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Chronic PainNCT07425691

SPACE for Youth With Chronic Pain

An observational study of Chronic Pain, run by Children's Hospital of Philadelphia at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Chronic Pain
What is being tested?
Supportive Parenting for Anxious Childhood Emotions - Pain
How many people
39 participants
Where
2 sitesUnited States
Study dates
13 Mar 2026to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • Child

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Stanford Children's Health

    Palo Alto, California, 94025

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Development of a Parent Training Intervention for Pediatric Patients With Pain

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.

Conditions
Chronic Pain
Being tested
Supportive Parenting for Anxious Childhood Emotions - Pain
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supportive Parenting for Anxious Childhood Emotions - PainBehavioural

    Also called SPACE

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

Study groups in NCT07425691
Study groupRoleWhat they receive
Youth with chronic painYouth 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 painParents 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).
Receives: Behavioral: Supportive Parenting for Anxious Childhood Emotions - Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility - Acceptance

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

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

  2. 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.

    Measured: Post-treatment (6-8 weeks)

  3. 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.

    Measured: Post-treatment (6-8 weeks)

  4. 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

    Measured: Post-treatment (6-8 weeks)

  5. 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

    Measured: Post-treatment (6-8 weeks)

Secondary outcomes (24)
  1. Anxiety - Child

    This 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety scale measures the frequency and intensity of anxiety symptoms in children and adolescents per self- and parent-report. Responses are measured on a 5 point likert scale (1, "never" to 5, "almost always"). It is part of the PROMIS pediatric system and allows for reliable, standardized comparisons across studies. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Youth will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: Baseline

  2. Anxiety - Child

    This 8-item PROMIS Anxiety scale measures the frequency and intensity of anxiety symptoms in children and adolescents per self- and parent-report. Responses are measured on a 5 point likert scale (1, "never" to 5, "almost always"). It is part of the PROMIS pediatric system and allows for reliable, standardized comparisons across studies. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Youth will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: Post-Treatment (6-8 weeks)

  3. Anxiety - Child

    This 8-item PROMIS Anxiety scale measures the frequency and intensity of anxiety symptoms in children and adolescents per self- and parent-report. Responses are measured on a 5 point likert scale (1, "never" to 5, "almost always"). It is part of the PROMIS pediatric system and allows for reliable, standardized comparisons across studies. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Youth will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: 1 month Post-Treatment

  4. Anxiety - Child

    This 8-item PROMIS Anxiety scale measures the frequency and intensity of anxiety symptoms in children and adolescents per self- and parent-report. Responses are measured on a 5 point likert scale (1, "never" to 5, "almost always"). It is part of the PROMIS pediatric system and allows for reliable, standardized comparisons across studies. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Youth will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: 3 months Post-Treatment

  5. Anxiety - Parent

    This 8-item PROMIS Anxiety scale measures the frequency and intensity of anxiety symptoms in children and adolescents per self- and parent-report. Responses are measured on a 5 point likert scale (1, "never" to 5, "almost always"). It is part of the PROMIS pediatric system and allows for reliable, standardized comparisons across studies. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: Baseline

  6. Anxiety - Parent

    This 8-item PROMIS Anxiety scale measures the frequency and intensity of anxiety symptoms in children and adolescents per self- and parent-report. Responses are measured on a 5 point likert scale (1, "never" to 5, "almost always"). It is part of the PROMIS pediatric system and allows for reliable, standardized comparisons across studies. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: Post-Treatment (6-8 weeks)

  7. Anxiety - Parent

    This 8-item PROMIS Anxiety scale measures the frequency and intensity of anxiety symptoms in children and adolescents per self- and parent-report. Responses are measured on a 5 point likert scale (1, "never" to 5, "almost always"). It is part of the PROMIS pediatric system and allows for reliable, standardized comparisons across studies. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: 1 month Post-Treatment

  8. Anxiety - Parent

    This 8-item PROMIS Anxiety scale measures the frequency and intensity of anxiety symptoms in children and adolescents per self- and parent-report. Responses are measured on a 5 point likert scale (1, "never" to 5, "almost always"). It is part of the PROMIS pediatric system and allows for reliable, standardized comparisons across studies. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: 3 months Post-Treatment

  9. Depression - Child

    The PROMIS Depression Short Form evaluates depressive symptoms, including sadness and unhappiness, in pediatric populations in the past 7 days. The Child report form is 8 items. Responses are measured on a 5 point likert scale (1 = never to 5 =almost always). It provides a standardized measure of affective functioning relevant to chronic pain and related conditions. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Youth will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: Baseline

  10. Depression - Child

    The PROMIS Depression Short Form evaluates depressive symptoms, including sadness and unhappiness, in pediatric populations in the past 7 days. The Child report form is 8 items. Responses are measured on a 5 point likert scale (1 = never to 5 =almost always). It provides a standardized measure of affective functioning relevant to chronic pain and related conditions. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Youth will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: Post-Treatment (6-8 weeks)

  11. Depression - Child

    The PROMIS Depression Short Form evaluates depressive symptoms, including sadness and unhappiness, in pediatric populations in the past 7 days. The Child report form is 8 items. Responses are measured on a 5 point likert scale (1 = never to 5 =almost always). It provides a standardized measure of affective functioning relevant to chronic pain and related conditions. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Youth will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: 1 month Post-Treatment

  12. Depression - Child

    The PROMIS Depression Short Form evaluates depressive symptoms, including sadness and unhappiness, in pediatric populations in the past 7 days. The Child report form is 8 items. Responses are measured on a 5 point likert scale (1 = never to 5 =almost always). It provides a standardized measure of affective functioning relevant to chronic pain and related conditions. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Youth will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: 3 months Post-Treatment

