Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06040996
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-18
First Post:
2023-08-28
Brief Title:
Evaluation of Improving Parenting Skills Adult ADHD IPSA A New Parent Training Program for Parents With ADHD
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
A Randomized Controlled Trial of Improving Parenting Skills Adult ADHD IPSA A New Parent Training Program for Parents Who Themselves Have ADHD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
IPSA Improving Parenting Skills adult ADHD is a new parent training PT program developed and adapted for parents who themselves have Attention-DeficitHyperactivity Disorder ADHD
This study evaluates the efficacy of the IPSA program that is whether participation in IPSA is associated with desired treatment outcomes eg improved parental self-efficacy In addition it examines the programs feasibility eg what parents think about the program the extent to which parents complete the program and program safety
The study is a so called randomized controlled trial RCT where participants are randomly assigned to one of two groups Treatment IPSA or Control continued routine services offered IPSA approximately six months later
Participants are adults with ADHD any form that have at least one child in the ages between 3 and 11 years Data are primarily collected using questionnaires completed by parents before and after IPSA as well as in connection with an IPSA booster session follow-up
This study evaluates the efficacy of the IPSA program that is whether participation in IPSA is associated with desired treatment outcomes eg improved parental self-efficacy In addition it examines the programs feasibility eg what parents think about the program the extent to which parents complete the program and program safety
The study is a so called randomized controlled trial RCT where participants are randomly assigned to one of two groups Treatment IPSA or Control continued routine services offered IPSA approximately six months later
Participants are adults with ADHD any form that have at least one child in the ages between 3 and 11 years Data are primarily collected using questionnaires completed by parents before and after IPSA as well as in connection with an IPSA booster session follow-up
Detailed Description:
DESIGN An RCT with parallel groups where eligible individuals are block randomized on each clinical site to one of two groups ratio 11 Treatment IPSA directly or Control continued routine services offered IPSA approximately six months later Each block includes 18 participants Randomization is done using a digital randomization tool Allocation treatment or control is masked to participants and study staff administering the screeninginclusionassessment procedures until after the baseline assessment including pre-intervention questionnaires has been completed
SETTING The study is carried out by the Center of Neurodevelopmental Disorders at Karolinska Institutet KIND Karolinska Institutet Sweden in collaboration with an ADHD Center run by the publicly-funded Habilitation Health Stockholm Health Care Services Region Stockholm Sweden Originally the plan was to gradually involve external clinical sites eg regular outpatient psychiatric clinics in the data collection However this plan was first postponed and later cancelled due to the Covid-19 pandemic
ETHICS The study has been approved by the Regional Ethics Committee of Stockholm Sweden dnr 20172435-315 2019-06362 and 2023-03871-02
PARTICIPANTS Parents 18 years of age with a formal ADHD diagnosis any form having at least one child aged 3 to 11 years recruited via the project web site as well as among families enrolled at the involved clinical site
SAMPLE SIZE Power calculations with 1 - β 80 α 05 medium to large effect sizes has resulted in an estimated sample size of n 100
RESEARCH QUESTIONS The research questions are primarily concerned with the efficacy of IPSA secondarily with the feasibility of the program In addition the investigators will explore the potentially moderating or mediating effects of baseline variables and levels of active participation on efficacy outcomes
EFFICACY The effect of IPSA is examined using self- and parental report scales administered before pre T1 and immediately after post T2 IPSA as well as approximately 15-3 months after program completion in connection with an IPSA booster session follow-up T3 Specifically the investigators examine whether participation in IPSA is associated with positive treatment outcomes with respect to the studys primary outcome parental self-efficacy and secondary outcomes parental stress levels of household disorganization or frequency and perception of disruptive behavior problems in the participants target child In addition parents time management and organizational skills are followed from pre to post IPSA
FEASIBILITY The feasibility of IPSA is evaluated based attendance records and parental reports The investigators assess whether IPSA is an acceptable intervention ie treatment satisfaction treatment credibility examine levels of active participation ie program completion rates levels of homework completion use of introduced parenting skills and management of a targeted parent-child interaction situation and monitor potential harms including parental reports of general perceived stress symptoms of anxietydepression and adverse events
TREATMENT INTEGRITY Intervention sessions are recorded audio only Treatment integrity assessed in terms of facilitator adherencefidelity is examined in 20 of group sessions randomly selected using checklists covering program elements and content
SETTING The study is carried out by the Center of Neurodevelopmental Disorders at Karolinska Institutet KIND Karolinska Institutet Sweden in collaboration with an ADHD Center run by the publicly-funded Habilitation Health Stockholm Health Care Services Region Stockholm Sweden Originally the plan was to gradually involve external clinical sites eg regular outpatient psychiatric clinics in the data collection However this plan was first postponed and later cancelled due to the Covid-19 pandemic
ETHICS The study has been approved by the Regional Ethics Committee of Stockholm Sweden dnr 20172435-315 2019-06362 and 2023-03871-02
PARTICIPANTS Parents 18 years of age with a formal ADHD diagnosis any form having at least one child aged 3 to 11 years recruited via the project web site as well as among families enrolled at the involved clinical site
SAMPLE SIZE Power calculations with 1 - β 80 α 05 medium to large effect sizes has resulted in an estimated sample size of n 100
RESEARCH QUESTIONS The research questions are primarily concerned with the efficacy of IPSA secondarily with the feasibility of the program In addition the investigators will explore the potentially moderating or mediating effects of baseline variables and levels of active participation on efficacy outcomes
EFFICACY The effect of IPSA is examined using self- and parental report scales administered before pre T1 and immediately after post T2 IPSA as well as approximately 15-3 months after program completion in connection with an IPSA booster session follow-up T3 Specifically the investigators examine whether participation in IPSA is associated with positive treatment outcomes with respect to the studys primary outcome parental self-efficacy and secondary outcomes parental stress levels of household disorganization or frequency and perception of disruptive behavior problems in the participants target child In addition parents time management and organizational skills are followed from pre to post IPSA
FEASIBILITY The feasibility of IPSA is evaluated based attendance records and parental reports The investigators assess whether IPSA is an acceptable intervention ie treatment satisfaction treatment credibility examine levels of active participation ie program completion rates levels of homework completion use of introduced parenting skills and management of a targeted parent-child interaction situation and monitor potential harms including parental reports of general perceived stress symptoms of anxietydepression and adverse events
TREATMENT INTEGRITY Intervention sessions are recorded audio only Treatment integrity assessed in terms of facilitator adherencefidelity is examined in 20 of group sessions randomly selected using checklists covering program elements and content
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None