CancerNCT02758639
Wonders & Worries: A Clinical Trial of a Psychosocial Intervention for Children Who Have a Parent With Cancer
A study testing Wonders & Worries Psychosocial Intervention in people with Cancer and Psychological Adjustment, run by University of Texas at Austin at 1 site in United States.
Trial summary
Parental cancer can cause substantial behavioral and emotional distress in both parent and child. Parents struggle with talking with their child about their cancer and supporting the child during treatment. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Cancer, Psychological Adjustment
- What is being tested?
- Wonders & Worries Psychosocial Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 19 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Families with children ages 5-14 at time of study. Children have a parent with early stage cancer, and are English-speaking.
Who cannot join
- Children are not living in the home with the ill parent at least 50% of the time. Non-English speaking families.
Trial locations and contacts
1 site in 1 country.
About this study
Parental cancer can cause substantial behavioral and emotional distress in both parent and child. Parents struggle with talking with their child about their cancer and supporting the child during treatment. Over 73% of patients with children desire information and services to support their children yet only 9% of these families report receiving this support. The purpose of this study is to evaluate the Wonders \& Worries psychosocial intervention designed for children ages 5-14 who have a parent diagnosed with early stage cancer.This study is a randomized controlled clinical trial (RCT) evaluating the Wonders \& Worries group and individual intervention for school age children (5 -14 years old) who have a parent with cancer. Families will be enrolled at the time of initial parent consultation, given informed consent, and then randomized either to the intervention group of 30 families or the wait-listed control group of 30 families. Both groups will be given a series of standardized validated assessment instruments including the Revised Children's Manifest Anxiety Scale (RCMAS), the Child Behavior Checklist (CBCL), and the Family Communication Scale FACES IV at baseline, post intervention, and 8 week follow up. Upon completion of the follow up measures, families in the wait-listed control group will be enrolled into the intervention. Parent exit interviews for both groups will be used to measure parent-reported child outcomes and program utility.
Read the detailed description
The purpose of this study is to evaluate the Wonders \& Worries psychosocial intervention designed for children ages 5-14 who have a parent diagnosed with early stage cancer. The Wonders \& Worries program curriculum is a psychosocial intervention that was designed to address the communication and distress issues raised in prior descriptive research and to respond to the limitations of current research. The goals of the program are to improve children's behavioral-emotional adjustment to their parent's cancer, improve parenting behavior (parenting quality, skills and self-efficacy), and increase family communication about the illness. The aim of the current study is to evaluate the efficacy of the Wonders \& Worries program on child and parent outcomes within a randomized clinical trial.
Wonders \& Worries is an Austin based non-profit agency. Wonders \& Worries works with families in all stages of survivorship, who are affected by any serious or chronic physical illness.
The fully scripted intervention involves 6 group or individual sessions for the children, each of which is briefly summarized, in Table 1. Families will be enrolled at the time of initial parent consultation at Wonders \& Worries, given informed consent, and then randomized either to the intervention group of 30 families or the wait-listed control group of 30 families. Both groups will be given a series of standardized validated assessment instruments including the Revised Children's Manifest Anxiety Scale (RCMAS), the Child Behavior Checklist (CBCL), the Family Communication Scale FACES IV, and the AMMI-EC3- About My Mommy's Illness at baseline, post intervention, and 8 week follow up. Upon completion of the follow up measures, families in the wait-listed control group will be enrolled into the intervention. Parent exit interviews for both groups will be used to measure parent-reported child outcomes and program utility.
The intervention will be provided by Wonders \& Worries certified child life specialists. Child life specialists are professionals trained to help children and their families understand and manage challenging life events and stressful health care experiences. By using play, recreation, education, self-expression and theories of child development, these specialists help promote the psychological well-being and optimum development of children and families faced with stressful situations. At Wonders \& Worries all services are provided by master's prepared certified child life specialists.
