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Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties

Primary Purpose

Anxiety, Depression, Behavior Problem

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Emotion Focused Family Therapy

About this trial

This is an interventional treatment trial for Anxiety focused on measuring children, parents, mental health, emotion, psychotherapy, parent-child relationship

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Parent of child aged 7 to 15 years old with anxiety, depression, or behavioural challenges Parent of child is willing to participate in intervention Parent is living at home with the child Exclusion Criteria: Parent or child not proficient enough in speaking/understanding English to complete measures or EFFT intervention components Parent or child with a severe mental health disorder (e.g., active suicidality and psychosis) is not considered suitable for the trial intervention due to the clinical need for immediate intervention Parent or child is actively receiving, or due to receive, intensive psychological intervention focused on cognitive and/or behavioural strategies to intervene with emotional or behavioural difficulties Parent or child has any disabilities in language, speech or hearing that would interfere with their completion of the EFFT and measures Parent or child are allergic to adhesive electrode gel use in some tasks (i.e., sodium chloride)

Sites / Locations

Maplewoods Centre for Family Therapy and Child Psychology, University of GuelphRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Waitlist

EFFT intervention

Arm Description

No treatment will be administered to participants in this arm until after the post-treatment in-lab assessment is completed.

Treatment (Emotion Focused Family Therapy) will be administered to participants in this arm.

Outcomes

Primary Outcome Measures

Change in parental psychopathology symptoms at 6 weeks and 4 months

This outcome will be measured through the Kessler Psychological Distress Scale (K10), a 10-item self report measure of psychological symptoms that parents will complete. Parents will rate the extent to which they are affected by various psychopathology symptoms on a five-point Likert scale from 1 (None of the time) to 5 (All of the time), with greater total scores (range = 10-50) indicating more severe psychopathology.

Change in child psychopathology symptoms at 6 weeks and 4 months

This outcome will be measured through the Behavior and Feelings Survey (BFS), a 12-item measure of child psychopathology symptoms to be completed by both parents (parent-report) and children (youth-report). Parents and children will rate items on a five-point Likert scale from 0 (Not a problem) to 4 (A very big problem), with greater scores (Internalizing subscale range = 0-24; Externalizing subscale range = 0-24; Total score range = 0-48) indicating more severe psychopathology.

Change in parental emotion regulation at 6 weeks and 4 months

This outcome will be measured through the Difficulties in Emotion Regulation Scale (DERS), a 36-item self-report measure of emotion regulation difficulties to be completed by parents. Parents will indicate the frequency with which they experience difficulties with emotion regulation on a five-point Likert scale from 1 (Almost never) to 5 (Almost always), with greater total scores (range = 36-180) indicating greater difficulties with emotion regulation.

Change in child emotion regulation at 6 weeks and 4 months

This outcome will be measured through the Negative Emotionality subscale of the Child and Adolescent Dispositions Scale (CADS), a scale of child emotion regulation to be completed by parents (parent-report) and children (youth-report). Parents and children will rate the seven Negative Emotionality items on a four-point Likert scale from 1 (Not at all) to 4 (Very much/very often) with greater scores (range = 7-28) indicating poorer emotion regulation.

Change in parent-child co-regulation at 6 weeks and 4 months

This outcome will be measured by parent-child synchrony of heart rate variability during the completion of two lab tasks together (conflict discussion and puzzle task).

Change in parent-child relationship functioning at 6 weeks and 4 months

This outcome will be measured by having parents and their children participate in two lab tasks together (conflict discussion and puzzle task) and coding for behavioural observations.

Secondary Outcome Measures

Change in parental emotion socialization at 6 weeks and 4 months

This outcome will be measured through the Coping with Children's Negative Emotions Scale (CCNES), a 12-item self-report measure of parental emotion parenting practices in response to children's expression of negative emotion. Responses are divided into six subscales representing six distinct types of parental responses. The responses will be grouped in two overall scores: Supportive (Expressive Encouragement, Problem-Focused, and Emotion-Focused Reactions) and Unsupportive (Punitive, Minimizing, and Distress Reactions) practices. Parents will rate the likelihood that they would respond in these distinct ways on a seven-point Likert scale from 1 (Very unlikely) to 7 (Very likely), with greater overall scores (range = 1-7) indicating greater levels of each type of parental response.

