DepressionNCT04780620
Group Intervention to Improve Parent-Adolescent Relationships
A study testing Parent Intervention Group in people with Depression, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
This pilot randomized control trial investigates whether a psychosocial intervention targeting parent-adolescent conflict is feasible and acceptable, in preparation for a future trial that will test whether the intervention can improve treatment outcomes for youth diagnosed with depression. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Parent Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jul 2021to Aug 2023
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- parent/caregiver of an adolescent aged 13-18 years
- the adolescent is referred for outpatient services at CAMH
- adolescent has significant depressive symptoms, having either: a) a self-reported score of 23 or higher on the Mood and Feelings Questionnaire; or b) a depression diagnosis based on the Kiddie-Schedule for Affective Disorders and Schizophrenia from the last 3 months
- parent or youth endorse problematic levels of conflict in their relationship, having either: a) a total score of 9 or greater on the adolescent version, or a total score of 11 or greater on the parent version, of the 20-item Conflict Behavior Questionnaire; or b) a rating of 2 or higher on item 2 or 3 (Item 2 "getting along with your mother/mother figure;" item 3 "getting along with your father/father figure") of the youth-report version of the Columbia Impairment Scale
- both parent and adolescent speak, read, and write English at a Grade 6 level or above
Who cannot join
- the adolescent's primary diagnosis is not depression, based on information in their health record
- the adolescent has been diagnosed with bipolar disorder (I or II), schizophrenia, moderate-severe eating disorder, moderate-severe substance use disorder, or an intellectual disability (as the clinical and family needs of these adolescents are not likely to be sufficiently addressed by a general group for parents of adolescents with depression), or requires immediate hospitalization for suicide risk
- the parent/caregiver does not consent to participate
- (specific only to the virtual format of the study) the parent is not comfortable communicating via email or using WebEx for virtual appointments (as the use of WebEx and email is required for study visits and for participation in the parent intervention)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Madison Aitken, Ph.D., 416-535-8501 ext. 34091, madison.aitken@camh.ca
Yola El Dahr, M.Sc., yola.eldahr@camh.ca
About this study
Official title: Addressing Parent-Adolescent Relationship Issues in the Treatment of Adolescent Depression: A Pilot Study
This pilot randomized control trial investigates whether a psychosocial intervention targeting parent-adolescent conflict is feasible and acceptable, in preparation for a future trial that will test whether the intervention can improve treatment outcomes for youth diagnosed with depression.
Read the detailed description
Parent involvement in psychosocial interventions for youth diagnosed with internalizing disorders has been cited as a contributor to better outcomes for these youth, and parent components have been included in several evidence-based interventions for adolescent mental health problems. Additionally, youth experiencing mood and behaviour changes that come about as a result of a depressive episode can lead to frustrated/overprotective reactions from parents, which can contribute to worse outcomes for these adolescents. Interventions focused on addressing parent-adolescent conflict and reducing negative interactions can potentially support recovery from depression and reduce episode relapse. However, there is very little research on including parent components in psychosocial interventions specifically aimed at youth depression. This randomized control trial aims to fill this gap by randomizing parents of youth receiving treatment for depression into either 1) an 8-week virtual or in-person group parent intervention, or 2) usual care.
Participants will be parents or caregivers (for simplicity, the term "parent" is used to refer to parents or caregivers) of adolescents aged 13-18 with depression who are referred for outpatient services at a mental health research hospital in Toronto, Canada. Their adolescents will also participate in the study in order to provide multi-informant data; however, should adolescents decline to participate in the study, their parent will still be able to take part.
Parents will complete a combination of questionnaire and observationally coded measures at pre- and posttreatment, along with questionnaire measures at mid-treatment and 3 months follow-up. Adolescents will only complete questionnaire measures for all four time points.