- Conditions
- Cancer, Psychological Adjustment
- Being tested
- Wonders & Worries Psychosocial Intervention
- Keywords
- parental cancer, children psychosocial adjustment, psychosocial intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wonders & Worries Psychosocial InterventionBehavioural
Session 1: Getting to Know Each Other The goal is to create a sense of safety within the group so that the children feel comfortable discussing difficult topics. Session 2: Cancer Education to provide developmentally appropriate education about the illness, treatment, and side effects. Session 3: Cancer Treatment Center Tour: This session consists of a treatment center tour and education about treatment plan involved in family's care in a safe environment. Session 4: Feelings: The focus of this session is expression and validation of all feelings the children may experience. Session 5: Stress and Coping: Goal is to emphasize the different ways individuals cope and differentiate positive vs. negative coping strategies. Session 6: Hopes for the Future/Closure: An emphasis is made on the idea that positive things may evolve from the most difficult circumstances.
| Study group | Role | What they receive |
|---|---|---|
| W & W Intervention | Experimental | Wonders \& Worries Psychosocial intervention is a 6 week group or individual sessions for children who have a parent with cancer focusing on psycho-educational information about cancer, treatment and its side effects, feelings expression, positive coping strategies, and family communication about the illness. Receives: Behavioral: Wonders & Worries Psychosocial Intervention |
| Wait list control | Other | Wait list group will complete baseline, 6 week and 8 week follow up measures and then will be enrolled to receive W \& W intervention. Receives: Behavioral: Wonders & Worries Psychosocial Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child's Anxiety level (RCMAS) from baseline to 6 weeks and 8 week follow up
Revised Children's Manifest Anxiety Scale - child self report
Measured: Baseline, 6 week, 8 week follow up
Change in Child's Emotional/Behavioral Status (CBCL) from baseline to 6 weeks and 8 week follow up
Child Behavior Checklist - parent report
Measured: Baseline, 6 week, 8 week follow up
Change in Family Communication Scale FACES IV from baseline to 6 weeks and 8 week follow up
parent \& child report
Measured: Baseline, 6 week, 8 week follow up
Change in The Family Quality of Life Scale (FQOL) from baseline to 6 weeks and 8 week follow up
parent \& child report
Measured: Baseline, 6 week, 8 week follow up
Change in Cancer Self-Efficacy Scale (CASE) from baseline to 6 weeks and 8 week follow up
parent report of parenting self efficacy
Measured: Baseline, 6 week, 8 week follow up
Change in Spielberger State-Trait Anxiety Inventory (STAI) from baseline to 6 weeks and 8 week follow up
parent self report of anxiety
Measured: Baseline, 6 week, 8 week follow up
Change in Depression scale (CES-D) from baseline to 6 weeks and 8 week follow up
parent self report of depression
Measured: Baseline, 6 week, 8 week follow up
Change in Parenting Concerns Questionnaire (PCQ) for adults with cancer from baseline to 6 weeks and 8 week follow up
parent self report
Measured: Baseline, 6 week, 8 week follow up
Change in child's worries about their parent's illness from baseline to 6 weeks and 8 week follow up
child self report of worries related to parent's illness AMMI-EC3- About My Mommy's Illness
Measured: Baseline, 6 week, 8 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startSep 2015
- Primary completion19 Aug 2018
- Study completion19 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Wonders & Worries
- Responsible party
- Sponsor
- Investigators
- Farya Phillips, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758639
- Sponsor's protocol ID
- 201502573
- Status last verified
- Oct 2018
- First submitted
- 25 Apr 2016
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Phillips F, Prezio EA. Wonders & Worries: evaluation of a child centered psychosocial intervention for families who have a parent/primary caregiver with cancer. Psychooncology. 2017 Jul;26(7):1006-1012. doi: 10.1002/pon.4120. Epub 2016 Mar 8.
PubMed 26954773Phillips F, Prezio EA, Currin-McCulloch J, Jones BL. Wonders & Worries: A randomized clinical trial of a psychosocial intervention for children who have a parent with cancer. Psychooncology. 2022 Aug;31(8):1399-1411. doi: 10.1002/pon.5943. Epub 2022 Apr 29.
