Depressive SymptomsNCT03567330
African American Families Fighting Parental Cancer Together
A study testing Family-based attachment-focused intervention and Psychoeducation in people with Depressive Symptoms and Anxiety, run by University of Delaware at 2 sites in United States.
Trial summary
The purpose of this study is to test the usefulness of a family-based program for African American parents/primary caregivers with newly diagnosed solid tumor cancer and their adolescent children. The program is designed to promote family communication reduce and depressive symptoms for adolescence. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety, Parental Stress
- What is being tested?
- Family-based attachment-focused intervention and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Oct 2018to 30 Jun 2024
- 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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents must identify as non-Hispanic Black
- Must be diagnosed for the first time with stage 0, I, II, or III solid tumor cancer (e.g., breast, prostate, colorectal, lung) or hematologic cancer in the last 24 months
- Must be parent or primary caregiver of at least 1 adolescent living (target child) at home (ages 11-21) who has been told about the diagnosis
Who cannot join
- Parents with serious mental health illness that prevents them from participating in the group sessions (e.g., clinically relevant depressive symptomatology as evidenced by the Center for Epidemiological Studies Depression Scale >27)
- Parents with psychotic features or severe cognitive impairment
- Parents not fluent in English.
- Severely depressed adolescents (CDI-2; T-scores of 70 and higher on the total 28-item CDI-2 scale
- Severely anxious adolescents (RCMAS-2; We will use a cutoff score of 71 (T-score) or higher to screen out African American adolescents with severe anxiety) at baseline
- Adolescents with psychotic features
- Adolescents with cognitive impairment (e.g., mental retardation, severe developmental disorders) as evidenced by educational records, parental report and/or clinical impression
- Adolescents currently in active outpatient mental health treatment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Helen F Graham Cancer Center & Research Institute at Christiana Care
Newark, Delaware, 19713
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
The purpose of this study is to test the usefulness of a family-based program for African American parents/primary caregivers with newly diagnosed solid tumor cancer and their adolescent children. The program is designed to promote family communication reduce and depressive symptoms for adolescence.
Read the detailed description
The investigators will offer a 8-week prevention program to help African American parents and caregivers (e.g., grandparents) diagnosed for the first time with Stages 0, I, II, or III solid tumor cancer or hematologic cancer in the last 24 months who are caring for a 11-21 year old child at home who has been told about the parent's cancer diagnosis. Parents and their adolescent child(ren) will first be asked to complete a set of questionnaires that takes about 60 minutes and then will be told within 2 to 4 weeks whether they have been assigned to 1 of 2 programs that will get chosen by chance, like flipping a coin. Neither the families nor the researchers will choose what program is assigned. Both programs are designed to offer help coping with cancer. Both short- and long-term effects of the program will be evaluated.
Program A involves just parents attending five educational sessions every other week (1 hour/session) with a group of parents who are also coping with cancer with specially trained group leaders. Adolescent children will not participate in these group sessions; this is the treatment as usual comparison group as most cancer centers do not meet with adolescent children who have parents diagnosed with cancer.
Program B involves five group sessions (2 hours/session) every other week with other families like them that include adolescents in some of the sessions and parents and adolescents together in other sessions with specially trained group leaders.
The primary, secondary, and exploratory aims of this research are:
Primary Aim:
Aim 1. Compare the efficacy of Families Fighting Cancer Together (FFCT) to Treatment-as-Usual (TAU) in reducing depressive symptoms (CDI) in AA adolescents at post-treatment using an intention-to-treat (ITT) analysis.
Secondary Aim:
Aim 2. Compare the efficacy of Families Fighting Cancer Together (FFCT) to Treatment-as-Usual (TAU) in reducing parental stress (PCQ) in AA parents at post-treatment using ITT analysis.
Exploratory Aims:
Aim 3a. Determine trajectories of adolescent depressive symptoms (CDI), anxiety (RCMAS), and parental stress (PCQ) from baseline to 12-month follow-up.
Aim 3b. Determine whether perceived levels of group support (HGE), adolescent gender and age, parent's marital and socioeconomic status, and parent's cancer staging modify the effects of treatment on adolescent depression (CDI) and anxiety (RCMAS).
Aim 3c. Determine whether pre-post changes in parent-adolescent attachment and communication mediate the association between treatment and adolescent depressive symptoms (CDI) and anxiety (RCMAS) at 6- and 12-month follow-ups.
