Clinical trial NCT04277715: Parent Training for Youth With Chronic Symptoms
Official title: Development of a Parent Training Intervention for Pediatric Patients With Medically Unexplained Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medically Unexplained Symptoms
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: The Wallace Foundation
First posted: 2020-02-20
Enrollment: 16
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of a parent-only, group-based intervention intended to treat youth with chronic, unexplained medical symptoms such as (but not limited to) chronic fatigue, musculoskeletal pain, headache, and abdominal pain. Prior to and following the intervention, the child and parent(s) will be asked to complete several questionnaires about their well-being and functioning. The investigators predict that participation in this intervention will lead to change in relevant outcomes, including youth symptoms and functional impairment, and parenting stress and accommodation of symptoms. The investigators also predict that this group will be acceptable and feasible for parents.


Eligibility criteria: Inclusion Criteria:

* Presence of medically unexplained symptoms, including: fibromyalgia, chronic fatigue, chronic Lyme disease, irritable bowel syndrome, musculoskeletal pain, headache, abdominal pain and related bowel dysfunction, perceived cognitive impairment, or other nonspecific symptoms
* Symptoms must have been present for at least 3 months, associated with some degree of impairment (e.g., missing school), and not attributable to a known organic or medical disorder despite adequate evaluation
* Participants must be proficient or fluent in English
* Children must live with their participating parent(s) at least 50% of the time

Exclusion Criteria:

* Presence of a serious medical condition by history, including chronic autoimmune or inflammatory condition
* Lifetime history of a psychotic disorder, bipolar disorder, Autism, or intellectual disability (Note: this criterion applies to child and parent(s))
* Presence of severe emotional or behavioral problems that require a more immediate treatment

Primary outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1996)
timeFrame: Post-treatment (6-8 weeks)
Secondary outcomes:
measure: Functional Disability Inventory (FDI; Kashikar-Zuck et al., 2011)
timeFrame: Pre-treatment; Post-treatment; 3-month follow-up
measure: Pediatric Quality of Life Inventory (PedsQL; Varni, Seid, & Kurtin, 2001)
timeFrame: Pre-treatment; Post-treatment; 3-month follow-up
measure: The Symptom Impact Questionnaire-Revised (SIQR; Bennett, Friend, Jones, Ward, Han, & Ross, 2009)
timeFrame: Pre-treatment; Post-treatment; 3-month follow-up
measure: Clinical Global Impression Scale (CGI; National Institutes of Mental Health, 1985)
timeFrame: Pre-treatment; Post-treatment
measure: Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher, Khetarpal, Brent, Cully, Balach, Kaufman, & Neer, 1997)
timeFrame: Pre-treatment; Post-treatment; 3-month follow-up
measure: Children's Depression Inventory (CDI-2; Kovacs, 2011).
timeFrame: Pre-treatment; Post-treatment; 3-month follow-up
measure: Family Accommodation Scale - Anxiety (FASA; Lebowitz et al., 2013; Lebowitz, Marin, & Silverman, 2019)
timeFrame: Pre-treatment; Post-treatment; 3-month follow-up
measure: Parenting Stress Index, 4th Edition, Short-Form (PSI-4-SF; Abidin, 2012)
timeFrame: Pre-treatment; Post-treatment; 3-month follow-up
measure: The Client Credibility Questionnaire (CCQ; Borkovec & Nau, 1972)
timeFrame: Following 1st group session (1 week)
measure: Inventory of Parent Accommodations of Children's Symptoms (IPACS; Harrison, Peterson, Short, & Wetterneck, 2016)
timeFrame: Pre-treatment; Post-treatment; 3-month follow-up
measure: Child's Report of Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1988)
timeFrame: Pre-treatment; Post-treatment; 3-month follow-up
measure: Perceived Stress Scale (PSS: Cohen, Kamarck, Mermelstein, 1983)
timeFrame: Pre-treatment; Post-treatment; 3-month follow-up
measure: Child Anxiety Sensitivity Index (CASI; Silverman, Fleisig, Rabian, & Peterson, 1991)
timeFrame: Pre-treatment; Post-treatment; 3-month follow-up
measure: Affective Reactivity Index-Child and Parent versions (ARI-C/P; Stringaris, Goodman, Ferdinando, Razdan, Muhrer, Leibenluft, & Brotman, 2012)
timeFrame: Pre-treatment; Post-treatment; 3-month follow-up
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center, Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Wendy Silverman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: