An interventional study of Parent training in Medically Unexplained Symptoms, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
71 studies on the registry are indexed under Medically Unexplained Symptoms; 22 are open to participants now.
This study's enrollment of 16 is below the median of 68 across 53 interventional studies indexed under Medically Unexplained Symptoms.
Browse Medically Unexplained Symptoms studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Parents of participating children with chronic symptoms will receive the intervention in a virtual group format. Groups will last 90-minutes and run for 6-8 weeks. Groups will be co-led by a clinical psychologist and pediatric physician with expertise in child behavioral interventions and medically unexplained symptoms.
Behavioral: Parent training
Parents will learn evidence-based techniques for increasing support and decreasing accommodation of children's chronic symptoms.
Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1996)
The CSQ-8 is an 8-item self-report questionnaire that assesses satisfaction with (i.e., acceptability of) services received. Questions are rated on a response scale of 1("Quite dissatisfied") to 4("very satisfied"). An overall score is calculated by summing the respondent's score for each scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction with/acceptability of treatment.
Time frame: Post-treatment (6-8 weeks)
Functional Disability Inventory (FDI; Kashikar-Zuck et al., 2011)
The FDI is a 15-item rating scale that assesses functional disability (i.e., physical and psycho-social functional impairment) in children and adolescents with chronic pain and related conditions. The FDI has a parent form and a child/adolescent form. Items are rated on a scale of 0 ("No trouble") to 4 ("Impossible"). Total scores range from 0-60, with higher scores indicating greater functional disability, categorized as No/Minimal (0-12), Moderate (13-29), and Severe (30) Disability.
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Pediatric Quality of Life Inventory (PedsQL; Varni, Seid, & Kurtin, 2001)
The PedsQL is a modular, youth- and parent-report questionnaire assessing health-related quality of life in children and adolescents ages 2 to 18. The PedsQL Generic Core Scales contain 23-items about quality of life in physical, emotional, social, and school domains. Response options are on a five-point scale, ranging from 0 ("never") to 4 ("almost always"). Items are summed and higher scores indicate higher well-being.
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
The Symptom Impact Questionnaire-Revised (SIQR; Bennett, Friend, Jones, Ward, Han, & Ross, 2009)
The SIQR is used to measure physical function, overall impact of the syndrome, and symptom severity in youth (self- and parent-report). Respondents are asked to rate items on scales such as "no difficulty" to "very difficult" (physical function), "never" to "always" (impact of the syndrome), or "no pain" to "unbearable pain" (example of symptom severity). Total scores range from 0 (indicating no symptom impact) to 100 (extreme symptom impact). A 14% change in scores has been empirically determined to represent minimal clinically significant difference following treatment.
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Clinical Global Impression Scale (CGI; National Institutes of Mental Health, 1985)
The CGI is a clinician-rated measure that assesses overall severity (CGI-S) and improvement (CGI-I) of child symptoms following treatment. CGI-S scores range from 1 ("normal, not at all ill") to 7 ("extremely ill"). CGI-I scores of 1 ("very much improved") or 2 ("much improved") indicate a positive treatment response; all other responses (3 "minimally improved" to 7 "very much worse") are considered negative responses to treatment.
Time frame: Pre-treatment; Post-treatment
Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher, Khetarpal, Brent, Cully, Balach, Kaufman, & Neer, 1997)
The SCARED is a 41-item self- and parent-report questionnaire assessing a range of anxiety symptoms. It is appropriate for children and adolescents ages 8-18. Items are rated on a 3-point scale ranging from 0 ("not true or hardly ever true") to 2 ("very true or often true"). Items are summed and total scores above 25 indicate the likely presence of an anxiety disorder.
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Children's Depression Inventory (CDI-2; Kovacs, 2011).
