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Group Intervention to Improve Parent-Adolescent Relationships

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Parent Intervention Group
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring youth depression, adolescent depression, psychosocial intervention, parent-adolescent conflict

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • parent/caregiver of an adolescent aged 13-18 years
  • adolescent is part of care pathway for depression at the time of the referral to the parent group
  • adolescent has a primary diagnosis of a depressive disorder (Major Depressive Disorder and/or Persistent Depressive Disorder) according to their clinician, and a self-reported score of 23 or higher on the Mood and Feelings Questionnaire
  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Centre for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Parent Intervention Group

Usual Care Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Parent Affective Responding
Parent and adolescent report on the Coping with Children's Negative Emotions Scale and the Responding to Adolescents' Happy Affect Scale
Parent-Adolescent Conflict
Parent and adolescent report on the Issues Checklist
Adolescent depression
Adolescent self-report on the Mood and Feelings Questionnaire

Full Information

First Posted
March 1, 2021
Last Updated
December 7, 2022
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT04780620
Brief Title
Group Intervention to Improve Parent-Adolescent Relationships
Official Title
Addressing Parent-Adolescent Relationship Issues in the Treatment of Adolescent Depression: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
youth depression, adolescent depression, psychosocial intervention, parent-adolescent conflict

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Research personnel involved in data collection will be blind to participants' treatment condition (single blind). In addition, coders for the interaction task and speech sample will be blind to treatment condition (intervention versus control) and measurement time point (baseline vs. posttreatment).
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parent Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Parent Intervention Group
Intervention Description
Parents will be involved in 8 weekly sessions.
Primary Outcome Measure Information:
Title
Feasibility Outcomes
Description
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
Time Frame
2 years (study duration)
Secondary Outcome Measure Information:
Title
Parent Expressed Emotion
Description
Parent report on the Family Questionnaire; Adolescent report on the Level of Expressed Emotion questionnaire; Observational coding of parent Five Minute Speech Sample
Time Frame
Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up
Title
Parent Affective Responding
Description
Parent and adolescent report on the Coping with Children's Negative Emotions Scale and the Responding to Adolescents' Happy Affect Scale
Time Frame
Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up
Title
Parent-Adolescent Conflict
Description
Parent and adolescent report on the Issues Checklist
Time Frame
Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up
Title
Adolescent depression
Description
Adolescent self-report on the Mood and Feelings Questionnaire
Time Frame
Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madison Aitken, Ph.D.
Phone
416-535-8501
Ext
34091
Email
madison.aitken@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madison Aitken, Ph.D.
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madison Aitken, Ph.D.
Phone
416-535-8501
Ext
34091
Email
madison.aitken@camh.ca
First Name & Middle Initial & Last Name & Degree
Yola El Dahr, M.Sc.
Email
yola.eldahr@camh.ca
First Name & Middle Initial & Last Name & Degree
Madison Aitken, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Sharing IPD has not currently been approved by our Research Ethics Board and would also require a data sharing agreement.

Learn more about this trial

Group Intervention to Improve Parent-Adolescent Relationships

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