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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05603000
• Other study ID #: EFFT
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: August 2026

Study information

• Verified date: March 2024
• Source: University of Guelph
• Contact: Kristel Thomassin, Ph.D
• Phone: 519-824-4120
• Email: kristel.thomassin[@]uoguelph.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Behavior Problem
• Depression
• Problem Behavior

Intervention

Behavioral:
• Emotion Focused Family Therapy
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.

Locations

Country	Name	City	State
Canada	Maplewoods Centre for Family Therapy and Child Psychology, University of Guelph	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Guelph

Country where clinical trial is conducted

Canada, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 at 6 weeks; Change at 4 months
Primary	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 at 6 weeks; Change at 4 months
Primary	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 at 6 weeks; Change at 4 months
Primary	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 at 6 weeks; Change at 4 months
Primary	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 at 6 weeks; Change at 4 months
Primary	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.	Change at 6 weeks; Change at 4 months
Secondary	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 at 6 weeks; Change at 4 months
Secondary	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 at 6 weeks; Change at 4 months
Secondary	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.	Change at 6 weeks; Change at 4 months
Secondary	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.	Throughout intervention over 6 weeks
Secondary	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.	Change at 6 weeks; Change at 4 months
Secondary	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.	At 6 weeks
Secondary	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 at 6 weeks; Change at 4 months
Secondary	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).	Change at 6 weeks; Change at 4 months