- Conditions
- Depressive Symptoms, Anxiety, Parental Stress
- Being tested
- Family-based attachment-focused intervention, Psychoeducation
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based attachment-focused interventionBehavioural
5 2-hour biweekly sessions involving parent and/or adolescent(s).
PsychoeducationBehavioural
Provides equivalent number of American Cancer Society psychoeducational sessions involving only parents.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Family-based attachment-focused intervention for families where parent/caregiver is within 12 months of first diagnosis of a stage I-III solid tumor cancer. Receives: Behavioral: Family-based attachment-focused intervention |
| Psychoeducation | Active comparator | Provides equivalent number of American Cancer Society psychoeducational sessions. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce 8-week depressive symptoms among African American adolescents on the Child Depression Inventory (CDI-2)
Compare the efficacy of Families Fighting Cancer Together (FFCT) to Psychoeducation (PED) in reducing Child Depression Inventory symptoms (CDI-2) in AA adolescents at post-treatment using an intention-to-treat (ITT) analysis.
Measured: Baseline to 8 weeks (end of treatment)
Secondary outcomes (1)
Reduce 8-week parental stress among African American parents on the Parenting Concerns Questionnaire (PCQ)
Compare the efficacy of Families Fighting Cancer Together (FFCT) to Psychoeducation (PED) in reducing parenting stress on the Parenting Concerns Questionnaire (PCQ) in AA parents at post-treatment using ITT analysis.
Measured: Baseline to 8 weeks (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start2 Oct 2018
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Why it stopped: Insufficient patients meet eligibility requirements.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group (cluster) randomized trial. Total number of participants is 200, including 100 men and 100 women.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- Helen F. Graham Cancer Center & Research Institute at Christiana Care, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Responsible party
- Principal investigator, Adam Davey, University of Delaware
- Investigators
- Adam Davey, Ph.D., Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567330
- Sponsor's protocol ID
- 1165185-1
- Status last verified
- Nov 2024
- First submitted
- 23 May 2018
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McKinney NS, Virtue S, Lewis FM, Willis AI, Pettyjohn T, Harmon LR, Davey A. Study protocol: a randomized control trial of African American families fighting parental cancer together. BMC Cancer. 2018 Nov 20;18(1):1140. doi: 10.1186/s12885-018-5052-8.
PubMed 30453906
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African American Families Fighting Parental Cancer Together
- ClinicalTrials.gov ID
- NCT03567330
- Acronym / sponsor ID
- 1165185-1
- Conditions
- Depressive Symptoms, Anxiety, Parental Stress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient patients meet eligibility requirements.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- Helen F. Graham Cancer Center & Research Institute at Christiana Care, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 25 Jun 2018 (actual)
- 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.
The purpose of this study is to test the usefulness of a family-based program for African American parents/primary caregivers with newly diagnosed solid tumor cancer and their adolescent children. The program is designed to promote family communication reduce and depressive symptoms for adolescence.
Detailed description
The investigators will offer a 8-week prevention program to help African American parents and caregivers (e.g., grandparents) diagnosed for the first time with Stages 0, I, II, or III solid tumor cancer or hematologic cancer in the last 24 months who are caring for a 11-21 year old child at home who has been told about the parent's cancer diagnosis. Parents and their adolescent child(ren) will first be asked to complete a set of questionnaires that takes about 60 minutes and then will be told within 2 to 4 weeks whether they have been assigned to 1 of 2 programs that will get chosen by chance, like flipping a coin. Neither the families nor the researchers will choose what program is assigned. Both programs are designed to offer help coping with cancer. Both short- and long-term effects of the program will be evaluated.
Program A involves just parents attending five educational sessions every other week (1 hour/session) with a group of parents who are also coping with cancer with specially trained group leaders. Adolescent children will not participate in these group sessions; this is the treatment as usual comparison group as most cancer centers do not meet with adolescent children who have parents diagnosed with cancer.
Program B involves five group sessions (2 hours/session) every other week with other families like them that include adolescents in some of the sessions and parents and adolescents together in other sessions with specially trained group leaders.
The primary, secondary, and exploratory aims of this research are:
Primary Aim:
Aim 1. Compare the efficacy of Families Fighting Cancer Together (FFCT) to Treatment-as-Usual (TAU) in reducing depressive symptoms (CDI) in AA adolescents at post-treatment using an intention-to-treat (ITT) analysis.