Change in parental emotion blocks at 6 weeks and 4 months

This outcome will be measured through the Caregiver Traps Scale (CTS), a 14-item self-report measure of parental emotional blocks. Parents will rate each item on a seven-point Likert scale ranging from 1 (Not likely) to 7 (Extremely Likely), with higher total scores (range = 14-98) indicating greater levels of parental emotional blocks.

Change in parental self-efficacy at 6 weeks and 4 months

This outcome will be measured through the Me as a Parent Questionnaire (MaaP), a 16-item self-report measure of parental self-efficacy. Parents will rate the degree to which they agree with statements about their feelings of competence in their parent role on a five-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree), with greater total scores (range = 16-80) indicating greater parental self-efficacy.

Fidelity of EFFT program

This outcome will be measured via audiorecording of group sessions. Fidelity scores will be calculated based on content fidelity - i.e., The degree to which providers implemented the key EFFT components, including: behaviour coaching, emotion coaching, parental emotion blocks, therapeutic apology.

Change in perceived parental stress at 6 weeks and 4 months

Parents' perceived level of stress related to tasks associated with parenting will be assessed via the Parental Stress Scale. The Parental Stress Scale is an 18-item parent-report measure that assesses perceived parental stress (sample item: "Caring for my child(ren) sometimes takes more time and energy than I have to give") while taking into account positive and negative facets of parenting. The three subscales that comprise the measure (positive emotional benefits of parenting, sense of enrichment and personal fulfillment, and negative components of parenting) can be summed to form a composite score. Items are rated on a five-point Likert scale from 1 (Strongly Disagree) to 4 (Strongly Agree) with lower scores (range = 18-90) indicating lower levels of parenting stress.

Parental treatment satisfaction

Parental treatment satisfaction will be assessed using the parent-report of the Parent/Child Satisfaction Scales, a parent-report measure of satisfaction with child-oriented mental health services. The parent-report measure (sample item: "To what extent has our program met your child's needs?") has shown good internal consistency and test-retest reliability in prior samples of parents of clinic-referred children. Items are rated on a four-point Likert scale from 1 (Quite dissatisfied) to 4 (Very satisfied), with greater total scores (range = 8-32) indicative of higher overall treatment satisfaction.

Parent-reported change in familial functioning at 6 weeks and 4 months

Parent report of familial functioning will be assessed via the McMaster Family Assessment Device, a 60-item measure of broad family functioning that can be completed by any measure of the family system. The measure has subscales that assess particular facets of family functioning (e.g., affective responsiveness; "we cry openly"), which can be summed to form a composite score. Items are rated on a four-point Likert scale from 1 (Strongly Agree) to 4 (Strongly Disagree). Item responses are summed and divided by the number of items in the measure to compute a total score (range = 1-4), with lower total scores indicating more adaptive family functioning.

Change in physiological arousal at 6 weeks and 4 months

This outcome will be measured by parent and child skin conductance levels during the completion of two lab tasks together (conflict discussion and puzzle task).

Full Information

NCT ID

NCT05603000

First Posted

October 13, 2022

Last Updated

October 27, 2022

Sponsor

University of Guelph

1. Study Identification

Unique Protocol Identification Number

NCT05603000

Brief Title

Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties

Official Title

A Randomized Controlled Trial of Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 11, 2022 (Actual)

Primary Completion Date

August 2026 (Anticipated)

Study Completion Date

August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Guelph

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Emotion Focused Family Therapy (EFFT) is a promising intervention that aims to teach parents advanced skills to support their child's development of emotion skills and increase their adaptive behaviours, potentially leading to improvements in their child's psychological functioning and family functioning more broadly. This randomized controlled trial (RCT; EFFT vs waitlist control) will (1) test the efficacy of a 6-week group EFFT program on parent and child outcomes and (2) examine maintenance of treatment gains up to four months post-intervention.

Detailed Description

This randomized controlled trial (RCT) will test the efficacy of a 6-week Emotion Focused Family Therapy (EFFT) group program on parent and child outcomes, compared to a waitlist control. Families will be randomized to either the EFFT group treatment or a waitlist. The RCT will evaluate changes in parent functioning, child functioning, and parent-child relationship functioning. A 4-month follow-up will test whether any changes from pre-to-post intervention are maintained at 4 months. The RCT will also test proposed mechanisms of change (parent-child relationship quality, family functioning) and moderators of treatment effectiveness (parental stress).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Depression, Behavior Problem

Keywords

children, parents, mental health, emotion, psychotherapy, parent-child relationship

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This study is a randomized controlled trial, consisting of an intervention arm (EFFT) and a waitlist control arm, which will occur concurrently.

