CompletedNot Applicable

A Prospective Observational Study of Family-based Interventions for Children With Neuropsychiatric and/or Psychiatric Disorders

Finland230 participantsStarted 2013-12

Plain-language summary

The purpose of this study is to examine the feasibility and the effects of family-based interventions for children (aged 5-12) with neuropsychiatric and psychiatric disorders in Finnish health care settings.

Who can participate

Age range

5 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Child is 5-12 year-old at time of recruitment * Child meets screening criteria for neuropsychiatric disorder (i.e. ADHD \& Asperger Syndrome) * Child may also meet screening criteria for co-existing condition such as Behavior Disorder * Family situation is assessed by the health care professional (child psychiatrist) and an intensive family-based intervention is further recommended Exclusion Criteria: * Child's psychiatric condition requires acute inpatient care * Child's parent's alcohol and/or substance abuse requires acute treatment * The progress is going on to correct the conditions that may lead to the child's placement in out-of-home care

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Child's Health Related Quality of Life questionnaire (HRQOL) - (KINDL-R)

Timeframe: Participants will be followed to measure change from baseline to an expected average of 12-18 months & 24 months (when applicable) + 6 months post-intervention follow-up

Multisource Assessment of Children's Socioemotional Competence Scale (MASCS)

Timeframe: Participants will be followed to measure change from baseline to an expected average of 12-18 months & 24 months (when applicable) + 6 months post-intervention follow-up

Parenting Self-Efficacy (PSE)

Timeframe: Participants will be followed to measure change from baseline to an expected average of 12-18 months & 24 months (when applicable) + 6 months post-intervention follow-up

Trial details

NCT IDNCT02250339

SponsorSocial Insurance Institution, Finland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-06-30

View on ClinicalTrials.gov More ADHD trials

Who can participate

Age range

5 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Child's Health Related Quality of Life questionnaire (HRQOL) - (KINDL-R)

Timeframe: Participants will be followed to measure change from baseline to an expected average of 12-18 months & 24 months (when applicable) + 6 months post-intervention follow-up

Multisource Assessment of Children's Socioemotional Competence Scale (MASCS)

Timeframe: Participants will be followed to measure change from baseline to an expected average of 12-18 months & 24 months (when applicable) + 6 months post-intervention follow-up

Parenting Self-Efficacy (PSE)

Timeframe: Participants will be followed to measure change from baseline to an expected average of 12-18 months & 24 months (when applicable) + 6 months post-intervention follow-up