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Parent Training for Youth With Chronic Symptoms

Primary Purpose

Medically Unexplained Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent training
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medically Unexplained Symptoms

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale Child Study Center, Yale University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parent training

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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).
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.

Full Information

First Posted
February 17, 2020
Last Updated
September 12, 2023
Sponsor
Yale University
Collaborators
Wallace Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04277715
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Wallace Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medically Unexplained Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent training
Intervention Description
Parents will learn evidence-based techniques for increasing support and decreasing accommodation of children's chronic symptoms.
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1996)
Description
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)
Secondary Outcome Measure Information:
Title
Functional Disability Inventory (FDI; Kashikar-Zuck et al., 2011)
Description
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
Title
Pediatric Quality of Life Inventory (PedsQL; Varni, Seid, & Kurtin, 2001)
Description
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
Title
The Symptom Impact Questionnaire-Revised (SIQR; Bennett, Friend, Jones, Ward, Han, & Ross, 2009)
Description
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
Title
Clinical Global Impression Scale (CGI; National Institutes of Mental Health, 1985)
Description
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
Title
Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher, Khetarpal, Brent, Cully, Balach, Kaufman, & Neer, 1997)
Description
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
Title
Children's Depression Inventory (CDI-2; Kovacs, 2011).
Description
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
Title
Family Accommodation Scale - Anxiety (FASA; Lebowitz et al., 2013; Lebowitz, Marin, & Silverman, 2019)
Description
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
Title
Parenting Stress Index, 4th Edition, Short-Form (PSI-4-SF; Abidin, 2012)
Description
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
Title
The Client Credibility Questionnaire (CCQ; Borkovec & Nau, 1972)
Description
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)
Title
Inventory of Parent Accommodations of Children's Symptoms (IPACS; Harrison, Peterson, Short, & Wetterneck, 2016)
Description
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
Title
Child's Report of Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1988)
Description
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
Title
Perceived Stress Scale (PSS: Cohen, Kamarck, Mermelstein, 1983)
Description
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
Title
Child Anxiety Sensitivity Index (CASI; Silverman, Fleisig, Rabian, & Peterson, 1991)
Description
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
Title
Affective Reactivity Index-Child and Parent versions (ARI-C/P; Stringaris, Goodman, Ferdinando, Razdan, Muhrer, Leibenluft, & Brotman, 2012)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Silverman, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Child Study Center, Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Parent Training for Youth With Chronic Symptoms

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