Clinical trials: Parents’ experiences

 I wouldn’t say it really came into it because we didn’t, we didn’t give her an option. But then also when they came it was, it was a very positive experience the, it wasn’t scary to her at all. And it seemed like a game. And the fact that she got her sticker chart, and you know did all these things; she has to do certain things to get the stickers, and to her that’s, that’s on her wave length. And that’s kind of as much as she needs to understand, and yeah. And her impression was that they came to play with her. She said to me about a week later, “Those ladies came and hurt my arm.” And that was all she said about it. But other than that, she felt they just came to play and read books with her, that the injection and the blood test side of things was kind of a side line to her.

 And then, as I say we were at the [Hospital] and they were at the point of sort of saying “Well we’ve got this trial on the go, we need some, you know, would you mind a small test since your here”. And I would think yes that’s fine by me. Yes Robert, hearing what he said they would, we would give him minimal information because at that point, certainly you know, as an eight year old decisions about him were down to me really. And yes it was explained to him beforehand well this is just going to happen, you don’t mind do you and in the main he was fine. The only times that we refused it or listened to it and then said no were when it was going to involve blood tests because of his needle phobia. But otherwise pretty much in the main, he just saw it as oh that’s another thing to do, I’ll do it, we’ll do it, we saw it as a yes we know what the ultimate goal is. We know that along the way they have got to look into and collect data, try different things out and they need, you know, people to take part to do that. And it wasn’t intrusive on our lives particularly because usually we’re in clinic, it just happened as an add on maybe once or twice it delayed us leaving the hospital by maybe half an hour or an hour or something. But at that stage when he was a young child or as a child, it didn’t involve us having to make special trips, you know, up there to take part in the trials.

 Yes I would, yes. I, now would probably wait until she was older to be able to make more of an informed, not consent but where she could take, we’re getting to that now where not her, not her cardiac hospital but her, the hospital, we live about an hour away from her cardiac hospital but we have a local hospital, the local trust uses her for exams for the diploma in child health or the diploma not, the membership for the Paediatric exams. And she’s now getting to the point where I won’t just say yes, I will ask her whether she wants to go and do it because that now her little body is changing and things are becoming more and more sensitive about, you know. Taking her top off for any Tom, Dick or Harry whereas when she was three or four the promise of a lollypop was enough to sort of. And now I would involve her more in the decision but trying ultimately to steer her towards saying yes.

 After the first year we then agreed to continue to have extra bloods taken. And also they do this day assessment where your children have to fast and they measure your blood glucose levels, and this extra scan. And we agreed to all that, knowing that we were having more tests than was absolutely necessary, with an overview of, “Well, actually it’s going to be of benefit medically in years to come, but there’s actually no benefit for us now” because it’s just an extra set of bloods, it’s just an extra test. So we did, we, we’ve done that and we’ve actually decided to stop now. We, we’ve come to the end of that period and they asked if you want to carry on and we’ve said, “No”; the reason being that our oldest child is eight and he’s at an age where he doesn’t want to have blood taken, and actually now he doesn’t need to have his blood taken. I think it might just be once a year, if that, or something. You know, we’re really down to the minimum, minimum things with the whole, the whole thing. And actually he doesn’t want to. And so that’s fine and I have to respect that. 

And did you talk to him, to your son, about taking part in the trials?

Yes. We sat Callum down and we said about the growth hormones and taking the trial. And said to him about it and what he wanted to do. And explained that if hopefully taking the growth hormones daily would help increase him to grow, and it was up to him if he wanted to take part in it, or not have growth hormones or anything. And he said that, his words were, “Mummy I want to be like the other children.” So to me he wanted to be and like the other children, and we said it would be like an injection every day. And he said, “Well Granddad has it.” He’s a diabetic, “So Granddad has injections so I’ll have injections to make me grow.” And he’s been fine having injections. And he’s just recently learnt to do it himself so he can do it himself now.

