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

NCT ID: NCT05333887

Last Updated: 2022-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-10

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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ADHD Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PFC+

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Amori Yee Mikami

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of British Columbia, Department of Psychology

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sophie Smit, MA

Role: CONTACT

604-822-8756

Amori Mikami, PhD

Role: CONTACT

6048223245

Facility Contacts

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Sophie Smit, MA

Role: primary

604-822-8756

Amori Y Mikami, PhD

Role: backup

604-822-3245

Other Identifiers

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H21-00930

Identifier Type: -

Identifier Source: org_study_id

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