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Group Intervention to Improve Parent-Adolescent Relationships

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ClinicalTrials.gov Identifier: NCT04780620
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Madison Aitken, Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Depression Other: Parent Intervention Group Not Applicable

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 part of the care pathway for youth depression 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 and adolescents will complete a combination of questionnaire, interview, and observationally coded measures at pre- and posttreatment, along with questionnaire measures at mid-treatment and 3 months follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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).
Primary Purpose: Supportive Care
Official Title: Addressing Parent-Adolescent Relationship Issues in the Treatment of Adolescent Depression: A Pilot Study
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parent Intervention Group
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.
Other: Parent Intervention Group
Parents will be involved in 8 weekly sessions.

No Intervention: Usual Care Group
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Parent Expressed Emotion [ Time Frame: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up ]
    Parent report on the Family Questionnaire; Adolescent report on the Level of Expressed Emotion questionnaire; Observational coding of parent Five Minute Speech Sample

  2. Parent Affective Responding [ Time Frame: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up ]
    Parent and adolescent report on the Coping with Children's Negative Emotions Scale and the Responding to Adolescents' Happy Affect Scale

  3. Parent-Adolescent Conflict [ Time Frame: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up ]
    Parent and adolescent report on the Issues Checklist

  4. Parent-Adolescent Interaction [ Time Frame: Pre- & post-treatment (8 weeks) ]
    Observational coding of parent-adolescent discussion of a topic of conflict (drawn from the Issues Checklist), coded using the System for Coding Interactions in Family Functioning

  5. Adolescent depression [ Time Frame: Pre-, mid- (4 weeks), and post-treatment (8 weeks), and at 3-month follow-up ]
    Adolescent self-report on the Mood and Feelings Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780620


Contacts
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Contact: Madison Aitken, Ph.D. 416-535-8501 ext 34091 madison.aitken@camh.ca

Locations
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Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4
Contact: Madison Aitken, Ph.D.    416-535-8501 ext 34091    madison.aitken@camh.ca   
Contact: Yola El Dahr, M.Sc.       yola.eldahr@camh.ca   
Principal Investigator: Madison Aitken, Ph.D.         
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Madison Aitken, Ph.D. Centre for Addiction and Mental Health
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Responsible Party: Madison Aitken, Clinician Investigator at Cundill Centre for Child and Youth Depression; Psychologist in the Child, Youth and Emerging Adult Program, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT04780620    
Other Study ID Numbers: 098-2020
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing IPD has not currently been approved by our Research Ethics Board and would also require a data sharing agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Madison Aitken, Centre for Addiction and Mental Health:
youth depression
adolescent depression
psychosocial intervention
parent-adolescent conflict
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders