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Pilot Study of the Parental Friendship Coaching+ Program for Families of Children With Attention-deficit/Hyperactivity Disorder (PFC+)

Primary Purpose

ADHD, Depression

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PFC+
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring parent training, ADHD, friendship, mental health

Eligibility Criteria

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

Inclusion Criteria:

Parents who participate in this study must meet the following criteria:

  1. have a child (age 6-11) with elevated ADHD symptoms and peer difficulties;
  2. have at minimum subclinical levels of depression and/or ADHD determined by self-report on symptom measures (parents with clinical levels are eligible);
  3. be the primary parent involved with the child and their social life.

Exclusion Criteria:

Parents will be excluded if:

  1. they cannot understand or speak English at a 9th grade level as they will be unable to participate in PFC+ (delivered in English) or complete questionnaires (reading/writing at the 9th grade level is not required as parents can be provided support in reading questionnaires and PFC+ content is delivered verbally);
  2. they require alternative supports for more pressing mental health concerns (such that it would not be in their best interest to delay those other supports in order to participate in the current study), this might include schizophrenia, psychosis, a personality disorder, autism, intellectual disability, suicidal ideation, or self harm (they will be referred to alternative supports as needed);
  3. they are participating in a different BPT program at the same time as they are projected to participate in PFC+;
  4. if their 6-11 year old child has autism, pervasive developmental disorder, diagnosed or suspected intellectual disability, psychosis, or active suicidality (they will be referred to alternative supports as needed);
  5. if their child does understand or speak English at the 1st grade level, as they will need to complete some questionnaires (research assistants will support children through questionnaires so reading at a 1st grade level is not required);
  6. they do not have access to a computer, internet, and a private space to attend sessions (as the sessions are online, and a private space is needed to protect the confidentiality of other study participants).

Sites / Locations

  • University of British Columbia, Department of PsychologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PFC+

Waitlist

Arm Description

In this condition, therapists instruct parents in ways to coach their children to display better friendship behaviours using skill teaching and home practice. The program includes 2 intake sessions, a group workshop where all strategies are reviewed, and 3 consultation sessions to work on implementing strategies with therapist support.

In this condition, parents are placed on a waitlist where they continue life as usual. After the waitlist they participate in the PFC+ program.

Outcomes

Primary Outcome Measures

Attendance (how many sessions did they attend)
- Descriptor: how many sessions did parents attend? This will be recorded after each session, and there are 6 possible sessions
Homework completion
- Descriptor: how often did parents complete their homework goals? Measured by the number of homework assignments that parents competed, out of four possible homework assignments
Time spent on material
- Descriptor: how many minutes did parents spend on program material outside of sessions. Measured by the total amount of minutes that parents spent on program material outside of session, over the entire program.
Early Working Alliance with Therapist (Working Alliance Inventory)
- Descriptor: Therapeutic alliance
Post-Treatment Working Alliance with Therapist (Working Alliance Inventory)
- Descriptor: Therapeutic Alliance
Group Social Support (Revised Working Alliance Inventory - Bond subscale)
- Descriptor: Modified (WAI-SR) to report on bond between group members
Treatment Satisfaction
- Descriptor: how much did parents enjoy each session. Calculated as the average satisfaction with treatment, calculated as the mean of parent ratings of satisfaction obtained after each session.
Change in Parenting Behaviour After Program (Alabama Parenting Questionnaire)
- Descriptor: Change in use of positive/negative parenting behaviours
Change in Parenting Behaviour at Follow-Up (Alabama Parenting Questionnaire)
- Descriptor: Change in use of positive/negative parenting behaviours
Change in Parent Friendship Facilitation After Program (Friendship Facilitation Questionnaire)
- Descriptor: Change in use of friendship facilitation skills
Change in Parent Friendship Facilitation at Follow-Up (Friendship Facilitation Questionnaire)
- Descriptor: Change in use of friendship facilitation skills
Change in Parenting Stress After program (Parenting Stress Index - Short Form)
- Descriptor: Change in parent stress levels
Change in Parenting Stress at Follow-Up (Parenting Stress Index - Short Form)
- Descriptor: Change in parent stress levels
Change in Parenting Competence After Program (Parenting Sense of Competence Questionnaire)
- Descriptor: Change in parent-reported levels of parenting competence
Change in Parenting Competence at Follow-Up (Parenting Sense of Competence Questionnaire)
- Descriptor: Change in parent-reported levels of parenting competence