PubMed 35470518
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wonders & Worries: A Clinical Trial of a Psychosocial Intervention for Children Who Have a Parent With Cancer
- ClinicalTrials.gov ID
- NCT02758639
- Acronym / sponsor ID
- 201502573
- Conditions
- Cancer, Psychological Adjustment
- Keywords
- parental cancer, children psychosocial adjustment, psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Wonders & Worries
- Study start
- Sep 2015 (actual)
- Primary completion
- 19 Aug 2018 (actual)
- Study completion
- 19 Aug 2018 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parental cancer can cause substantial behavioral and emotional distress in both parent and child. Parents struggle with talking with their child about their cancer and supporting the child during treatment. Over 73% of patients with children desire information and services to support their children yet only 9% of these families report receiving this support. The purpose of this study is to evaluate the Wonders \& Worries psychosocial intervention designed for children ages 5-14 who have a parent diagnosed with early stage cancer.This study is a randomized controlled clinical trial (RCT) evaluating the Wonders \& Worries group and individual intervention for school age children (5 -14 years old) who have a parent with cancer. Families will be enrolled at the time of initial parent consultation, given informed consent, and then randomized either to the intervention group of 30 families or the wait-listed control group of 30 families. Both groups will be given a series of standardized validated assessment instruments including the Revised Children's Manifest Anxiety Scale (RCMAS), the Child Behavior Checklist (CBCL), and the Family Communication Scale FACES IV at baseline, post intervention, and 8 week follow up. Upon completion of the follow up measures, families in the wait-listed control group will be enrolled into the intervention. Parent exit interviews for both groups will be used to measure parent-reported child outcomes and program utility.
Detailed description
The purpose of this study is to evaluate the Wonders \& Worries psychosocial intervention designed for children ages 5-14 who have a parent diagnosed with early stage cancer. The Wonders \& Worries program curriculum is a psychosocial intervention that was designed to address the communication and distress issues raised in prior descriptive research and to respond to the limitations of current research. The goals of the program are to improve children's behavioral-emotional adjustment to their parent's cancer, improve parenting behavior (parenting quality, skills and self-efficacy), and increase family communication about the illness. The aim of the current study is to evaluate the efficacy of the Wonders \& Worries program on child and parent outcomes within a randomized clinical trial.
Wonders \& Worries is an Austin based non-profit agency. Wonders \& Worries works with families in all stages of survivorship, who are affected by any serious or chronic physical illness.
The fully scripted intervention involves 6 group or individual sessions for the children, each of which is briefly summarized, in Table 1. Families will be enrolled at the time of initial parent consultation at Wonders \& Worries, given informed consent, and then randomized either to the intervention group of 30 families or the wait-listed control group of 30 families. Both groups will be given a series of standardized validated assessment instruments including the Revised Children's Manifest Anxiety Scale (RCMAS), the Child Behavior Checklist (CBCL), the Family Communication Scale FACES IV, and the AMMI-EC3- About My Mommy's Illness at baseline, post intervention, and 8 week follow up. Upon completion of the follow up measures, families in the wait-listed control group will be enrolled into the intervention. Parent exit interviews for both groups will be used to measure parent-reported child outcomes and program utility.
The intervention will be provided by Wonders \& Worries certified child life specialists. Child life specialists are professionals trained to help children and their families understand and manage challenging life events and stressful health care experiences. By using play, recreation, education, self-expression and theories of child development, these specialists help promote the psychological well-being and optimum development of children and families faced with stressful situations. At Wonders \& Worries all services are provided by master's prepared certified child life specialists.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| W & W Intervention | Experimental | Behavioral: Wonders & Worries Psychosocial InterventionWonders \& Worries Psychosocial intervention is a 6 week group or individual sessions for children who have a parent with cancer focusing on psycho-educational information about cancer, treatment and its side effects, feelings expression, positive coping strategies, and family communication about the illness. |
| Wait list control | Other | Behavioral: Wonders & Worries Psychosocial InterventionWait list group will complete baseline, 6 week and 8 week follow up measures and then will be enrolled to receive W \& W intervention. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Families with children ages 5-14 at time of study. Children have a parent with early stage cancer, and are English-speaking.