- Conditions
- Depression
- Being tested
- Parent Intervention Group
- Keywords
- youth depression, adolescent depression, psychosocial intervention, parent-adolescent conflict
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Intervention GroupOther
Parents will be involved in 8 weekly sessions.
| Study group | Role | What they receive |
|---|---|---|
| Parent Intervention Group | Experimental | The parent intervention group will undergo 8 weekly, manualized group sessions, with between 6 and 10 parent participants. Sessions are structured and follow an agenda including check-in and review of home practice, discussion of a skill or strategy, and review and assignment of home practice. Group sessions are held weekly for 1.5 hours and include both didactic, discussion, and practice elements, as well as assigned home practice. Receives: Other: Parent Intervention Group |
| Usual Care Group | No intervention | Parents in the usual care condition will be involved in their adolescent's care as is standard in our clinical program. With adolescent consent, parents are invited to participate in a single, 2-hour orientation session for parents/caregivers that provides information about depression, as well as the role of sleep, diet, and exercise in improving mood. Based on adolescent preference, parents can also attend regular psychiatric appointments with their adolescent, in which they will receive further information about depression and may receive and provide information about their adolescent's depression symptoms and response to psychosocial and pharmacological interventions. This control condition will allow us to determine whether the parent intervention is more effective than a relevant clinical alternative. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Outcomes
Feasibility defined as:
- Participant recruitment rates, retention in the study, and completion of measures across time points
- Parent satisfaction with the intervention
- Parent attendance at the group and dropout from the group
- Clinician fidelity to the intervention
Measured: 2 years (study duration)
Secondary outcomes (4)
Parent Expressed Emotion
Parent report on the Family Questionnaire; Adolescent report on the Level of Expressed Emotion questionnaire; Observational coding of parent Five Minute Speech Sample
Measured: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up
Parent Affective Responding
Parent and adolescent report on the Coping with Children's Negative Emotions Scale and the Responding to Adolescents' Happy Affect Scale
Measured: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up
Parent-Adolescent Conflict
Parent and adolescent report on the Issues Checklist
Measured: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up
Adolescent depression
Adolescent self-report on the Mood and Feelings Questionnaire
Measured: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start28 Jul 2021
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madison Aitken, Centre for Addiction and Mental Health
- Investigators
- Madison Aitken, Ph.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780620
- Sponsor's protocol ID
- 098-2020
- Status last verified
- Dec 2022
- First submitted
- 1 Mar 2021
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing IPD has not currently been approved by our Research Ethics Board and would also require a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Parent-Adolescent Relationship Issues in the Treatment of Adolescent Depression: A Pilot Study
- ClinicalTrials.gov ID
- NCT04780620
- Acronym / sponsor ID
- 098-2020
- Conditions
- Depression
- Keywords
- youth depression, adolescent depression, psychosocial intervention, parent-adolescent conflict
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 3 Mar 2021 (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.
This pilot randomized control trial investigates whether a psychosocial intervention targeting parent-adolescent conflict is feasible and acceptable, in preparation for a future trial that will test whether the intervention can improve treatment outcomes for youth diagnosed with depression.
Detailed description
Parent involvement in psychosocial interventions for youth diagnosed with internalizing disorders has been cited as a contributor to better outcomes for these youth, and parent components have been included in several evidence-based interventions for adolescent mental health problems. Additionally, youth experiencing mood and behaviour changes that come about as a result of a depressive episode can lead to frustrated/overprotective reactions from parents, which can contribute to worse outcomes for these adolescents. Interventions focused on addressing parent-adolescent conflict and reducing negative interactions can potentially support recovery from depression and reduce episode relapse. However, there is very little research on including parent components in psychosocial interventions specifically aimed at youth depression. This randomized control trial aims to fill this gap by randomizing parents of youth receiving treatment for depression into either 1) an 8-week virtual or in-person group parent intervention, or 2) usual care.
Participants will be parents or caregivers (for simplicity, the term "parent" is used to refer to parents or caregivers) of adolescents aged 13-18 with depression who are referred for outpatient services at a mental health research hospital in Toronto, Canada. Their adolescents will also participate in the study in order to provide multi-informant data; however, should adolescents decline to participate in the study, their parent will still be able to take part.
