NCT04277715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 5, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

February 17, 2020

Last Update Submit

September 12, 2023

Conditions

Medically Unexplained Symptoms

Outcome Measures

Primary Outcomes (1)

  • 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.

    Post-treatment (6-8 weeks)

Secondary Outcomes (14)

  • Functional Disability Inventory (FDI; Kashikar-Zuck et al., 2011)

    Pre-treatment; Post-treatment; 3-month follow-up

  • Pediatric Quality of Life Inventory (PedsQL; Varni, Seid, & Kurtin, 2001)

    Pre-treatment; Post-treatment; 3-month follow-up

  • The Symptom Impact Questionnaire-Revised (SIQR; Bennett, Friend, Jones, Ward, Han, & Ross, 2009)

    Pre-treatment; Post-treatment; 3-month follow-up

  • Clinical Global Impression Scale (CGI; National Institutes of Mental Health, 1985)

    Pre-treatment; Post-treatment

  • Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher, Khetarpal, Brent, Cully, Balach, Kaufman, & Neer, 1997)

    Pre-treatment; Post-treatment; 3-month follow-up

  • +9 more secondary outcomes

Study Arms (1)

Parent training

EXPERIMENTAL

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

Interventions

Parent trainingBEHAVIORAL

Parents will learn evidence-based techniques for increasing support and decreasing accommodation of children's chronic symptoms.

Parent training

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Child Study Center, Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wendy Silverman, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 20, 2020

Study Start

April 5, 2021

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

September 14, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)