Key exclusion criteria (1 listed)
- Children are not living in the home with the ill parent at least 50% of the time. Non-English speaking families.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wonders & Worries Psychosocial InterventionSession 1: Getting to Know Each Other The goal is to create a sense of safety within the group so that the children feel comfortable discussing difficult topics. Session 2: Cancer Education to provide developmentally appropriate education about the illness, treatment, and side effects. Session 3: Cancer Treatment Center Tour: This session consists of a treatment center tour and education about treatment plan involved in family's care in a safe environment. Session 4: Feelings: The focus of this session is expression and validation of all feelings the children may experience. Session 5: Stress and Coping: Goal is to emphasize the different ways individuals cope and differentiate positive vs. negative coping strategies. Session 6: Hopes for the Future/Closure: An emphasis is made on the idea that positive things may evolve from the most difficult circumstances. | Behavioural | W & W Intervention, Wait list control |
Primary outcome
Change in Child's Anxiety level (RCMAS) from baseline to 6 weeks and 8 week follow up
Time frame: Baseline, 6 week, 8 week follow up
Revised Children's Manifest Anxiety Scale - child self report
Change in Child's Emotional/Behavioral Status (CBCL) from baseline to 6 weeks and 8 week follow up
Time frame: Baseline, 6 week, 8 week follow up
Child Behavior Checklist - parent report
Change in Family Communication Scale FACES IV from baseline to 6 weeks and 8 week follow up
Time frame: Baseline, 6 week, 8 week follow up
parent \& child report
Change in The Family Quality of Life Scale (FQOL) from baseline to 6 weeks and 8 week follow up
Time frame: Baseline, 6 week, 8 week follow up
parent \& child report
Change in Cancer Self-Efficacy Scale (CASE) from baseline to 6 weeks and 8 week follow up
Time frame: Baseline, 6 week, 8 week follow up
parent report of parenting self efficacy
Change in Spielberger State-Trait Anxiety Inventory (STAI) from baseline to 6 weeks and 8 week follow up
Time frame: Baseline, 6 week, 8 week follow up
parent self report of anxiety
Change in Depression scale (CES-D) from baseline to 6 weeks and 8 week follow up
Time frame: Baseline, 6 week, 8 week follow up
parent self report of depression
Change in Parenting Concerns Questionnaire (PCQ) for adults with cancer from baseline to 6 weeks and 8 week follow up
Time frame: Baseline, 6 week, 8 week follow up
parent self report
Change in child's worries about their parent's illness from baseline to 6 weeks and 8 week follow up
Time frame: Baseline, 6 week, 8 week follow up
child self report of worries related to parent's illness AMMI-EC3- About My Mommy's Illness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Background: PubMed 26954773Phillips F, Prezio EA. Wonders & Worries: evaluation of a child centered psychosocial intervention for families who have a parent/primary caregiver with cancer. Psychooncology. 2017 Jul;26(7):1006-1012. doi: 10.1002/pon.4120. Epub 2016 Mar 8.
- Derived from this study: PubMed 35470518Phillips F, Prezio EA, Currin-McCulloch J, Jones BL. Wonders & Worries: A randomized clinical trial of a psychosocial intervention for children who have a parent with cancer. Psychooncology. 2022 Aug;31(8):1399-1411. doi: 10.1002/pon.5943. Epub 2022 Apr 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farya Phillips, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wonders & Worries Psychosocial Intervention in people with Cancer and Psychological Adjustment, run by University of Texas at Austin at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Child's Anxiety level (RCMAS) from baseline to 6 weeks and 8 week follow up (time frame: Baseline, 6 week, 8 week follow up). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02758639, which also lists 2 linked publications.
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 10 Oct 2018.