ADHDPFC+NCT05333887
Pilot Study of the Parental Friendship Coaching+ Program for Families of Children With Attention-deficit/Hyperactivity Disorder
A study testing PFC+ in people with ADHD and Depression, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- ADHD, Depression
- What is being tested?
- PFC+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 10 Dec 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Department of Psychology
Vancouver, British Columbia, V6T 1Z4
About this study
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
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.
Read the 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.
- Conditions
- ADHD, Depression
- Being tested
- PFC+
- Keywords
- parent training, ADHD, friendship, mental health
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFC+Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PFC+ | Experimental | 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. Receives: Behavioral: PFC+ |
| Waitlist | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The six possible sessions of the program in total, which occur over approximately 7 weeks
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
Measured: 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
- 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.
Measured: 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)
- Descriptor: Therapeutic alliance
Measured: Measured in week 2 of the program (after session 2)
Post-Treatment Working Alliance with Therapist (Working Alliance Inventory)
- Descriptor: Therapeutic Alliance
Measured: Measured in week 7 (approximately one week after program completion)
Group Social Support (Revised Working Alliance Inventory - Bond subscale)
- Descriptor: Modified (WAI-SR) to report on bond between group members
Measured: Measured in week 7 (approximately one week after program completion)
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.
Measured: The six possible sessions of the program in total, which occur over approximately 7 weeks
Change in Parenting Behaviour After Program (Alabama Parenting Questionnaire)
- Descriptor: Change in use of positive/negative parenting behaviours
Measured: 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)
- Descriptor: Change in use of positive/negative parenting behaviours
Measured: 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)
- Descriptor: Change in use of friendship facilitation skills
Measured: 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)
- Descriptor: Change in use of friendship facilitation skills
Measured: 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)
- Descriptor: Change in parent stress levels
Measured: 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)
- Descriptor: Change in parent stress levels
Measured: 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)
- Descriptor: Change in parent-reported levels of parenting competence
Measured: 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)
- Descriptor: Change in parent-reported levels of parenting competence
Measured: From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
Secondary outcomes (4)
Change in Child Peer Problems After Program (Strengths and Difficulties Questionnaire - Peer Problems Subscale)
- Descriptor: Change in parent-reported child peer problems
Measured: 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)
- Descriptor: Change in parent-reported child peer problems
Measured: 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)
- Descriptor: Change in parent-reported child quality of play
Measured: 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)
- Descriptor: Change in parent-reported child quality of play
Measured: From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start10 Dec 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Amori Yee Mikami, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333887
- Sponsor's protocol ID
- H21-00930
- Acronym
- PFC+
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2022
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05333887
- Acronym / sponsor ID
- PFC+ / H21-00930
- Conditions
- ADHD, Depression
- Keywords
- parent training, ADHD, friendship, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PFC+ | Experimental | Behavioral: 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. |
| Waitlist | No intervention | –In this condition, parents are placed on a waitlist where they continue life as usual. After the waitlist they participate in the PFC+ program. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFC+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. | Behavioural | PFC+ |
Primary outcome
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
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
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.
Early Working Alliance with Therapist (Working Alliance Inventory)
Time frame: Measured in week 2 of the program (after session 2)
- Descriptor: Therapeutic alliance
Post-Treatment Working Alliance with Therapist (Working Alliance Inventory)
Time frame: Measured in week 7 (approximately one week after program completion)
- Descriptor: Therapeutic Alliance
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
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.
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
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
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
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
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
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
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
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
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFC+ in people with ADHD and Depression, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance (how many sessions did they attend) (time frame: The six possible sessions of the program in total, which occur over approximately 7 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.