NCT05333887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

February 16, 2022

Last Update Submit

March 11, 2026

Conditions

Keywords

parent trainingADHDfriendshipmental health

Outcome Measures

Primary Outcomes (15)

  • 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

    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

    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.

    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 in week 2 of the program (after session 2)

  • Post-Treatment Working Alliance with Therapist (Working Alliance Inventory)

    \- Descriptor: Therapeutic Alliance

    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 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.

    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

    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

    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

    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

    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

    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

    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

    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

    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)

    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)

    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)

    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)

    From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)

Study Arms (2)

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.

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.

Interventions

PFC+BEHAVIORAL

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.

PFC+

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia, Department of Psychology

Vancouver, British Columbia, V6T 1Z4, Canada

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityDepressionPsychological Well-Being

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavioral SymptomsBehaviorPersonal Satisfaction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 16, 2022

First Posted

April 19, 2022

Study Start

December 10, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
After the main manuscript from the study is accepted, for 5 years.
Access Criteria
Investigator with doctoral degree in psychology or related field, or student being supervised by such an investigator.

Locations