Parents will complete a combination of questionnaire and observationally coded measures at pre- and posttreatment, along with questionnaire measures at mid-treatment and 3 months follow-up. Adolescents will only complete questionnaire measures for all four time points.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Intervention Group | Experimental | Other: Parent Intervention GroupThe parent intervention group will undergo 8 weekly, manualized group sessions, with between 6 and 10 parent participants. Sessions are structured and follow an agenda including check-in and review of home practice, discussion of a skill or strategy, and review and assignment of home practice. Group sessions are held weekly for 1.5 hours and include both didactic, discussion, and practice elements, as well as assigned home practice. |
| Usual Care Group | No intervention | –Parents in the usual care condition will be involved in their adolescent's care as is standard in our clinical program. With adolescent consent, parents are invited to participate in a single, 2-hour orientation session for parents/caregivers that provides information about depression, as well as the role of sleep, diet, and exercise in improving mood. Based on adolescent preference, parents can also attend regular psychiatric appointments with their adolescent, in which they will receive further information about depression and may receive and provide information about their adolescent's depression symptoms and response to psychosocial and pharmacological interventions. This control condition will allow us to determine whether the parent intervention is more effective than a relevant clinical alternative. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- parent/caregiver of an adolescent aged 13-18 years
- the adolescent is referred for outpatient services at CAMH
- adolescent has significant depressive symptoms, having either: a) a self-reported score of 23 or higher on the Mood and Feelings Questionnaire; or b) a depression diagnosis based on the Kiddie-Schedule for Affective Disorders and Schizophrenia from the last 3 months
- parent or youth endorse problematic levels of conflict in their relationship, having either: a) a total score of 9 or greater on the adolescent version, or a total score of 11 or greater on the parent version, of the 20-item Conflict Behavior Questionnaire; or b) a rating of 2 or higher on item 2 or 3 (Item 2 "getting along with your mother/mother figure;" item 3 "getting along with your father/father figure") of the youth-report version of the Columbia Impairment Scale
- both parent and adolescent speak, read, and write English at a Grade 6 level or above
Key exclusion criteria (4 listed)
- the adolescent's primary diagnosis is not depression, based on information in their health record
- the adolescent has been diagnosed with bipolar disorder (I or II), schizophrenia, moderate-severe eating disorder, moderate-severe substance use disorder, or an intellectual disability (as the clinical and family needs of these adolescents are not likely to be sufficiently addressed by a general group for parents of adolescents with depression), or requires immediate hospitalization for suicide risk
- the parent/caregiver does not consent to participate
- (specific only to the virtual format of the study) the parent is not comfortable communicating via email or using WebEx for virtual appointments (as the use of WebEx and email is required for study visits and for participation in the parent intervention)
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 |
|---|---|---|
| Parent Intervention GroupParents will be involved in 8 weekly sessions. | Other | Parent Intervention Group |
Primary outcome
Feasibility Outcomes
Time frame: 2 years (study duration)
Feasibility defined as: * Participant recruitment rates, retention in the study, and completion of measures across time points * Parent satisfaction with the intervention * Parent attendance at the group and dropout from the group * Clinician fidelity to the intervention
4 secondary outcomes
Parent Expressed Emotion
Time frame: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up
Parent Affective Responding
Time frame: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up
Parent-Adolescent Conflict
Time frame: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up
Adolescent depression
Time frame: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No. Sharing IPD has not currently been approved by our Research Ethics Board and would also require a data sharing agreement.
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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.
Madison Aitken, Ph.D. principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Intervention Group in people with Depression, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Dec 2022. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Madison Aitken, Ph.D. (416-535-8501 ext. 34091, madison.aitken@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Outcomes (time frame: 2 years (study duration)). 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 9 Dec 2022; AzTrials last refreshed its copy on 3 Nov 2026.