Secondary Aim:
Aim 2. Compare the efficacy of Families Fighting Cancer Together (FFCT) to Treatment-as-Usual (TAU) in reducing parental stress (PCQ) in AA parents at post-treatment using ITT analysis.
Exploratory Aims:
Aim 3a. Determine trajectories of adolescent depressive symptoms (CDI), anxiety (RCMAS), and parental stress (PCQ) from baseline to 12-month follow-up.
Aim 3b. Determine whether perceived levels of group support (HGE), adolescent gender and age, parent's marital and socioeconomic status, and parent's cancer staging modify the effects of treatment on adolescent depression (CDI) and anxiety (RCMAS).
Aim 3c. Determine whether pre-post changes in parent-adolescent attachment and communication mediate the association between treatment and adolescent depressive symptoms (CDI) and anxiety (RCMAS) at 6- and 12-month follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group (cluster) randomized trial. Total number of participants is 200, including 100 men and 100 women.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Family-based attachment-focused interventionFamily-based attachment-focused intervention for families where parent/caregiver is within 12 months of first diagnosis of a stage I-III solid tumor cancer. |
| Psychoeducation | Active comparator | Behavioral: PsychoeducationProvides equivalent number of American Cancer Society psychoeducational sessions. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parents must identify as non-Hispanic Black
- Must be diagnosed for the first time with stage 0, I, II, or III solid tumor cancer (e.g., breast, prostate, colorectal, lung) or hematologic cancer in the last 24 months
- Must be parent or primary caregiver of at least 1 adolescent living (target child) at home (ages 11-21) who has been told about the diagnosis
Key exclusion criteria (8 listed)
- Parents with serious mental health illness that prevents them from participating in the group sessions (e.g., clinically relevant depressive symptomatology as evidenced by the Center for Epidemiological Studies Depression Scale >27)
- Parents with psychotic features or severe cognitive impairment
- Parents not fluent in English.
- Severely depressed adolescents (CDI-2; T-scores of 70 and higher on the total 28-item CDI-2 scale
- Severely anxious adolescents (RCMAS-2; We will use a cutoff score of 71 (T-score) or higher to screen out African American adolescents with severe anxiety) at baseline
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 |
|---|---|---|
| Family-based attachment-focused intervention5 2-hour biweekly sessions involving parent and/or adolescent(s). | Behavioural | Experimental |
| PsychoeducationProvides equivalent number of American Cancer Society psychoeducational sessions involving only parents. | Behavioural | Psychoeducation |
Primary outcome
Reduce 8-week depressive symptoms among African American adolescents on the Child Depression Inventory (CDI-2)
Time frame: Baseline to 8 weeks (end of treatment)
Compare the efficacy of Families Fighting Cancer Together (FFCT) to Psychoeducation (PED) in reducing Child Depression Inventory symptoms (CDI-2) in AA adolescents at post-treatment using an intention-to-treat (ITT) analysis.
1 secondary outcome
Reduce 8-week parental stress among African American parents on the Parenting Concerns Questionnaire (PCQ)
Time frame: Baseline to 8 weeks (end of treatment)
Results and safety
The study was stopped early (reason given: Insufficient patients meet eligibility requirements.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Results publication: PubMed 30453906McKinney NS, Virtue S, Lewis FM, Willis AI, Pettyjohn T, Harmon LR, Davey A. Study protocol: a randomized control trial of African American families fighting parental cancer together. BMC Cancer. 2018 Nov 20;18(1):1140. doi: 10.1186/s12885-018-5052-8.
- Related InfoLink provided by the sponsor.
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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.
Adam Davey, Ph.D. principal investigator
University of Delaware
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based attachment-focused intervention and Psychoeducation in people with Depressive Symptoms and Anxiety, run by University of Delaware 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 8 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: stopped early, as of the sponsor's last update on 22 Nov 2024. 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?
The study was stopped early (reason given: Insufficient patients meet eligibility requirements.). Results are not available in the source record.
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?
Reduce 8-week depressive symptoms among African American adolescents on the Child Depression Inventory (CDI-2) (time frame: Baseline to 8 weeks (end of treatment)). 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 NCT03567330, which also lists 1 linked publication.
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 22 Nov 2024.