained peer coaches who are also rare disorder caregivers. Each peer coach will work with their clients to complete a "Change Plan Worksheet" and will complete two booster sessions at midpoint and end of treatment. Coaches will also meet with their clients after follow-up data are complete to support connection back to community resources and patient-specific rare disorder communities.
Algorithm 1 + No Participation Enhancement Intervention
Participants are assigned to support programs using Algorithm 1 AND do not receive the participation enhancement intervention.
Acceptance and Commitment Therapy (ACT)
ACT will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual
CICBT-Individual will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Group
CICBT-Group will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Dialectical Behavioral Therapy (DBT)
DBT will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Durand Sleep Intervention
Durand Sleep Intervention will be deployed weekly for 12 weeks, alternating between individual and group formats, via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist or behavioral analyst.
RUBI Intervention
RUBI will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Naturalistic Communication Intervention (NCI)
NCI will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Self-Guided Resources
Participants will be provided a self-guided resource notebook that includes 12 weeks of content that parallels the topics examined in other support programs (child behavior management, child sleep, child communication, caregiver mental health, caregiver health behaviors, community connection)
Algorithm 2 + Participation Enhancement Intervention
Participants are assigned to support programs using Algorithm 2 AND receive the participation enhancement intervention.
Acceptance and Commitment Therapy (ACT)
ACT will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual
CICBT-Individual will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Group
CICBT-Group will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Dialectical Behavioral Therapy (DBT)
DBT will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Durand Sleep Intervention
Durand Sleep Intervention will be deployed weekly for 12 weeks, alternating between individual and group formats, via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist or behavioral analyst.
RUBI Intervention
RUBI will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Naturalistic Communication Intervention (NCI)
NCI will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Self-Guided Resources
Participants will be provided a self-guided resource notebook that includes 12 weeks of content that parallels the topics examined in other support programs (child behavior management, child sleep, child communication, caregiver mental health, caregiver health behaviors, community connection)
Participation Enhancement Intervention (PEI)
A standardized PEI intervention will be conducted by trained peer coaches who are also rare disorder caregivers. Each peer coach will work with their clients to complete a "Change Plan Worksheet" and will complete two booster sessions at midpoint and end of treatment. Coaches will also meet with their clients after follow-up data are complete to support connection back to community resources and patient-specific rare disorder communities.
Algorithm 2 + No Participation Enhancement Intervention
Participants are assigned to support programs using Algorithm 2 AND do not receive the participation enhancement intervention.
Acceptance and Commitment Therapy (ACT)
ACT will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual
CICBT-Individual will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Group
CICBT-Group will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Dialectical Behavioral Therapy (DBT)
DBT will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Durand Sleep Intervention
Durand Sleep Intervention will be deployed weekly for 12 weeks, alternating between individual and group formats, via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist or behavioral analyst.
RUBI Intervention
RUBI will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Naturalistic Communication Intervention (NCI)
NCI will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Self-Guided Resources
Participants will be provided a self-guided resource notebook that includes 12 weeks of content that parallels the topics examined in other support programs (child behavior management, child sleep, child communication, caregiver mental health, caregiver health behaviors, community connection)
Algorithm 3 + Participation Enhancement Intervention
Participants are assigned to support programs using Algorithm 3 AND receive the participation enhancement intervention.
Acceptance and Commitment Therapy (ACT)
ACT will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual
CICBT-Individual will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Group
CICBT-Group will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Dialectical Behavioral Therapy (DBT)
DBT will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Durand Sleep Intervention
Durand Sleep Intervention will be deployed weekly for 12 weeks, alternating between individual and group formats, via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist or behavioral analyst.
RUBI Intervention
RUBI will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Naturalistic Communication Intervention (NCI)
NCI will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Self-Guided Resources
Participants will be provided a self-guided resource notebook that includes 12 weeks of content that parallels the topics examined in other support programs (child behavior management, child sleep, child communication, caregiver mental health, caregiver health behaviors, community connection)
Participation Enhancement Intervention (PEI)
A standardized PEI intervention will be conducted by trained peer coaches who are also rare disorder caregivers. Each peer coach will work with their clients to complete a "Change Plan Worksheet" and will complete two booster sessions at midpoint and end of treatment. Coaches will also meet with their clients after follow-up data are complete to support connection back to community resources and patient-specific rare disorder communities.