Secondary Outcome Measures

Change in Child Peer Problems After Program (Strengths and Difficulties Questionnaire - Peer Problems Subscale)
- Descriptor: Change in parent-reported child peer problems
Change in Child Peer Problems at Follow-Up (Strengths and Difficulties Questionnaire - Peer Problems Subscale)
- Descriptor: Change in parent-reported child peer problems
Change in Child Quality of Play After Program (Quality of Play Questionnaire)
- Descriptor: Change in parent-reported child quality of play
Change in Child Quality of Play at Follow Up (Quality of Play Questionnaire)
- Descriptor: Change in parent-reported child quality of play

Full Information

First Posted
February 16, 2022
Last Updated
April 13, 2022
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05333887
Brief Title
Pilot Study of the Parental Friendship Coaching+ Program for Families of Children With Attention-deficit/Hyperactivity Disorder
Acronym
PFC+
Official Title
Moderators and Mediators of Behavioural Parent Training Outcomes for Children With Attention-deficit/Hyperactivity Disorder: Evaluating the Importance of Addressing Parent Psychopathology and Treatment Process Factors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)

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
Behavioural parent training (BPT) is a front-line treatment for children with attention-deficit/hyperactivity disorder (ADHD) that teaches parents how to support their child and manage behaviour. Parents of children with ADHD who have their own elevated ADHD/depressive symptoms may be less likely connect/engage and benefit from BPT. The current study modifies a BPT program that specifically addresses peer difficulties as these are common in children with ADHD. The goal of the modifications is to enhance the treatment process (how much parents connect and engage with the treatment) for parents with elevated ADHD/depressive symptoms. The Investigators will test whether this intervention increases parent engagement/connection to the program and whether it improves parenting behaviour.
Detailed Description
Study Purpose: The aim of this study is to conduct a pilot of PFC+ (a modified version of Parental Friendship Coaching), a BPT program for parents of children with ADHD and peer difficulties. Dr. Mikami created PFC and has conducted a randomized controlled trial comparing PFC to a psychoeducation/social support group. The investigators have modified PFC for parents with elevated ADHD and/or depressive symptoms to encourage engagement and connection with the program with the goal of improving eventual outcomes for these families. The reason why this modification was done is because parents with elevated ADHD and/or depressive symptoms typically do not benefit from BPT as much as parents without elevated symptoms. The current study examines the potential benefit of such modifications for these populations. Hypothesis: The first hypothesis is that parents who participate in PFC+ will engage well with the program (attend, complete homework) and will report feeling connected to the program (satisfied with treatment, alliance with therapist, social support from parent peers). The second hypothesis is that participation in PFC+ will be associated with improvement in parenting related outcomes (parenting behaviour, parent stress, parent sense of competence), both over time and relative to a waitlist control condition. Study Population: Participants will be families of children between the ages of 6-11. The parent will have elevated ADHD or depressive symptoms and will participate in the treatment and complete questionnaires and interviews. Children will have elevated ADHD symptoms and peer difficulties, and will complete questionnaires about the parent's parenting style. A co-parent will also be recruited, and can be anyone who can provide another perspective on the parent's parenting style (e.g., romantic partner, grandparent of the child); co-parents will complete questionnaires about the parent's parenting style. Research Method: The investigators will recruit 48 parents to participate in the pilot of PFC+ and will use a crossover design so that all parents have the opportunity to participate in PFC+. In the eligibility screening, the parent will complete questionnaires about their symptoms and their child's symptoms to determine eligibility. At timepoint 1 (T1), all eligible families (parent, child, co-parent) will complete initial questionnaires to collect data about baseline functioning. Parents will be randomized to participate in PFC+ or a waitlist control condition (6 parents in each condition). PFC+ parents will then complete the treatment program over 5-6 weeks, while the waitlist parents will continue life as usual for 5-6 weeks. After PFC+ completes, all families will complete timepoint 2 (T2) questionnaires. Following this, crossover will occur, where parents in PFC+ will enter a naturalistic follow up, and parents previously in the waitlist condition will begin PFC+. Once treatment has finished (another 5-6 weeks), all families will complete timepoint 3 (T3) questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Depression
Keywords
