Parent Training for Youth With Chronic Symptoms

NCT ID: NCT04277715

Last Updated: 2023-09-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-05

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Medically Unexplained Symptoms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Parent training

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.

Group Type EXPERIMENTAL

Parent training

Intervention Type BEHAVIORAL

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

Interventions

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Parent training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Wallace Foundation

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wendy Silverman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale Child Study Center, Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2000027265

Identifier Type: -

Identifier Source: org_study_id

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