NCT07425691

Brief Summary

The primary objective is to assess the feasibility and acceptability of a group-based parent training intervention for parents of youth with chronic pain. Secondary objectives include evaluating changes in child functional impairment, pain intensity, and parent accommodation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Mar 2026Jun 2026

First Submitted

Initial submission to the registry

February 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

March 13, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

February 16, 2026

Last Update Submit

April 14, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Feasibility - Acceptance

    Feasibility of intervention as measured by the mean of number of sessions attended. Local session documents will track each session.

    From enrollment through the end of the treatment (6-8 weeks)

  • Acceptability - Client Satisfaction

    Client satisfaction with the intervention will be measured by the patient-reported Client Satisfaction Questionnaire. The Client Satisfaction Questionnaire is an 8-item, widely used, self-report measure for assessing general client satisfaction with mental health services. It uses a 4-point Likert scale for each question. This will be administered to parents, who received the intervention. Total scores range from 8 to 32, with higher scores indicating greater satisfaction. Parents of youth with chronic pain will be asked to complete this measure at the end of the intervention.

    Post-treatment (6-8 weeks)

  • Acceptability - Provider

    Provider will assess the acceptability of the measure by the Acceptability of Intervention Measure. This 4-item measure is measured on a 5-point Likert scale (1 = completely disagree; 5 = completely agree). Scoring involves calculating the mean of the 4 items (range 1-5), with higher scores indicating higher acceptability. Providers will be asked to complete this measure at the end of the intervention.

    Post-treatment (6-8 weeks)

  • Provider Intervention Appropriateness

    Provider will assess the appropriateness of the measure by the Intervention Appropriateness Measure. This 4-item measure is measured on a 5-point Likert scale (1 = completely disagree; 5 = completely agree). Scoring involves calculating the mean of the 4 items (range 1-5), with higher scores indicating higher degree of appropriateness. Providers will be asked to complete this measure at the end of the intervention

    Post-treatment (6-8 weeks)

  • Feasibility - Provider

    Provider will assess the feasibility of the measure by the Feasibility of Intervention Measure. This 4-item measure is measured on a 5-point Likert scale (1 = completely disagree; 5 = completely agree). Scoring involves calculating the mean of the 4 items (range 1-5), with higher scores indicating higher degree of feasibility. Providers will be asked to complete this measure at the end of the intervention

    Post-treatment (6-8 weeks)

Secondary Outcomes (24)

  • Anxiety - Child

    Baseline

  • Anxiety - Child

    Post-Treatment (6-8 weeks)

  • Anxiety - Child

    1 month Post-Treatment

  • Anxiety - Child

    3 months Post-Treatment

  • Anxiety - Parent

    Baseline

  • +19 more secondary outcomes

Study Arms (2)

Youth with chronic pain

Youth with chronic pain will complete questionnaires assessing secondary outcome measures prior to the start of the parent-only group intervention. The parent-only group intervention is 6 weekly, 90 minute sessions held over a secure virtual platform. Sessions will focus on orientation to the group, psychoeducation about pain neuroscience, and the role of parents in pain management, how parents can increase support for their child as well as decrease behaviors that may inadvertently maintain or reinforce pain and pain-related behaviors. Sessions will be recorded to ensure consistency in session content across groups. Homework will be assigned to parents after each session and will be reviewed the following week. Youth with chronic pain will then be asked to complete questionnaires at the end of the intervention, and at 1-month and 3-month follow up time points. Questionnaire completion is expected to take about 20 minutes at each time point.

Parents of youth with chronic pain

Parents of youth with chronic pain will complete questionnaires assessing secondary outcome measures prior to the start of the parent-only group intervention. The parent-only group intervention is 6 weekly, 90 minute sessions held over a secure virtual platform. Sessions will focus on orientation to the group, psychoeducation about pain neuroscience, and the role of parents in pain management, how parents can increase support for their child as well as decrease behaviors that may inadvertently maintain or reinforce pain and pain-related behaviors. Sessions will be recorded to ensure consistency in session content across groups. Homework will be assigned to parents after each session and will be reviewed the following week. Parents of youth with chronic pain will be asked to complete questionnaires at the end of the intervention (45 minutes), and repeat some of the questionnaires at follow up time points (35-40 minutes).

Behavioral: Supportive Parenting for Anxious Childhood Emotions - Pain

Interventions

Originally developed for pediatric anxiety disorders, SPACE equips parents to reduce accommodation while maintaining a warm, empathic stance.

Also known as: SPACE
Parents of youth with chronic pain

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children ages 10-17 years old with a chronic pain condition.

You may qualify if:

  • Children aged 10-17 with chronic pain (≥3 months) and associated functional impairment
  • Parent/guardian living with the child ≥50% of the time
  • Parent and child are fluent in English

You may not qualify if:

  • Pain better explained by another medical condition
  • History of psychosis, bipolar disorder, autism spectrum disorder, or intellectual disability (child)
  • Current emotional, cognitive, or physical barrier to participation for caregiver, as determined by clinical judgment of study personnel
  • Severe psychiatric symptoms requiring immediate intervention
  • Ongoing individual Cognitive Behavioral Therapy (CBT) for pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford Children's Health

Palo Alto, California, 94025, United States

NOT YET RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christina Murphy, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Murphy, PhD

CONTACT

Julia Ney, MA

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 23, 2026

Study Start

March 13, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Locations