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

Depression Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333887
• Other study ID #: H21-00930
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: University of British Columbia
• Contact: Sophie Smit, MA
• Phone: 604-822-8756
• Email: sophiesmit[@]psych.ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Depression

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	University of British Columbia, Department of Psychology	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Early Working Alliance with Therapist (Working Alliance Inventory)	- Descriptor: Therapeutic alliance	Measured in week 2 of the program (after session 2)
Primary	Post-Treatment Working Alliance with Therapist (Working Alliance Inventory)	- Descriptor: Therapeutic Alliance	Measured in week 7 (approximately one week after program completion)
Primary	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)
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Change in Child Peer Problems After Program (Strengths and Difficulties Questionnaire - Peer Problems Subscale)	- Descriptor: Change in parent-reported child peer problems	From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
Secondary	Change in Child Peer Problems at Follow-Up (Strengths and Difficulties Questionnaire - Peer Problems Subscale)	- Descriptor: Change in parent-reported child peer problems	From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)
Secondary	Change in Child Quality of Play After Program (Quality of Play Questionnaire)	- Descriptor: Change in parent-reported child quality of play	From baseline (week 0) to post-treatment (week 7; approximately one week after program completion)
Secondary	Change in Child Quality of Play at Follow Up (Quality of Play Questionnaire)	- Descriptor: Change in parent-reported child quality of play	From baseline (week 0) to follow-up (week 14; approximately seven weeks after program completion)