The CDI-2 is a 28-item questionnaire assessing depressive symptoms. There are child- and parent- report versions. Respondents are asked to rate symptoms they have experienced (or observed, for parents) over the past two weeks. Each item contains 3 statements scored in order of increasing severity from 0 to 2. Higher total scores indicate greater depressive symptoms.
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Family Accommodation Scale - Anxiety (FASA; Lebowitz et al., 2013; Lebowitz, Marin, & Silverman, 2019)
The FASA is a 13-item parent- and child-report scale that assesses family accommodation of a child's anxiety symptoms. The FASA asks respondents to rate the frequency of parental accommodation, the participation of parents in child's symptoms, and the changes that parents make in routines and schedules due to child's somatic symptoms. Items are rated on a 5-point response scale. Together, these items generate the total accommodation score, with higher scores indicating greater frequency and intensity of accommodation. One additional item assesses the degree of distress the accommodation causes the parents/child, and 4 additional items assess the short-term, negative consequences of not accommodating.
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Parenting Stress Index, 4th Edition, Short-Form (PSI-4-SF; Abidin, 2012)
The PSI-4-SF is a 36-item parent-report scale that assesses three domains of parenting stress, including Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child, which combine to form a Total Stress scale. Items are rated on a 5-point scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating more parenting stress.
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
The Client Credibility Questionnaire (CCQ; Borkovec & Nau, 1972)
The CCQ will be used to assess parent expectancies about treatment. To do so, it will be administered to all parents at the end of the first intervention session, after the treatment rationale has been presented. Parents will be asked to make ratings using a scale of 0 to 2 (None, Some, A lot) about: (1) how logical the treatment seems; (2) how confident they are the treatment will be successful, and (3) how confident they would be in recommending the treatment to a friend.
Time frame: Following 1st group session (1 week)
Inventory of Parent Accommodations of Children's Symptoms (IPACS; Harrison, Peterson, Short, & Wetterneck, 2016)
The ICPACS is a 12-item parent-report measure that assesses the frequency of family accommodation of the child's pain in the past week. Items are rated on a scale ranging from 1 to 5. It includes three subscales: Modifications, Assistance, and Supportive Behaviors. An initial validation study indicated high internal consistency for the total scale (Harrison et al., 2016).
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Child's Report of Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1988)
The CRPBI is a 30-item scale used to assess current level of perceived parental behaviors, including acceptance and psychological control. Items are rated on a scale from 1 (Not like...) to 3 (A lot like ... my mother). A higher score indicates higher perceived behaviors. There is also a parent-report version of this scale (PRPBI).
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Perceived Stress Scale (PSS: Cohen, Kamarck, Mermelstein, 1983)
The PSS is a 14-item scale that assesses perceived stress of life situations in adolescents and adults. Items are scored on a 5-point scale (0=never to 4=very often). Higher total scores indicate greater levels of perceived stress. The PSS has satisfactory reliability and has well-established validity in relation to physiological stress responses and anxiety and depressive disorders.
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Child Anxiety Sensitivity Index (CASI; Silverman, Fleisig, Rabian, & Peterson, 1991)
The CASI is an 18-item child self-report measure that assesses the extent to which children interpret anxiety symptoms as having negative physical, mental and social consequences. The scale has good construct validity, internal consistency and test-retest reliability (Silverman et al., 1991).
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Affective Reactivity Index-Child and Parent versions (ARI-C/P; Stringaris, Goodman, Ferdinando, Razdan, Muhrer, Leibenluft, & Brotman, 2012)
The ARI-C/P is a parent- and child report measure that assesses frequency, duration, and threshold of child irritability symptoms over 6 months. The ARI-C/P contains 6 items that are rated along a 3-point scale (0 = not true, 1 = somewhat true, 2 = certainly true); total scores range from 0-12. A 7th item, not calculated in the total score, assesses level of general impairment caused by the irritability. The ARI-C/P has shown satisfactory internal consistency, discriminant validity, and is adequately described by a one-factor solution in confirmatory factor analyses.
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
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