  13. Depression - Parent

    The PROMIS Depression Short Form evaluates depressive symptoms, including sadness and unhappiness, in pediatric populations in the past 7 days. The Parent report form is 6 items. Responses are measured on a 5 point likert scale (1 = never to 5 =almost always). It provides a standardized measure of affective functioning relevant to chronic pain and related conditions. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: Baseline

  14. Depression - Parent

    The PROMIS Depression Short Form evaluates depressive symptoms, including sadness and unhappiness, in pediatric populations in the past 7 days. The Parent report form is 6 items. Responses are measured on a 5 point likert scale (1 = never to 5 =almost always). It provides a standardized measure of affective functioning relevant to chronic pain and related conditions. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: Post-Treatment (6-8 weeks)

  15. Depression - Parent

    The PROMIS Depression Short Form evaluates depressive symptoms, including sadness and unhappiness, in pediatric populations in the past 7 days. The Parent report form is 6 items. Responses are measured on a 5 point likert scale (1 = never to 5 =almost always). It provides a standardized measure of affective functioning relevant to chronic pain and related conditions. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: 1 month Post-Treatment

  16. Depression - Parent

    The PROMIS Depression Short Form evaluates depressive symptoms, including sadness and unhappiness, in pediatric populations in the past 7 days. The Parent report form is 6 items. Responses are measured on a 5 point likert scale (1 = never to 5 =almost always). It provides a standardized measure of affective functioning relevant to chronic pain and related conditions. Total scores are calculated by summing each item response. Total scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: 3 months Post-Treatment

  17. Parent Stress

    The Parent Stress Scale is an 18-item self-report scale. Items represent positive (e.g., emotional benefits, personal development) and negative (e.g., demands on resources, restrictions) themes of parenthood. Respondents agree or disagree in terms of their typical relationship with their child. Responses are measured on a 5-point likert scale (1=strongly disagree to 5=strongly agree). A total score is calculated by summing each item score. Overall possible scores on the scale range from 18 - 90. The higher the score, the higher the measured level of Parental stress.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: Baseline

  18. Parent Stress

    The Parent Stress Scale is an 18-item self-report scale. Items represent positive (e.g., emotional benefits, personal development) and negative (e.g., demands on resources, restrictions) themes of parenthood. Respondents agree or disagree in terms of their typical relationship with their child. Responses are measured on a 5-point likert scale (1=strongly disagree to 5=strongly agree). Overall possible scores on the scale range from 18 - 90. A total score is calculated by summing each item score. Overall possible scores on the scale range from 18 - 90. The higher the score, the higher the measured level of Parental stress.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: Post-Treatment (6-8 weeks)

  19. Parent Stress

    The Parent Stress Scale is an 18-item self-report scale. Items represent positive (e.g., emotional benefits, personal development) and negative (e.g., demands on resources, restrictions) themes of parenthood. Respondents agree or disagree in terms of their typical relationship with their child. Responses are measured on a 5-point likert scale (1=strongly disagree to 5=strongly agree). A total score is calculated by summing each item score. Overall possible scores on the scale range from 18 - 90. The higher the score, the higher the measured level of Parental stress.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: 1 month Post-Treatment

  20. Parent Stress

    The Parent Stress Scale is an 18-item self-report scale. Items represent positive (e.g., emotional benefits, personal development) and negative (e.g., demands on resources, restrictions) themes of parenthood. Respondents agree or disagree in terms of their typical relationship with their child. Responses are measured on a 5-point likert scale (1=strongly disagree to 5=strongly agree). A total score is calculated by summing each item score. Overall possible scores on the scale range from 18 - 90. The higher the score, the higher the measured level of Parental stress.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: 3 months Post-Treatment

  21. Parent Accommodation

    The Inventory of Parent Accommodations to Children's Symptoms (IPACS) is an 11-item parent report form that assesses the degree to which parents accommodate their child's pain. Responses are captured on a 5-point likert scale (0, "never" to 4, "always"). A total score is calculated by summing each item score. Overall possible scores range from 0 to 44 with higher scores suggesting greater parental accommodation.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: Baseline

  22. Parent Accommodation

    The Inventory of Parent Accommodations to Children's Symptoms (IPACS) is an 11-item parent report form that assesses the degree to which parents accommodate their child's pain. Responses are captured on a 5-point likert scale (0, "never" to 4, "always"). A total score is calculated by summing each item score. Overall possible scores range from 0 to 44 with higher scores suggesting greater parental accommodation.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: Post-Treatment (6-8 weeks)

  23. Parent Accommodation

    The Inventory of Parent Accommodations to Children's Symptoms (IPACS) is an 11-item parent report form that assesses the degree to which parents accommodate their child's pain. Responses are captured on a 5-point likert scale (0, "never" to 4, "always"). A total score is calculated by summing each item score. Overall possible scores range from 0 to 44 with higher scores suggesting greater parental accommodation.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: 1 month Post-Treatment

  24. Parent Accommodation

    The Inventory of Parent Accommodations to Children's Symptoms (IPACS) is an 11-item parent report form that assesses the degree to which parents accommodate their child's pain. Responses are captured on a 5-point likert scale (0, "never" to 4, "always"). A total score is calculated by summing each item score. Overall possible scores range from 0 to 44 with higher scores suggesting greater parental accommodation.

    Parents will complete this questionnaire at baseline, post-treatment, as well as one- and three-month follow up time points.

    Measured: 3 months Post-Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2026
  2. Study start13 Mar 2026
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07425691
Sponsor's protocol ID
25-023906
Status last verified
Sep 2026
First submitted
16 Feb 2026
Last updated
2 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain, run by Children's Hospital of Philadelphia at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Acceptance (time frame: From enrollment through the end of the treatment (6-8 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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