parent training, ADHD, friendship, mental health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study attempts to modify a BPT program to be better suited to the needs of parents with mental health concerns. Modifications include ways to improve parent engagement and connection to the program. Parent engagement is often addressed by reducing practical barriers. All sessions are provided online, all strategies are presenting in a half-day group workshop, the remaining sessions only occur with 1-2 parents and are flexibly scheduled for the parent, a treatment menu is used to support easy tailoring of homework to family needs, and a general flexible approach is used. Programs also target parent connection via modifications to improve cognitions about treatment and ADHD, increase alliance, or increase treatment satisfaction. In the first two sessions barriers to treatment and unhelpful thoughts about treatment are discussed, the workshop is a group format, parents have the option to be put in pairs for social support, and they have a consistent therapist throughout the program.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PFC+
Arm Type
Experimental
Arm Description
In this condition, therapists instruct parents in ways to coach their children to display better friendship behaviours using skill teaching and home practice. The program includes 2 intake sessions, a group workshop where all strategies are reviewed, and 3 consultation sessions to work on implementing strategies with therapist support.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
In this condition, parents are placed on a waitlist where they continue life as usual. After the waitlist they participate in the PFC+ program.
Intervention Type
Behavioral
Intervention Name(s)
PFC+
Intervention Description
Therapists instruct parents in ways to coach their children to display better friendship behaviours using skill teaching and home practice. The program includes 2 intake sessions, a group workshop where all strategies are reviewed, and 3 consultation sessions to work on implementing strategies with therapist support. Emphasis throughout the program is placed on parents' connection and engagement with the material and therapist.
Primary Outcome Measure Information:
Title
Attendance (how many sessions did they attend)
Description
- Descriptor: how many sessions did parents attend? This will be recorded after each session, and there are 6 possible sessions
Time Frame
The six possible sessions of the program in total, which occur over approximately 7 weeks
Title
Homework completion
Description
- Descriptor: how often did parents complete their homework goals? Measured by the number of homework assignments that parents competed, out of four possible homework assignments
Time Frame
The four possible sessions where homework is assigned, which occur over 4 weeks covering the last 4 sessions of the program
Title
Time spent on material
Description
- Descriptor: how many minutes did parents spend on program material outside of sessions. Measured by the total amount of minutes that parents spent on program material outside of session, over the entire program.
Time Frame
The four possible sessions where homework is assigned, which occur over 4 weeks covering the last 4 sessions of the program
Title
Early Working Alliance with Therapist (Working Alliance Inventory)
Description
- Descriptor: Therapeutic alliance
Time Frame
Measured in week 2 of the program (after session 2)
Title
Post-Treatment Working Alliance with Therapist (Working Alliance Inventory)
Description
- Descriptor: Therapeutic Alliance
Time Frame
Measured in week 7 (approximately one week after program completion)
Title
Group Social Support (Revised Working Alliance Inventory - Bond subscale)
Description
- Descriptor: Modified (WAI-SR) to report on bond between group members
Time Frame
Measured in week 7 (approximately one week after program completion)
Title
Treatment Satisfaction
Description
- Descriptor: how much did parents enjoy each session. Calculated as the average satisfaction with treatment, calculated as the mean of parent ratings of satisfaction obtained after each session.
Time Frame
The six possible sessions of the program in total, which occur over approximately 7 weeks
Title
Change in Parenting Behaviour After Program (Alabama Parenting Questionnaire)
Description
- Descriptor: Change in use of positive/negative parenting behaviours
Time Frame
From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
Title
Change in Parenting Behaviour at Follow-Up (Alabama Parenting Questionnaire)
Description
- Descriptor: Change in use of positive/negative parenting behaviours
Time Frame
From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
Title
Change in Parent Friendship Facilitation After Program (Friendship Facilitation Questionnaire)
Description
- Descriptor: Change in use of friendship facilitation skills
Time Frame
From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
Title
Change in Parent Friendship Facilitation at Follow-Up (Friendship Facilitation Questionnaire)
Description
- Descriptor: Change in use of friendship facilitation skills
Time Frame
From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
Title