Algorithm 3 + No Participation Enhancement Intervention
Participants are assigned to support programs using Algorithm 3 AND do not receive the participation enhancement intervention.
Acceptance and Commitment Therapy (ACT)
ACT will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual
CICBT-Individual will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Group
CICBT-Group will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Dialectical Behavioral Therapy (DBT)
DBT will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Durand Sleep Intervention
Durand Sleep Intervention will be deployed weekly for 12 weeks, alternating between individual and group formats, via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist or behavioral analyst.
RUBI Intervention
RUBI will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Naturalistic Communication Intervention (NCI)
NCI will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Self-Guided Resources
Participants will be provided a self-guided resource notebook that includes 12 weeks of content that parallels the topics examined in other support programs (child behavior management, child sleep, child communication, caregiver mental health, caregiver health behaviors, community connection)
Waitlist Control
Participants are enrolled in the waitlist control condition, which includes identical data collection procedures to participants enrolled in support programs. Waitlist controls are offered the opportunity to enroll in future cycles.
No interventions assigned to this group
Interventions
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Acceptance and Commitment Therapy (ACT)
ACT will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual
CICBT-Individual will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Culturally Informed Cognitive Behavioral Therapy (CICBT), Group
CICBT-Group will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Dialectical Behavioral Therapy (DBT)
DBT will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist.
Durand Sleep Intervention
Durand Sleep Intervention will be deployed weekly for 12 weeks, alternating between individual and group formats, via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed psychologist or behavioral analyst.
RUBI Intervention
RUBI will be deployed weekly for 12 weeks in small groups via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Naturalistic Communication Intervention (NCI)
NCI will be deployed weekly for 12 weeks on an individual basis via secure Zoom. Treatments will be deployed by supervised graduate student clinicians under the supervision of a licensed behavioral analyst.
Self-Guided Resources
Participants will be provided a self-guided resource notebook that includes 12 weeks of content that parallels the topics examined in other support programs (child behavior management, child sleep, child communication, caregiver mental health, caregiver health behaviors, community connection)
Participation Enhancement Intervention (PEI)
A standardized PEI intervention will be conducted by trained peer coaches who are also rare disorder caregivers. Each peer coach will work with their clients to complete a "Change Plan Worksheet" and will complete two booster sessions at midpoint and end of treatment. Coaches will also meet with their clients after follow-up data are complete to support connection back to community resources and patient-specific rare disorder communities.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Child's syndrome must (1) have an established genetic cause, (2) affect the brain, resulting in moderate to severe intellectual disability in the majority of patients
* Reside in US
* Fluent in English (spoken and written)
* Seeking support for caregiver mental health/well-being and/or caregiving needs
Exclusion Criteria
* Actively in treatment that would be redundant with those offered in the protocol
* Child's syndrome is not commonly associated with (1) life expectancy less than 35 years or (2) deterioration of previously gained skills.
18 Years
70 Years
ALL
Yes
Sponsors
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University of Virginia
OTHER
University of Oregon
OTHER
University of Canterbury
OTHER
University of Missouri-Columbia
OTHER
Indiana University
OTHER
Georgia State University
OTHER
Purdue University
OTHER
Responsible Party
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KelleherLab
Associate Professor
Principal Investigators
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Bridgette Kelleher, PhD
Role: PRINCIPAL_INVESTIGATOR
Purdue University
Locations
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Purdue University
West Lafayette, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Kelleher BL. CASCADE: a community-engaged action model for generating rapid, patient-engaged decisions in clinical research. BMC Med Res Methodol. 2025 Jul 1;25(1):168. doi: 10.1186/s12874-025-02565-7.
Kelleher B, Emerson K, Graham LN, Vozka V, Wheeler A, Fadel W, Foti D, Metzger I, Rispoli M, Machalicek W, McLay L, Lane S, Neo WS, Carter A, Brown L, Brown J, McIntyre LL, Salwitz E, Dietz G, Naughton R, Peek K, Hollins N, Woodford E. Optimizing a Personalized Health Approach for Virtually Treating High-Risk Caregivers of Children With Neurogenetic Conditions (Project WellCAST): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 25;14:e64360. doi: 10.2196/64360.
Kelleher BL. CASCADE: A Community-Engaged Action Model for Generating Rapid, Patient-Engaged Decisions in Clinical Research. Res Sq [Preprint]. 2024 Aug 27:rs.3.rs-4790564. doi: 10.21203/rs.3.rs-4790564/v1.
Other Identifiers
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