- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05333887
Pilot Study of the Parental Friendship Coaching+ Program for Families of Children With Attention-deficit/Hyperactivity Disorder (PFC+)
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 Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sophie Smit, MA
- Phone Number: 604-822-8756
- Email: sophiesmit@psych.ubc.ca
Study Contact Backup
- Name: Amori Mikami, PhD
- Phone Number: 6048223245
- Email: mikami@psych.ubc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 1Z4
- Recruiting
- University of British Columbia, Department of Psychology
-
Contact:
- Sophie Smit, MA
- Phone Number: 604-822-8756
- Email: sophiesmit@psych.ubc.ca
-
Contact:
- Amori Y Mikami, PhD
- Phone Number: 604-822-3245
- Email: mikami@psych.ubc.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PFC+
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.
|
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.
|
No Intervention: Waitlist
In this condition, parents are placed on a waitlist where they continue life as usual.
After the waitlist they participate in the PFC+ program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attendance (how many sessions did they attend)
Time Frame: The six possible sessions of the program in total, which occur over approximately 7 weeks
|
- Descriptor: how many sessions did parents attend?
This will be recorded after each session, and there are 6 possible sessions
|
The six possible sessions of the program in total, which occur over approximately 7 weeks
|
Homework completion
Time Frame: The four possible sessions where homework is assigned, which occur over 4 weeks covering the last 4 sessions of the program
|
- 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
|
The four possible sessions where homework is assigned, which occur over 4 weeks covering the last 4 sessions of the program
|
Time spent on material
Time Frame: The four possible sessions where homework is assigned, which occur over 4 weeks covering the last 4 sessions of the program
|
- 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.
|
The four possible sessions where homework is assigned, which occur over 4 weeks covering the last 4 sessions of the program
|
Early Working Alliance with Therapist (Working Alliance Inventory)
Time Frame: Measured in week 2 of the program (after session 2)
|
- Descriptor: Therapeutic alliance
|
Measured in week 2 of the program (after session 2)
|
Post-Treatment Working Alliance with Therapist (Working Alliance Inventory)
Time Frame: Measured in week 7 (approximately one week after program completion)
|
- Descriptor: Therapeutic Alliance
|
Measured in week 7 (approximately one week after program completion)
|
Group Social Support (Revised Working Alliance Inventory - Bond subscale)
Time Frame: Measured in week 7 (approximately one week after program completion)
|
- Descriptor: Modified (WAI-SR) to report on bond between group members
|
Measured in week 7 (approximately one week after program completion)
|
Treatment Satisfaction
Time Frame: The six possible sessions of the program in total, which occur over approximately 7 weeks
|
- 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.
|
The six possible sessions of the program in total, which occur over approximately 7 weeks
|
Change in Parenting Behaviour After Program (Alabama Parenting Questionnaire)
Time Frame: From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
|
- Descriptor: Change in use of positive/negative parenting behaviours
|
From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
|
Change in Parenting Behaviour at Follow-Up (Alabama Parenting Questionnaire)
Time Frame: From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
|
- Descriptor: Change in use of positive/negative parenting behaviours
|
From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
|
Change in Parent Friendship Facilitation After Program (Friendship Facilitation Questionnaire)
Time Frame: From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
|
- Descriptor: Change in use of friendship facilitation skills
|
From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
|
Change in Parent Friendship Facilitation at Follow-Up (Friendship Facilitation Questionnaire)
Time Frame: From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
|
- Descriptor: Change in use of friendship facilitation skills
|
From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
|
Change in Parenting Stress After program (Parenting Stress Index - Short Form)
Time Frame: From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
|
- Descriptor: Change in parent stress levels
|
From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
|
Change in Parenting Stress at Follow-Up (Parenting Stress Index - Short Form)
Time Frame: From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
|
- Descriptor: Change in parent stress levels
|
From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
|
Change in Parenting Competence After Program (Parenting Sense of Competence Questionnaire)
Time Frame: From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
|
- Descriptor: Change in parent-reported levels of parenting competence
|
From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
|
Change in Parenting Competence at Follow-Up (Parenting Sense of Competence Questionnaire)
Time Frame: From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
|
- Descriptor: Change in parent-reported levels of parenting competence
|
From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Child Peer Problems After Program (Strengths and Difficulties Questionnaire - Peer Problems Subscale)
Time Frame: From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
|
- Descriptor: Change in parent-reported child peer problems
|
From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
|
Change in Child Peer Problems at Follow-Up (Strengths and Difficulties Questionnaire - Peer Problems Subscale)
Time Frame: From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
|
- Descriptor: Change in parent-reported child peer problems
|
From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
|
Change in Child Quality of Play After Program (Quality of Play Questionnaire)
Time Frame: From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
|
- Descriptor: Change in parent-reported child quality of play
|
From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
|
Change in Child Quality of Play at Follow Up (Quality of Play Questionnaire)
Time Frame: From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
|
- Descriptor: Change in parent-reported child quality of play
|
From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H21-00930
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Lawson Health Research InstituteTerminated
Clinical Trials on PFC+
-
Boston Children's HospitalPatient-Centered Outcomes Research Institute; Pediatric Research in Inpatient...Not yet recruitingCommunicationUnited States
-
DePuy InternationalTerminated
-
DePuy InternationalTerminatedOsteoarthritis, KneeUnited Kingdom
-
Maidstone & Tunbridge Wells NHS TrustActive, not recruitingOsteoarthritis, KneeUnited Kingdom
-
Ewha Womans UniversityCompletedOsteoarthritisKorea, Republic of
-
Coxa, Hospital for Joint ReplacementUnknownOsteoarthritis, Knee | Arthroplasty | Total Knee ReplacementFinland
-
DePuy InternationalCompletedKnee OsteoarthritisUnited Kingdom
-
DePuy InternationalCompleted
-
University of Texas Southwestern Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Andrew Moses Lee, MD, PhDRecruitingObsessive-Compulsive DisorderUnited States