Yeah, and we’ve said to him that any time he didn’t want to, but he said that if that helps other children or other people Mummy then I’m helping other people. So he’s like quite proud that he could be helping other people in the future, and he said they could help other people who were born small like me, because he knows that he was born small, and never caught up. So he thinks that if he does this then it will help others. And he like knows that any time, I’ve said to him if anytime he wanted to come out of the trial he could come out of the trial, and just carry on with his growth hormones. But he’s quite sensible and he wants to do it anyway. Because I thought, being a Mum, I’d let him have the, because it’s his life, let him have the decision.

 I think it was just because it was just out of the blue. We didn’t have any prior warning. We were just sat there, as we do every three months, we sit in clinic. And she just came up to us and just said; “Hello” I can’t remember her name, “Would you be interested in, you know, participating in this survey?” And then she told us a bit about it and obviously... I said yes. Chloe was a bit hesitant. Because twelve months ago she wasn’t as open as she is talking about it. She was very uncomfortable about talking about diabetes. Didn’t really like want anybody to know. So she wouldn’t really talk about it that much. Whereas now she is more comfortable. Still doesn’t like it. If you asked her, she doesn’t like it, but she will, is more open about it. So she was a bit hesitant. And, and I think even after we came away, we said we’d do it, she still wasn’t sure. I think because, I think she thought it would be more involved than it actually was. I think she thought they were asking more of her than they actually were. And really they were only asking, every time we went to clinic, to fill this form in and that was it, there was nothing else to do. I think she thought things were going to come to her house and she’d have to give up her time and do it that way. But it, no, it wasn’t like that. So I think she was surprised really.

She did and she was very down to earth. You know, she just came in, got on the floor and was like, “Right” you know. And that’s what you want, that’s what kids want. They don’t want somebody white coat sat there that they feel they can’t talk to. You know, Sarah asked her questions and felt like she could. Which, which has, you know, helped her because she, she knew, and if she had any questions we’d say, “Well, we’ll phone the, the nurse” you know. Because she knew her first name, that’s what, you know, “We’ll, we’ll phone her and put your mind at rest” or say, you know, “She’s coming out today to see you.” And so she felt a bit special, that somebody’s coming to see her and it’s her special nurse.

 So later on it, you know, it, when we did the trial it was important because we, we wanted to know. And we could explain to her as well that, “You’ve been so ill.” Because she, you know, this, was from the January to the March, and it was the March when we got asked to do it, “You know, it, we might just find out something and be able to help you.” And because she had been so ill as well, I think she was a bit more receptive to, because she’d had enough, hadn’t she? You know, she, she kept saying, “Why me? Why am I always ill? Why. ?” And then, so we were able to say, “Well, let’s see if we can find out.” And, and, and the nurse said that to her as well, didn’t she? So, so it was more, there were all positives for her at that point rather than all she focused on the time before was blood tests, “I’m not having it.”

 And I think when we sat down and explained it to Dan, one of the, one of the reasons we used or explained to him as a child would be that, “If you do this and, and other children do this, then in a couple of years’ time maybe, maybe little boys and girls won’t have to suffer with headaches like you’ve done.” So that’s how we explained it to him and that’s probably how I’d explain it to somebody else who asked, “Why would you choose to put him on a trial?” 

 And then they spoke to my son as well. I was obviously in the same room but they weren’t directing questions to me. They were talking to him. And they asked what he thought about it. Rather than just putting him straight on medication, they explained that it would be really helpful because nobody had ever done a study on childhood migraine before, and would we like to participate? 

 When would you stop, would there come a time when you would stop him taking part?

 No, well, I don’t know. No, it’s not really come up. But I can see that it perhaps will come up. I mean just through the nature of people wanting different things and thinking, you feeling what’s best for your children and them thinking what’s best for them. So I’m sure that, yes, has a potential to be a problem. And I don’t know what you do about it. I suppose ultimately it is their choice, but you’ve got to help them come to that decision, you know, with having all the information that you can give them.

 If they wanted to take part in something that I didn’t want them to take part in, I would have to just find out as much as I could about it. But I mean ultimately it would be their choice. But if I felt I knew something that they weren’t aware of, I think I would present the case, scientific as possible a manner, and just explain to them what I was unhappy with and perhaps explain the consequences of that to them. But ultimately it’s their choice.