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Waitlist

Arm Type

No Intervention

Arm Description

No treatment will be administered to participants in this arm until after the post-treatment in-lab assessment is completed.

Arm Title

EFFT intervention

Arm Type

Experimental

Arm Description

Treatment (Emotion Focused Family Therapy) will be administered to participants in this arm.

Intervention Type

Behavioral

Intervention Name(s)

Emotion Focused Family Therapy

Other Intervention Name(s)

EFFT

Intervention Description

The Emotion Focused Family Therapy (EFFT) intervention for this study will be delivered to groups of four to ten parents over six weekly sessions of two hours each. The goal of EFFT is to teach and empower parents to coach their child to process the emotions at the source of their mental health symptoms, to increase their child's adaptive behaviours, and to repair emotional injuries within the parent-child relationship. EFFT also targets parents' own emotional challenges that may prevent them from feeling capable or being able to support their child's treatment. Each EFFT session will include introductions, psychoeducation about emotion and psychopathology, introduction of skills, experiential activities (e.g., chair work), open discussion and feedback, and homework activities covering the foci of EFFT: emotion coaching, behaviour coaching, therapeutic apology, and parental emotion blocks.

Primary Outcome Measure Information:

Title

Change in parental psychopathology symptoms at 6 weeks and 4 months

Description

Time Frame

Change at 6 weeks; Change at 4 months

Title

Change in child psychopathology symptoms at 6 weeks and 4 months

Description

Time Frame

Change at 6 weeks; Change at 4 months

Title

Change in parental emotion regulation at 6 weeks and 4 months

Description

Time Frame

Change at 6 weeks; Change at 4 months

Title

Change in child emotion regulation at 6 weeks and 4 months

Description

Time Frame

Change at 6 weeks; Change at 4 months

Title

Change in parent-child co-regulation at 6 weeks and 4 months

Description

This outcome will be measured by parent-child synchrony of heart rate variability during the completion of two lab tasks together (conflict discussion and puzzle task).

Time Frame

Change at 6 weeks; Change at 4 months

Title

Change in parent-child relationship functioning at 6 weeks and 4 months

Description

This outcome will be measured by having parents and their children participate in two lab tasks together (conflict discussion and puzzle task) and coding for behavioural observations.

Time Frame

Change at 6 weeks; Change at 4 months

Secondary Outcome Measure Information:

Title

Change in parental emotion socialization at 6 weeks and 4 months

Description

Time Frame

Change at 6 weeks; Change at 4 months

Title

Change in parental emotion blocks at 6 weeks and 4 months

Description

Time Frame

Change at 6 weeks; Change at 4 months

Title

Change in parental self-efficacy at 6 weeks and 4 months

Description

Time Frame

Change at 6 weeks; Change at 4 months

Title

Fidelity of EFFT program

Description

Time Frame

Throughout intervention over 6 weeks

Title

Change in perceived parental stress at 6 weeks and 4 months

Description

Time Frame

Change at 6 weeks; Change at 4 months

Title

Parental treatment satisfaction

Description

Time Frame

At 6 weeks

Title

Parent-reported change in familial functioning at 6 weeks and 4 months

Description

Time Frame

Change at 6 weeks; Change at 4 months

Title

Change in physiological arousal at 6 weeks and 4 months

Description

This outcome will be measured by parent and child skin conductance levels during the completion of two lab tasks together (conflict discussion and puzzle task).

Time Frame

Change at 6 weeks; Change at 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kristel Thomassin, Ph.D

Phone

519-824-4120

Ext

3016

kristel.thomassin@uoguelph.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Jessica A Seddon, MSc

jseddon@uoguelph.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristel Thomassin, Ph.D

Organizational Affiliation

University of Guelph

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maplewoods Centre for Family Therapy and Child Psychology, University of Guelph

City

Guelph

State/Province

Ontario

ZIP/Postal Code

N1G 4S7

Country

Canada

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties

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