Change in Parenting Stress After program (Parenting Stress Index - Short Form)
Description
- Descriptor: Change in parent stress levels
Time Frame
From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
Title
Change in Parenting Stress at Follow-Up (Parenting Stress Index - Short Form)
Description
- Descriptor: Change in parent stress levels
Time Frame
From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
Title
Change in Parenting Competence After Program (Parenting Sense of Competence Questionnaire)
Description
- Descriptor: Change in parent-reported levels of parenting competence
Time Frame
From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
Title
Change in Parenting Competence at Follow-Up (Parenting Sense of Competence Questionnaire)
Description
- Descriptor: Change in parent-reported levels of parenting competence
Time Frame
From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
Secondary Outcome Measure Information:
Title
Change in Child Peer Problems After Program (Strengths and Difficulties Questionnaire - Peer Problems Subscale)
Description
- Descriptor: Change in parent-reported child peer problems
Time Frame
From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
Title
Change in Child Peer Problems at Follow-Up (Strengths and Difficulties Questionnaire - Peer Problems Subscale)
Description
- Descriptor: Change in parent-reported child peer problems
Time Frame
From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
Title
Change in Child Quality of Play After Program (Quality of Play Questionnaire)
Description
- Descriptor: Change in parent-reported child quality of play
Time Frame
From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
Title
Change in Child Quality of Play at Follow Up (Quality of Play Questionnaire)
Description
- Descriptor: Change in parent-reported child quality of play
Time Frame
From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parents who participate in this study must meet the following criteria: have a child (age 6-11) with elevated ADHD symptoms and peer difficulties; have at minimum subclinical levels of depression and/or ADHD determined by self-report on symptom measures (parents with clinical levels are eligible); be the primary parent involved with the child and their social life. Exclusion Criteria: Parents will be excluded if: they cannot understand or speak English at a 9th grade level as they will be unable to participate in PFC+ (delivered in English) or complete questionnaires (reading/writing at the 9th grade level is not required as parents can be provided support in reading questionnaires and PFC+ content is delivered verbally); they require alternative supports for more pressing mental health concerns (such that it would not be in their best interest to delay those other supports in order to participate in the current study), this might include schizophrenia, psychosis, a personality disorder, autism, intellectual disability, suicidal ideation, or self harm (they will be referred to alternative supports as needed); they are participating in a different BPT program at the same time as they are projected to participate in PFC+; if their 6-11 year old child has autism, pervasive developmental disorder, diagnosed or suspected intellectual disability, psychosis, or active suicidality (they will be referred to alternative supports as needed); if their child does understand or speak English at the 1st grade level, as they will need to complete some questionnaires (research assistants will support children through questionnaires so reading at a 1st grade level is not required); they do not have access to a computer, internet, and a private space to attend sessions (as the sessions are online, and a private space is needed to protect the confidentiality of other study participants).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Smit, MA
Phone
604-822-8756
Email
sophiesmit@psych.ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Amori Mikami, PhD
Phone
6048223245
Email
mikami@psych.ubc.ca
Facility Information:
Facility Name
University of British Columbia, Department of Psychology
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Smit, MA
Phone
604-822-8756
Email
sophiesmit@psych.ubc.ca
First Name & Middle Initial & Last Name & Degree
Amori Y Mikami, PhD
Phone
604-822-3245
Email
mikami@psych.ubc.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In line with current best practices of psychological research, electronic de-identified data may be uploaded to a research repository or open science initiative for transparency and for possible future use. Any data shared through these initiatives will be uploaded in the form of a computer software file (e.g., SPSS) without any identifying information.
IPD Sharing Time Frame
After the main manuscript from the study is accepted, for 5 years.
IPD Sharing Access Criteria
Investigator with doctoral degree in psychology or related field, or student being supervised by such an investigator.

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Pilot Study of the Parental Friendship Coaching+ Program for Families of Children With Attention-deficit/Hyperactivity Disorder

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